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Widler & Schiemann AG can provide you with innovative, creative and cost effective answers to your questions and needs in the areas of Clinical Quality Management. With our vast experience and extensive network in the industry and the regulators we are uniquely positioned to identify and provide the best solutions for you.

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  • 06 March 2023
  • 255
Questions and Answers – Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR)
15 February 2023 – the EMA published the Q&A guidance on CTIS and CTR prepared by the query management working group.
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  • 06 March 2023
  • 164
Clinical Trials Information System (CTIS) Bitesize Talk: Annual Safety Report (ASR)
15 February 2023 – the EMA published the video recording of the ASR bitesize talk.
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  • 06 March 2023
  • 206
ICH Guideline M13A on Bioequivalence for Immediate-release Solid Oral Dosage Forms
16 February 2023 – the EMA published step 2b of the ICH M13A consensus guideline.
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  • 06 March 2023
  • 160
Clinical Trials Information System (CTIS) Training Materials – Latest Updates
21 February 2023 – the EMA published version 1.2 of the CTIS training materials.
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  • 06 March 2023
  • 129
Human Variations Electronic Application Form (eAF)
22 February 2023 – the EMA published the video recordings about eAF.
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  • 28 February 2023
  • 122
ICH E2B(R3) Q&As Reach Step 4 of the ICH Process
23 January 2023 – the ICH announced the updated E2B(R3) Q&A guideline has reached step 4.
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  • 28 February 2023
  • 152
ICH Q9(R1) Guideline Reaches Step 4 of the ICH Process
20 January 2023 – the ICH announced Q9(R1) guideline on Quality Risk Management has reached step 4.
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  • 28 February 2023
  • 115
Dealing with Certification Gaps (MDCG 2022-18)
12 January 2023 – the Swissmedic published guidance on dealing with certification gaps (MDCG 2022-18).
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  • 28 February 2023
  • 121
Notification in Accordance with Art. 10 IvDO for Devices Manufactured in Healthcare Institutions
12 January 2023 – the Swissmedic published guidance on notification for devices manufactured and used in healthcare institutions.
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  • 28 February 2023
  • 107
Changes to the Guidance Document Authorization of Human Medicinal Products under Art. 13 TPA
15 January 2023 – the Swissmedic published updated guidance on changes to the guidance document authorizing the use of human medicinal products.
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  • 28 February 2023
  • 121
Announcements on Clinical Trials with Medical Devices
27 January 2023 – the Swissmedic published updated forms used to report SAEs.
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  • 28 February 2023
  • 227
Good Clinical Practice for Clinical Trials
11 January 2023 – the UK MHRA published updated guidance on upholding GCP standards and what to expect from an inspection.
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  • 28 February 2023
  • 134
Notify the MHRA about a Clinical Investigation for a Medical Device
20 January 2023 – the UK MHRA published updated guidance on how to notify the MHRA of a clinical investigation for a medical device.
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  • 28 February 2023
  • 131
MHRA Innovation Office: Guidance and Support
26 January 2023 – the UK MHRA announced their innovation office can provide regulatory advice.
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  • 28 February 2023
  • 117
Innovative Licensing and Access Pathway
27 January 2023 – the UK MHRA published updated guidance on an innovative licensing and access pathway.
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  • 28 February 2023
  • 134
Format and Content of a Risk Evaluation and Mitigation Strategy (REMS) Document
4 January 2023 – the FDA published the final guidance on the format and content of REMS documents.
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  • 28 February 2023
  • 164
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products –Content and Format
12 January 2023 – the FDA published draft guidance on labeling for industry. Submit comments by 14 March 2023.
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  • 28 February 2023
  • 156
Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases
17 January 2023 – the FDA published draft guidance on identifying optimal dosage for the treatment of oncologic diseases.
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  • 28 February 2023
  • 108
Mpox: Development of Drugs and Biological Products
17 January 2023 – the FDA published draft guidance on Mpox drug development. Submit comments by 21 March 2023.
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  • 28 February 2023
  • 106
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research
23 January 2023 – the FDA published the final guidance on quality considerations for clinical research of cannabis and cannabis-derived compounds for industry.
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  • 28 February 2023
  • 104
Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products
27 January 2023 – the FDA published draft guidance on recommendations for evaluating donor eligibility using individual risk-based questions.
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  • 28 February 2023
  • 117
Acromegaly: Developing Drugs for Treatment
30 January 2023 – the FDA published draft guidance on developing drugs for the treatment of acromegaly. Submit comments by 31 March 2023.
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  • 28 February 2023
  • 194
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
31 January 2023 – the FDA published the draft guidance on the design and conduct of externally controlled trials. Submit comments by 2 May 2023.
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  • 28 February 2023
  • 149
M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
31 January 2023 – the FDA published draft guidance on ICH M13A. Submit comments by 3 April 2023.
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  • 28 February 2023
  • 141
Eudravigilance Registration Documents
4 January 2023 – the EMA published updated instructions for Eudravigilance registration documents.
