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  • 19 July 2022
  • 47
Questions & Answers - Practical Arrangements on the Companion Diagnostics Consultation Procedure to the European Medicines Agency by Notified Bodies
1 July 2022 — EMA published updated Q&A guidance on diagnostic consultation procedures.
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  • 19 July 2022
  • 554
Guidance on Applying the 2021 Advertising Code Rules
1 July 2022 — Australian Therapeutic Goods Administration (TGA) published the guidance on applying the advertising code rules for therapeutic goods.
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  • 19 July 2022
  • 50
Guideline on Advertising, etc. of Medicinal Products for Human Use
5 July 2022 — Danish Medicines Agency updated guideline on advertising of medicinal products for human use.
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  • 19 July 2022
  • 54
Identifying Trading Partners Under the Drug Supply Chain Security Act
5 July 2022 — FDA issued the draft guidance for industry. Submit comments by 05 September 2022.
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  • 19 July 2022
  • 44
OPEN Pilot: One-year Review and Recommendations
7 July 2022 — EMA published the OPEN Pilot report.
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  • 19 July 2022
  • 71
Consultation on Regulatory Guidelines for Laboratory Developed Tests (LDTs)
12 July 2022 — Singapore Health Sciences Authority (HAS) announced the release of a draft regulatory guidelines for LDTs for stakeholders' consultation.
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  • 19 July 2022
  • 140
Information about the Raw Data Proof-of-Concept Pilot for Industry
12 July 2022 — EMA announced the availability of access to raw data for marketing authorization and post-authorization applications submitted to the EMA.
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  • 19 July 2022
  • 62
GCP Inspection Site Report Template on Behalf of the EMA
12 July 2022 — EMA published the updated GCP inspection procedures for appendix 1 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP.
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  • 19 July 2022
  • 54
Joint Controllership Arrangement: EudraVigilance Human (EV) Personal Data Capture
13 July 2022 — EMA published legal framework for the purpose of processing personal data captured in EudraVigilance Human (EV) administered by EMA
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  • 19 July 2022
  • 42
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological
14 July 2022 — FDA published the final guidance for industry.
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  • 19 July 2022
  • 75
Horizon Scanning Case Study: Point of Care Manufacture
15 July 2022 — UK MHRA published the horizon scanning case study.
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  • 19 July 2022
  • 52
The ICH Drug Interaction Studies M12 Draft Guideline Now Available Online
ICH announced the availability of the M12 draft guideline presentation.
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  • 19 July 2022
  • 55
Technology Capability Investment Plan
15 July 2022 — EMA published technology capability investment plan for becoming the digital hub for the European Medicines Regulatory Network.
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  • 19 July 2022
  • 64
European Medicines Agency’s Data Protection Notice for EudraVigilance Human (EV)
15 July 2022 — EMA published updated data protection notice for EudraVigilance Human.
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  • 11 July 2022
  • 85
Questions and Answers - Complex Clinical Trials
2 June 2022 — European Commission published updated Q&A guidance on complex clinical trials, version 2022-05-23.
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  • 11 July 2022
  • 85
Compliance Monitor (CM) Overview and Application Process
15 June 2022 — MHRA published updated guidance on the eligibility of the compliance monitor.
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  • 11 July 2022
  • 66
Marketing Authorization Application (MAA) Submission Dates for 150-days National and European Commission Decision Reliance Procedures
20 June 2022 — MHRA published updated guidance on MAA submission dates.
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  • 11 July 2022
  • 88
Guidance on Handling of Decentralized and Mutual Recognition Procedures Which are Approved or Pending
24 June 2022 — MHRA published updated guidance on the approach the MHRA intends to take for products approved or pending in decentralized procedure (DCP) or mutual recognition procedures (MRP).
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  • 11 July 2022
  • 97
European Medicines Agency Post-Authorization Procedural Advice for Users of the Centralized Procedure
20 June 2022 — EMA published updated Q&A guidance on extensions of marketing authorizations.
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  • 11 July 2022
  • 78
European Medicines Agency Pre-Authorization Procedural Advice for Users of the Centralized Procedure
