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  • 05 January 2022
  • 35
Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents
On 15 December 2021 the FDA published the draft guidance for industry and FDA staff. Comments may be submitted until 14 February 2022.
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  • 05 January 2022
  • 50
Updated Clinical Trials Information System: Training and Support
On 16 December 2021 the EMA updated the training support for CTIS.
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  • 05 January 2022
  • 40
ICH Guideline Q9 (R1) on Quality Risk Management
On 16 December 2021 the EMA issued the ICH guideline Q9(R1) on quality risk management (step 2b) for public comments. Comments may be submitted until 15 March 2022.
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  • 05 January 2022
  • 36
Inspection of Injectable Products for Visible Particulates
On 17 December 2021 the FDA published the draft guidance for industry. Comments may be submitted until 15 February 2022.
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  • 05 January 2022
  • 65
Guideline for the Notification of Serious Breaches of Regulation (EU) No 536/2014 or the Clinical Trial Protocol
On 17 December 2021 the EMA issued the final guideline for the notification of serious breaches of EU clinical trial regulation 536/2014 or the clinical trial protocol.
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  • 05 January 2022
  • 42
Progressive Roll-out of In Vitro Diagnostic Medical Devices Regulation
On 17 December 2021 the European Commission released the progressive roll-out of in-vitro diagnostic medical device regulations beginning 26 May 2022.
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  • 05 January 2022
  • 43
Clinical Drug Trial Investigator Charged with Insider Trading
On 20 December 2021 the U.S. Securities and Exchange Commission (SEC) disclosed insider trading charges against investigator.
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  • 05 January 2022
  • 116
Clinical Trials on Medicinal Products in Switzerland
On 20 December 2021 the Swissmedic announced the paperless submission as of 1 January 2022.
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  • 05 January 2022
  • 33
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
On 22 December 2021 the FDA published the draft guidance for industry, investigators, and other stakeholders. Comments may be submitted until 22 March 2022.
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  • 05 January 2022
  • 28
Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology
On 22 December 2021 the FDA published the draft guidance for industry and FDA staff. Comments may be submitted until 22 February 2022.
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  • 05 January 2022
  • 36
Innovative Licensing and Access Pathway
On 30 December 2021, the UK MHRA updated the guidance on a new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
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  • 05 January 2022
  • 110
Widler & Schiemann AG Appoints Martin E. Zuzulo as New Managing Director - Americas
PRINCETON, NJ, January 4, 2022 – Widler & Schiemann AG is expanding its presence and portfolio of capabilities with the appointment of Martin E. Zuzulo as Managing Director-Americas.
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  • 20 December 2021
  • 95
Clinical Trials Information System (CTIS) – Sponsor Handbook
On 2 December 2021 the EMA updated the CTIS sponsor handbook: a compilation of key guidance, technical information, recommendations and references for getting ready for use of CTIS.
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  • 20 December 2021
  • 68
Establishment and Operation of Clinical Trial Data Monitoring Committees
On 3 December 2021 the FDA published the final guidance for clinical trial sponsors.
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  • 20 December 2021
  • 73
ICMRA and WHO Map out Flexibilities Used by Regulators to Respond to the COVID-19 Pandemic
On 3 December 2021 the EMA announced the regulatory flexibilities to respond to the COVID-19 pandemic.
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  • 20 December 2021
  • 82
IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations
On 7 December 2021 the FDA published the draft guidance for industry. Comments may be submitted by 7 February 2022.
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  • 20 December 2021
  • 69
IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations
On 7 December 2021 the FDA published the draft guidance for industry. Comments may be submitted until 7 February 2022.
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  • 20 December 2021
  • 83
Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products
On 8 December 2021 the FDA published the draft guidance for industry. Comments may be submitted until 8 March 2022.
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  • 20 December 2021
  • 89
Development of Anti-Infective Drug Products for the Pediatric Population
On 9 December 2021 the FDA published the final guidance for industry.
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  • 20 December 2021
  • 69
CMC Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports
On 9 December 2021 the FDA published the final guidance for industry.
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  • 20 December 2021
  • 65
Substantial Modification of Clinical Investigation under Medical Device Regulation
On 9 December 2021 the European Commission published the medical device coordination group (MDCG) document 2021-28.
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  • 20 December 2021
  • 45
Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
On 9 December 2021 the European Commission published the medical device coordination group (MDCG) Q&A document 2021-27.
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  • 20 December 2021
  • 56
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry
On 10 December 2021 the FDA published the draft guidance for industry. Comments may be submitted until 10 February 2022.
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  • 20 December 2021
  • 68
Q3C(R8) Impurities: Guidance for Residual Solvents
On 10 December 2021 the FDA published the final guidance for industry.