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  • 28 February 2023
  • 180
Guidance on Good Manufacturing Practice and Good Distribution Practice: Questions and Answers
5 January 2023 – the EMA published updated Q&A guidance on GDP.
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  • 28 February 2023
  • 121
ICH Guideline Q13 on Continuous Manufacturing of Drug Substances and Drug Products
6 January 2023 – the EMA published updated ICH guideline Q13, step 5.
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  • 28 February 2023
  • 174
Coordination of Pharmacovigilance Inspections
12 January 2023 – the EMA published updated Q&A guidance on human PV inspections.
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  • 28 February 2023
  • 127
ICH Guideline M10 on Bioanalytical Method Validation and Study Sample Analysis – Questions and Answers
13 January 2023 – the EMA published updated Q&A guidance on ICH guideline M10.
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  • 28 February 2023
  • 116
EMA Certificates of Medicinal Products – Instructions on How to Fill the Application Form
16 January 2023 – the EMA published instructions on how to fill out the application form for EMA certificates of medicinal products.
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  • 28 February 2023
  • 101
Products Management Services (PMS) – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe
18 January 2023 – the EMA published the implementation of ISO for the identification of medicinal products in EU.
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  • 28 February 2023
  • 112
New Organization First User QPPV/RP or Change of EU QPPV/RP
0 January 2023 – the EMA published updated guidance on EU QPPV/RP.
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  • 28 February 2023
  • 163
Clinical Trial Information System (CTIS) Evaluation Timelines
26 January 2023 – the EMA published version 1.2 of the CTIS training program on evaluation timelines.
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  • 28 February 2023
  • 176
Transitional Trials from EudraCT to CTIS
26 January 2023 – the EMA published Module 23, version 1.3 as well as FAQs of the CTIS training program.
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  • 28 February 2023
  • 99
Guide on CTIS Common Features: Overview of CTIS Workspaces and Common System Functionalities
30 January 2023 – the EMA published Module, version 2 of the updated CTIS training program.
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  • 28 February 2023
  • 104
Quick Guide for Sponsors – Regulation 536/2014 in Practice (Eudralex vol. 10)
30 January 2023 – the European Commission (EC) published the quick guide for sponsors on EU regulation 536/2014 in practice.
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  • 28 February 2023
  • 196
Q&A on the Protection of Commercially Confidential Information and Personal Data while Using CTIS
31 January 2023 – the EMA published Q&A guidance on confidential information and personal data when using CTIS.
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  • 28 February 2023
  • 170
Use of Clinical Trials Information System (CTIS) Becomes Mandatory for New Clinical Trial Applications (CTAs) in the EU
31 January 2023 – the EMA announced mandatory use of CTIS for new CTAs in the EU.
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  • 31 January 2023
  • 160
Navigating a successful entry into the Chinese pharmaceutical market
30 - January 2023, Princeton, NJ - Martin E. Zuzulo, Managing Director, Americas at Widler & Schiemann, LLC, outlines the challenges and opportunities for US companies entering the Chinese market.
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  • 06 January 2023
  • 231
Expansion of Scope of Temporary Authorizations
1 December 2022 – the Swissmedic published guidance on temporary authorizations.
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  • 06 January 2023
  • 220
Clarification of Terminology for Combination Products (Medicinal Products with a Medical Device Component)
15 December 2022 – the Swissmedic published guidance on clarification of terminology for combination products.
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  • 06 January 2023
  • 240
Updated Swissmedic / Swissethics Position Paper on Decentralized Clinical Trials (DCTs) of Medicinal Products
22 December 2022 – the Swissmedic updated the position paper on decentralized clinical trials of medicinal products.
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  • 06 January 2023
  • 209
Register Medical Devices to Place on the Market
6 December 2022 – the MHRA published updated guidance on the registration of medical devices.
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  • 06 January 2023
  • 201
Medicines: Apply for a Parallel Import License
9 December 2022 – the MHRA published updated guidance on applying for a parallel import license.
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  • 06 January 2023
  • 218
Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards
14 November 2022 – the FDA announced a webinar on 13 January 2023 to discuss standards for reporting ICSRs to FAERS.
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  • 06 January 2023
  • 188
Statistical Approaches to Establishing Bioequivalence
2 December 2022 – the FDA published draft guidance on statistical approaches to establishing bioequivalence for industry.
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  • 06 January 2023
  • 197
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
2 December 2022 – the FDA published the draft guidance on the abbreviated new drug applications (ANDAs) for industry.
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  • 06 January 2023
  • 182
E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials
5 December 2022 – the FDA published final ICH E19 guidance for industry.
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  • 06 January 2023
  • 176
Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer
6 December 2022 – the FDA published final guidance on PK-based criteria to support the approval of alternative dosing regimens for PD-1 or PD-L1 blocking antibodies for treating cancer patients.
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  • 06 January 2023
  • 238
Drug Products Labeled as Homeopathic
7 December 2022 – the FDA published final guidance on homeopathic drug products for FDA staff and industry.
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  • 06 January 2023
  • 311
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