20 June 2022 — EMA published updated pre-authorization Q&A guidance.
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  • 11 July 2022
  • 72
Updated IRIS Guide for Industry and Individual Applicants
28 June 2022 — EMA published the updated IRIS guide on how to create and submit scientific applications.
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  • 11 July 2022
  • 105
Workshop Report on Data Quality Framework for Medicines Regulation
29 June 2022 — EMA published workshop report on data quality framework for medicines regulation.
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  • 11 July 2022
  • 78
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) User Manual
7 June 2022 — EMA published version 5.7 of the EVWEB user manual.
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  • 11 July 2022
  • 75
Article 57 User Interface (UI) Installation Guide
7 June 2022 — EMA published updated installation guide on article 57 UI components and initial set-up.
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  • 11 July 2022
  • 74
Orphans: Regulatory and Procedural Guidance and Forms
9 June 2022 — EMA announced updated procedural guidance documents on orphan designation.
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  • 11 July 2022
  • 71
Changing the Name or Address of a Sponsor
9 June 2022 — EMA announced update for submitting a request to change the name or address.
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  • 11 July 2022
  • 68
Mandatory Use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Using the EudraVigilance System
15 June 2022 — EMA announced EudraVigilance System online training course.
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  • 11 July 2022
  • 66
Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
16 June 2022 — FDA published the final guidance for industry and FDA staff.
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  • 11 July 2022
  • 67
Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures
21 June 2022 — FDA issued draft guidance for industry and FDA staff. Submit comments by 22 August 2022.
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  • 11 July 2022
  • 77
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
24 June 2022 — FDA published final guidance.
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  • 11 July 2022
  • 82
Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
27 June 2022 — FDA issued draft guidance for comments by 25 September 2022.
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  • 11 July 2022
  • 81
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment
27 June 2022 — FDA published final industry guidance on the treatment of renal cell carcinoma.
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  • 11 July 2022
  • 73
Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment
27 June 2022 — FDA published final industry guidance on the treatment of bladder cancer.
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  • 11 July 2022
  • 141
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
29 June 2022 — FDA issued draft guidance for comments by 28 September 2022.
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  • 11 July 2022
  • 56
Electromagnetic Compatibility (EMC) of Medical Devices
6 June 2022 — FDA issued guidance on EMC for industry and FDA staff.
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  • 11 July 2022
  • 76
Q9(R1) Quality Risk Management
14 June 2022 — FDA issued draft guidance for comments by 15 July 2022.
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  • 11 July 2022
  • 63
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
15 June 2022 — FDA issued draft guidance for comments by 14 September 2022.
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  • 02 June 2022
  • 201
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
On 16 May 2022 the FDA published Final Level 2 revised guidance.
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  • 02 June 2022
  • 190
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors
On 18 May 2022 the FDA published the final guidance on safety considerations for labeling.
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  • 02 June 2022
  • 167
How to Notify the MHRA about a Clinical Investigation for a Medical Device
On 19 May 2022 the UK MHRA updated the guidance on notifying the MHRA of the intention to conduct a clinical investigation for medical devices.
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  • 02 June 2022
  • 141
Annual Report of the Good Clinical Practice Inspectors’ Working Group 2020
On 20 May 2022 the EMA published the annual report of the GCP IWG, which was adopted by the GCP IWG on 30 April 2022.
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  • 02 June 2022
  • 132
Risk Management Plans to Mitigate the Potential for Drug Shortages
On 20 May 2022 the FDA published the draft guidance on risk management plans for drug shortages. Comments may be submitted until 19 July 2022.
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  • 02 June 2022
  • 141
Medicines Shortages: Regulatory Processes to Manage Supply Disruptions
On 23 May 2022 the UK MHRA published the guidance on regulatory processes to manage supply disruptions.
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  • 02 June 2022
  • 202
Addendum to the Guideline on the Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections to Address Paediatric-specific Clinical Data Requirements
On 24 May 2022 the EMA published the addendum to the guideline on evaluation of medicinal products indicated for treatment of bacterial infections.
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  • 02 June 2022
  • 138
Guideline on the Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections
On 24 May 2022 the EMA published the revised guideline on the evaluation of human medicines for the treatment of bacterial infections, revision 3.
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  • 02 June 2022
  • 160
Clinical Trials Highlights – May 2022
On 25 May 2022 the EMA published Clinical Trials Highlights - Issue 9.
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  • 02 June 2022
  • 146
Supervise a Clinical Trial: Inspection Records – CTIS Training Programme – Module 16
On 25 May 2022 the EMA published FAQs on clinical trial inspection records.
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  • 02 June 2022
  • 139
Q&A on the Interface between Regulation (EU) 536/2014 on Clinical Trials for Medicinal Products for Human Use (CTR) and Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices (IVDR)
On 25 May 2022 the European Commission published Q&A guidance on the interface between the EU CTR and IVDR.
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  • 02 June 2022
  • 143
Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1)
On 25 May 2022 the FDA published the draft Q&A guidance, revision 1. Comments may be submitted until 24 July 2022.
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  • 02 June 2022
  • 126
Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide
On 25 May 2022 the FDA published the final Q&A guidance for industry.
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  • 02 June 2022
  • 129
New Regulations Applicable to In Vitro Diagnostic Medical Devices
On 26 May 2022 the Swissmedic announced the entry into force of the new regulations on in vitro diagnostic medical devices.
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  • 02 June 2022
  • 120
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues
On 27 May 2022 the FDA published the final guidance for industry.
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  • 02 June 2022
  • 150
Questions and Answers Document – Regulation (EU) 536/2014
On 30 May 2022 the European Commission published Q&A guidance on the Clinical Trials Regulation, version 6.1.
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  • 02 June 2022
  • 140
Updated Frequently Asked Questions about Parallel Distribution
On 31 May 2022 the EMA published updated FAQs about parallel distribution.
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  • 16 May 2022
  • 174
Risklick Provides Clinical Trial Educational Programs
The Clinical Trial Academy Essential Program provided by Risklick is aimed to address the difficulties in developing an ideal clinical trial protocol.
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  • 16 May 2022
  • 170
Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development
On 2 May 2022 the FDA announced the availability of the draft guidance for industry.
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  • 16 May 2022
  • 153
ICH Guideline Q3D (R2) on Elemental Impurities
On 3 May 2022 the EMA published step 5 of the revised ICH guideline Q3D (R2) on elemental impurities.
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  • 16 May 2022
  • 151
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 4 May 2022 the FDA published the final guidance for industry and FDA staff.
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  • 16 May 2022
  • 157
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
On 5 May 2022 the FDA published the draft guidance for industry. Comments may be submitted until 4 August 2022.
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  • 16 May 2022
  • 262
Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
On 5 May 2022 the FDA published the draft guidance for industry and FDA staff. Comments may be submitted until 5 July 2022.
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  • 16 May 2022
  • 155
Updated Good Clinical Practice (GCP) Inspection Procedures
On 5 May 2022 the EMA announced the updates of the guidance on GCP inspection procedures.
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  • 16 May 2022
  • 177
Guidelines on MedDRA Coding for Drug Marketing Authorization Holders
On 6 May 2022 the Chinese NMPA issued the MedDRA coding guidelines for the MAHs.
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  • 16 May 2022
  • 176
Compliance Monitor Process (Part 2) – CM Role and Application Process
On 10 May 2022 the UK MHRA Inspectorate published the second part of the compliance monitor process.
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  • 16 May 2022
  • 154
Benefit-Risk Considerations for Product Quality Assessments
On 10 May 2022 the FDA published the draft guidance for industry. Comments may be submitted until 10 July 2022.
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  • 05 May 2022
  • 193
NMPA Guidelines for Pharmacovigilance Inspection
On 15 April 2022 the Chinese NMPA published the announcement of distributing the PV inspection guidelines (NMPA [2022] No. 17).
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  • 05 May 2022
  • 259
Annual Report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2021
On 20 April 2022 the EMA published annual report of the GMP/GDP Inspectors Working Group (IWG).
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  • 05 May 2022
  • 215
Overview of Comments Received on ICH Guideline Q9 (R1) on Quality Risk Management
On 20 April 2022 the EMA published comments on ICH guideline Q9(R1) on quality risk management.
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  • 05 May 2022
  • 200
2021 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission
On 20 April 2022 the EMA published the 2021 EudraVigilance annual report (1 Jan to 31 Jan 2021).
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  • 05 May 2022
  • 270
Compilation of Union Procedures on Inspections and Exchange of Information
On 20 April 2022 the EMA published the compilation of union procedures on inspections and exchange of information.
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  • 05 May 2022
  • 199
PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities
On 21 April 2022 the EMA issued PV guidance revision 2 on the Pharmacovigilance Risk Assessment Committee (PRAC) strategy.
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  • 05 May 2022
  • 274
Refuse to Accept Policy for 510(k)s
On 21 April 2022 the FDA published the final guidance for industry and FDA staff.
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  • 05 May 2022
  • 181
Drug Products, Including Biological Products, that Contain Nanomaterials
On 21 April 2022 the FDA published the final guidance for industry on drug products with nanomaterials.
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  • 05 May 2022
  • 161
Providing Submissions in Electronic Format — Postmarketing Safety Reports
On 27 April 2022 the FDA published the final guidance on electronic submissions of postmarketing safety reports for industry.
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  • 05 May 2022
  • 181
ICH E8(R1) General Considerations for Clinical Studies
On 28 April 2022 the ICH announced that Step 4 - Introductory Training Presentation – is available on the ICH website.
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  • 05 May 2022
  • 180
Compliance Monitor (CM) Overview and Application Process
On 29 April 2022 the UK MHRA published guidance on the CM overview and application process.
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  • 19 April 2022
  • 374
Update to Guidance document "Information on PSUR / PBRER submission"
Effective 1 April 2022, Swissmedic updated the Guidance document, allowing a transition period of 30 days.
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  • 19 April 2022
  • 200
Good Clinical Practice for Medical Devices
On 2 April 2022 the Chinese NMPA issued an announcement for the GMP for clinical trials of medical devices (No. 28 of 2022).