9 December 2022 – the FDA published draft guidance on the VMSR program for industry and FDA staff. Submit comments by 7 February 2023.
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  • 06 January 2023
  • 221
Content of Human Factors Information in Medical Device Marketing Submissions
9 December 2022 – the FDA published the draft guidance on medical device marketing submissions for industry and FDA staff. Submit comments by 9 March 2023.
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  • 06 January 2023
  • 145
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe
14 December 2022 – the FDA published final guidance on failure to respond to an ANDA complete response letter.
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  • 06 January 2023
  • 152
Pulmonary Tuberculosis: Developing Drugs for Treatment
14 December 2022 – the FDA published draft guidance on developing drugs for treatment of pulmonary tuberculosis. Submit Comments by 13 February 2023.
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  • 06 January 2023
  • 183
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
15 December 2022 – the FDA published the draft guidance for industry on circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection.
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  • 06 January 2023
  • 157
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
15 December 2022 – the FDA published final guidance on drug labeling for cardiovascular outcome claims for hypertension.
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  • 06 January 2023
  • 156
M11 Clinical Electronic Structured Harmonized Protocol
21 December 2022 – the FDA published draft guidance on the ICH M11 clinical electronic structured harmonized protocol.
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  • 06 January 2023
  • 166
Controlled Correspondence Related to Generic Drug Development
21 December 2022 – the FDA published draft guidance on controlled correspondence related to generic drug development.
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  • 06 January 2023
  • 158
Manual on Borderline and Classification for Medical Devices under Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices
In December 2022 – the European Commission published version 2 of the manual on borderline and classification for medical devices.
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  • 06 January 2023
  • 169
ICH Guideline E8 (R1) on General Considerations for Clinical Studies
2 December 2022 – the EMA published step 5 of ICH Guideline E8 (R1).
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  • 06 January 2023
  • 198
Human Variations Electronic Application Forms (eAF) (DADI) Go-live Q&A Session
6 December 2022 – the EMA published the Q&A guidance on human variations eAF go-live Q&A session held on 27 October 2022 and 8 November 2022.
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  • 06 January 2023
  • 207
EMA EudraVigilance Registration Documents and Manual
7 December 2022 – the EMA published the updated EudraVigilance registration related documents and manual.
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  • 06 January 2023
  • 137
EMA Human Regulatory Update on Medical Devices
8 December 2022 – the EMA updated guidance on medical devices.
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  • 06 January 2023
  • 220
Joint Audit Program for EEA GMP Inspectorates (JAP)
8 December 2022 – the EMA published revision 3 of the audit notification template for EEA GMP inspectorates (JAP).
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  • 06 January 2023
  • 128
Guidance for Applicants/MAHs Involved in GMP, GCP and GVP Inspections Coordinated by EMA
13 December 2022 – the EMA published version 3.1 of guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA.
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  • 06 January 2023
  • 235
Recommendation Paper on Decentralized Elements in Clinical Trials
13 December 2022 – the European Commission published the recommendation paper on decentralized elements in clinical trials, version 01.
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  • 06 January 2023
  • 189
Functional Specifications for the European Database on Medical Devices (EUDAMED)
14 December 2022 – the European Commission published guidance on functional specifications for EUDAMED.
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  • 06 January 2023
  • 164
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) User Manual
15 December 2022 – the EMA published version 5.8 of the XEVMPD data-entry tool user manual.
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  • 06 January 2023
  • 198
Clinical Pharmacology and Pharmacokinetics: Questions and Answers
16 December 2022 – the EMA published updated Q&A guidance on guideline requirements for parenteral oily solutions.
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  • 06 January 2023
  • 162
Q&A: Good Clinical Practice (GCP)
16 December 2022 – the EMA published updated GCP Q&A guidance.
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  • 06 January 2023
  • 160
Updated IRIS Guide to Registration and RPIs
16 December 2022 – the EMA published updated preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration.
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  • 06 January 2023
  • 168
EU Guideline on Orphan Applications (for Designation and Transfer) - 2022/C 440/02
19 December 2022 – the European Commission published the guideline on orphan applications.
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  • 06 January 2023
  • 126
EMA Clinical Trials Highlights
21 December 2022 – the EMA published Issue 12 of the Clinical Trials Highlights newsletter.
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  • 06 January 2023
  • 161
Clinical Trials Information System (CTIS) – Sponsor Handbook
22 December 2022 – the EMA published version 3.01 of the CTIS sponsor handbook.
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  • 12 December 2022
  • 206
NMPA Announcement on Putting into Use the Electronic Certificates of Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product
31 October 2022 – NMPA announced putting into use the electronic certificates of Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product (No. 95, 2022).
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  • 12 December 2022
  • 230
Regulatory Guidelines for Laboratory Developed Tests (LDTs)
24 November 2022 – Singapore Health Sciences Authority (HSA) issued revision one of its regulatory guidelines for LDTs.
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  • 12 December 2022
  • 208
Public Consultation on ICH Guidelines M11 “Clinical electronic Structured Harmonized Protocol (CeSHarP)” and Q5A(R2) “Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin”
28 November 2022 – Swissmedic launched the public consultation on ICH guidelines M11 and Q5A(R2), with a deadline for comments of 26 February 2023 and 10 February 2023, respectively.
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  • 12 December 2022
  • 181
Changes to the Guidance Document Variations TAM HMV4
4 November 2022 – Swissmedic announced an extended reporting time limit of 60 days that applies to variations without assessment.
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  • 12 December 2022
  • 207
Issue of Export Certificates (Free Sales Certificates) for Medical Devices
8 November 2022 – Swissmedic announced the adaptation of the export certificates ordering process for medical devices beginning 1 January 2023.
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  • 12 December 2022
  • 268
MHRA Process for Approving Manufacturing Authorizations or API Registrations in Relation to Unlicensed Cannabis-Based Products for Medicinal Use (CBPMs)
16 November 2022 – MHRA Inspectorate published the blog on MHRA process for approving unlicensed CBPMs.
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  • 12 December 2022
  • 247
Borderline Products: How to Tell if Your Product is a Medical Device and Which Risk Class Applies
16 November 2022 – MHRA updated guidance on medical device borderline products.
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  • 12 December 2022
  • 241
European Commission (EC) Decision Reliance Procedure (ECDRP)
18 November 2022 – MHRA updated guidance on the EC decision reliance procedure.
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  • 12 December 2022
  • 197
Return to International GMP Inspections
8 November 2022 – MHRA Inspectorate published the blog on return to international GMP inspections.
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  • 12 December 2022
  • 195
Access Consortium Good Manufacturing Practice (GMP) Statement
15 November 2022 – MHRA published access consortium statement on GMP inspections reliance and recognition.
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  • 12 December 2022
  • 181
Enforcement Policy Regarding Investigational New Drug (IND) Requirements for Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies
28 November 2022 – FDA published its policy on IND requirements for FMT use.
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  • 12 December 2022
  • 187
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide
1 November 2022 – FDA published the final Small Entity Compliance guidance on HCT/Ps regulations.
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  • 12 December 2022
  • 176
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
1 November 2022 – FDA published draft Q&A guidance on expanded access to investigational drugs for treatment use. Submit comments by 3 January 2023.
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  • 12 December 2022
  • 188
S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals
2 November 2022 – FDA published S1B(R1) as an addendum to the current ICH S1 guidance for industry.
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  • 12 December 2022
  • 229
Cross Labeling Oncology Drugs in Combination Regimens
2 November 2022 – FDA published final guidance on cross labeling oncology drugs for industry.
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  • 12 December 2022
  • 197
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial
4 November 2022 – FDA published final guidance for studies that evaluate multiple versions of a cellular or gene therapy product.
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  • 12 December 2022
  • 246
M10 Bioanalytical Method Validation and Study Sample Analysis
4 November 2022 – FDA published the final guidance on M10 bioanalytical method validation and study sample analysis.
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  • 12 December 2022
  • 185
Sameness Evaluations in an ANDA — Active Ingredients
8 November 2022 – FDA published draft guidance on sameness evaluations in an ANDA. Submit comments by 8 January 2023.
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  • 12 December 2022
  • 190
Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
10 November 2022 – FDA published draft guidance on Q5A(R2) viral safety evaluation of biotechnology products. Submit comments by 14 January 2023.
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  • 12 December 2022
  • 170
Reflection Paper on Criteria to be Considered for the Evaluation of New Active Substance (NAS) Status of Biological Substances
18 November 2022 – EMA published draft guidance on criteria for the evaluation of NAS status of biological substances for consultation. Comments may be submitted until 31 May 2023.
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  • 12 December 2022
  • 200
Annual Report of the Good Clinical Practice (GCP) Inspectors Working Group (IWG) 2021
21 November 2022 – EMA published the annual report of the GCP IWG 2021.
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  • 12 December 2022
  • 189
IRIS Guide to Registration and RPIs
21 November 2022 – EMA published version 2.10 of the preliminary requirements for all IRIS submissions, including substance and research product identifier registration.
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  • 12 December 2022
  • 174
Guidance for Applicants on Simultaneous National Scientific Advice (SNSA) Phase 2 Pilot (from October 2022) – Optimized Process
21 November 2022 – EMA updated the guidance for SNSA phase 2 pilot.
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  • 12 December 2022
  • 185
ICH Guideline Q3C (R8) on Impurities: Guideline for Residual Solvents
28 November 2022 – EMA updated step 5 of the ICH guideline Q3C(R8) on residual solvents.
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  • 12 December 2022
  • 216
Records of Data Processing Activity (public) Regarding the Processing of Personal Data in the Clinical Trials Information System (CTIS)
28 November 2022 – EMA published updated guidance on CTIS data processing activities.
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  • 12 December 2022
  • 173
Union Guidance on Record Keeping and Archiving of Documents Obtained or Resulting from Pharmacovigilance (PV) Inspections
29 November 2022 – EMA published guidance on record keeping and archiving of documents related to EU PV inspections.
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Quality by Design