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  • 19 April 2022
  • 260
Guidance for Applicants/MAHs Involved in GMP and GCP Inspections Coordinated by EMA
On 2 April 2022 the EMA published guidance for applicants/MAHs involved in GMP and GCP inspections.
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  • 19 April 2022
  • 261
M7(R2) Addendum: Application of The Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes
On 6 April 2022 the FDA published draft guidance on ICH M7 addendum for industry.
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  • 19 April 2022
  • 199
Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment
On 6 April 2022 the FDA published the final guidance on developing drugs for chronic hepatitis B virus infection.
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  • 19 April 2022
  • 253
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
On 7 April 2022 the FDA published the draft Q&A guidance for industry. Comments may be submitted until 7 Jun 2022.
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  • 19 April 2022
  • 226
General Considerations for Clinical Studies – E8(R1)
On 7 April 2022 the FDA published the final guidance on ICH E8(R1) general considerations for clinical studies.
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  • 19 April 2022
  • 212
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
On 8 April 2022 the FDA published draft guidance on cybersecurity in medical devices for industry and FDA staff. Comments may be submitted until 7 Jul 2022.
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  • 19 April 2022
  • 290
Draft Guidance Document on How to Approach the Protection of Personal Data and Commercially Confidential Information in Documents Uploaded and Published in the Clinical Trial Information System (CTIS)
On 8 April 2022 the EMA published draft guidance on protection of personal data and commercially confidential information in CTIS.
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  • 19 April 2022
  • 219
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs
On 11 April 2022 the FDA published the final guidance for industry.
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  • 19 April 2022
  • 326
Updated Frequently Asked Questions about Parallel Distribution
On 12 April 2022 the EMA updated the FAQ/General Question No. 22.
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  • 19 April 2022
  • 227
Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials
On 13 April 2022 the FDA announced the availability of the draft guidance for industry.
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  • 19 April 2022
  • 189
Updated IRIS Guide for Applicants
On 13 April 2022 the EMA published version 2.8 of the IRIS guide on how to create and submit scientific applications, for industry and individual applicants.
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  • 19 April 2022
  • 188
Questions and Answers Document – Regulation (EU) 536/2014
On 13 April 2022 the European Commission published Q&A guidance on Clinical Trials Regulation (EU) 536/2014, version 6.
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  • 19 April 2022
  • 198
Detailed Guidance on ICSRs in the Context of COVID-19
On 13 April 2022 the EMA published updated guidance revision 3, clarifying the validity and coding of ICSRs linked to COVID-19.
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  • 19 April 2022
  • 209
Points to Consider on the Impact of the War in Ukraine on Methodological Aspects of Ongoing Clinical Trials
On 13 April 2022 the EMA published guidance on actions for ongoing clinical trials affected by the war in Ukraine.
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  • 19 April 2022
  • 224
Bioavailability Studies Submitted in NDAs or INDs – General Considerations
On 14 April 2022 the FDA published final guidance on general considerations for bioavailability studies submitted in NDAs or INDs.
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  • 01 April 2022
  • 416
Updated EMA EudraVigilance Registration Manual
On 17 March 2022 the EMA updated the EudraVigilance registration manual.
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  • 01 April 2022
  • 241
Updated EMA Post-authorization Procedural Advice for Users of the Centralized Procedure
On 18 March 2022 the EMA updated the EudraVigilance registration manual.
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  • 01 April 2022
  • 372
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4
On 22 March 2022 the FDA published final guidance for industry.
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  • 01 April 2022
  • 353
An Acceptable Circular of Information for the Use of Human Blood and Blood Components
On 22 March 2022 the FDA published final guidance for industry.
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  • 01 April 2022
  • 242
"Measures for the Supervision and Administration of Medical Device Production" and "Measures for the Supervision and Administration of Medical Device Operation"
On 23 March 2022 the Chinese NMPA published two guidelines on medical device production and operation.
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  • 01 April 2022
  • 410
Announcement on the Release of Guidelines for the Preparation of Annual Self-inspection Reports for Medical Device Quality Management Systems (No. 13 of 2022)
On 24 March 2022 the Chinese NMPA announced the release of guidelines on annual self-inspection reports for medical device quality management systems effective 1 May 2022.
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  • 01 April 2022
  • 253
ICH Guideline E14/S7B: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential — Q&A Step 5
On 24 March 2022 the EMA published the ICH Q&A guideline E14/S7B.
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  • 01 April 2022
  • 291
Emergency Use Authorization for Vaccines to Prevent COVID-19
On 31 March 2022 the FDA published final guidance for industry.
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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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Design & Implementation of a Quality Management System

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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Independent QA Support & Services

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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Inspection Readiness Support

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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