Our extensive track record and our close collaboration with regulators positions us uniquely to support clients in QbD projects with the latest development in methodologies and regulations.

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Quality Risk Management

As recognized experts in QRM we provide leading edge knowledge and support to clients developing and implementing a QRM approach.

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Risk-based Monitoring & Study Management

With the QbD and QRM methodologies we are in a unique position to help you design your new approach to a targeted and centralized monitoring and study management approach.

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SOP Management and Re-engineering

We have developed and successfully deployed a new approach to SOP management. Structured Content Management (SCM) allows tailoring the content of an SOP to the exact needs of each user group. With this we have created a whole set of clinical development SOPs that can easily be deployed in your company.

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Quality Strategy, Quality Policy & Quality Manuals

Many years of experience with large and small organizations developing Quality Strategies and key Quality documentation such as Quality Policy and Manual tailored to the customers specific needs.

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We have worked with large and small organizations and helped them develop and deploy a fit-for-purpose QMS. Their experience has allowed them to detect early obstacles or even resistance and to propose the right change management steps.

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GCP, Quality Risk Management & Quality Methodology Training

We are proud to be able to offer you tailored training courses as an in-house training for your staff either as refresher training or for newcomers.

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Service Provider & Vendor Qualification and Assessment

We have extensive experience in qualifying vendors and designing processes ranging from pre-contract assessments (risk based) to in process audits and quality risk assessments.

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GCP Issue Management

We have combined more than 35 years of experience in the GCP field and are viewed by many of our peers in the industry as thought-leaders in compliance matters and issues.

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We have a demonstrated track record of successful implementations of QA plans and strategies as well as CAPA (Corrective and Preventive Action) programs and QA infrastructure and organizations.

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We have developed and implemented processes to make organizations inspection ready. A toolkit has been developed to assist teams and functions to reach an inspection ready state.

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Quality Management of Pharmacovigilance Processes

We have developed a systematic approach to ensuring a continuous oversight on safety reporting whether in clinical trials or of spontaneous cases from marketed products. This methodology is based on the QbD and QRM principle and can be tailored to the customers' need.

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Corporate Compliance

With our experience we are best positioned to define the systems’ requirements, perform a risk analysis and define and rollout of processes for health care compliance.

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Regulatory Intelligence Clinical Quality & Risk Management

Through our network, we are uniquely placed to learn early of planned changes that may impact your operations and even more important we are able to put these in the right legal and regulatory context to guide you to make the right process and organizational changes or to confidently refuse any change.

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