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  • 20 December 2021
  • 86
Highlights from the 16th EMA Industry Platform Meeting on the Operation of EU Pharmacovigilance Legislation
On 10 December 2021 the EMA published highlights from the 16th Pharmacovigilance Industry Platform meeting.
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  • 20 December 2021
  • 66
Global Reflections on International Inspection Transformation: ICMRA Remote Inspections
On 10 December 2021 the MHRA Inspectorate published an article by Paula Walker.
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  • 20 December 2021
  • 48
EU Country Health Profiles
On 13 December 2021 the European Commission released the 2021 edition of country health profiles.
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  • 20 December 2021
  • 59
Clinical Trials Information System (CTIS) Highlights
On 13 December 2021 the EMA published CTIS highlights.
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  • 20 December 2021
  • 84
Adjustments Required for Entering Drug Manufacturers into the EudraGMDP Database
On 14 December 2021 the Swissmedic announced the adaptation for the integration of the EudraGMDP with the organization management service (OMS).
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  • 01 December 2021
  • 123
MHRA Updated Guidance on Managing Clinical Trials during Coronavirus (COVID-19)
On 16 November 2021 the UK MHRA updated the Urgent Safety Measures section of its guidance on managing clinical trials during COVID-19.
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  • 01 December 2021
  • 120
IRIS Guide for Applicants
On 24 November 2021 the EMA updated the IRIS guide for applicants, version 2.4.
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  • 01 December 2021
  • 108
Press Release: ICH Assembly Virtual Meeting, November 2021
On 25 November 2021 the ICH released the ICH assembly virtual meeting on 17 and 18 November.
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  • 01 December 2021
  • 114
EU Commission Implementing Regulation (EU) 2021/2078 re the Application of Regulation (EU) 2017/745 and the European Database on Medical Devices (Eudamed)
On 26 November 2021 the EC laid down rules for the application of Regulation (EU) 2017/745 and the European database on medical devices.
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  • 01 December 2021
  • 121
Annual Report of the Pharmacovigilance Inspectors Working Group (PhV IWG) for 2019 and 2020
On 26 November 2021 the EMA published the annual report of PhV IWG for 2019 and 2020. It was adopted by the PhV IWG on 12 November 2021.
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  • 01 December 2021
  • 153
EMA’s Guide on Advanced Therapy Medicinal Products - Clinical Development
On 29 November 2021 the EMA published the flowchart guide on advanced therapy medicinal products during the clinical development.
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  • 01 December 2021
  • 164
Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
On 29 November 2021 the FDA published the draft guidance for industry. Comments may be submitted by 28 February 2022.
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  • 01 December 2021
  • 129
Updated Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) including Pharmacovigilance System Master Files (PSMF)
On 30 November 2021 the UK MHRA updated the guidance on requesting a UK PSMF number.
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  • 29 November 2021
  • 103
Position Paper by Swissmedic and Swissethics on Decentralized Clinical Trials (DCTs) with Medicinal Products
On 1 November 2021 the Swissmedic issued the updated guidance on DCTs.
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  • 29 November 2021
  • 130
Content of Premarket Submissions for Device Software Functions
On 4 November 2021 the FDA published the draft guidance for Industry and FDA staff. Comments may be submitted by 2 February 2022.
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  • 29 November 2021
  • 126
Good Practice on the Assessment of GMO-Related Aspects in the Context of Clinical Trials with Human Cells Genetically Modified
On 6 November 2021 the European Commission updated the guidance, version 5.
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  • 29 November 2021
  • 99
Common Application Form for Clinical Research with Human Cells Genetically Modified
On 6 November 2021 the European Commission published the updated version of the common application form for clinical research with human cells genetically modified.
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  • 29 November 2021
  • 99
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
On 15 November 2021 the FDA published the updated guidance for Developers and FDA staff.
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  • 29 November 2021
  • 114
Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 15 November 2021 the FDA published the updated guidance for Commercial Manufactures, Clinical Laboratories and FDA staff.
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  • 29 November 2021
  • 146
Good Laboratory Practice (GLP) for Safety Tests on Chemicals
On 15 November 2021 the UK MHRA updated the GLP guidance.
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  • 29 November 2021
  • 105
Updated FAQs: Introduction to the Clinical Trials Regulation (EU) No 536/2014
On 15 November 2021 the EMA published the updated guidance on the FAQs of CTIS training program module 1.
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  • 29 November 2021
  • 96
Updated Instructor’s Guide: Introduction to the Clinical Trials Regulation (EU) No 536/2014
On 15 November 2021 the EMA published the updated guidance on the instructor’s guide of CTIS training program module 1.
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  • 15 November 2021
  • 134
Clinical Trials Information System (CTIS) Highlights
On 18 October 2021 the EMA published CTIS Highlights, Issue 5.
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  • 15 November 2021
  • 186
Guidance on the Electronic Submission of Information on Investigational Medicinal Products for Human Use in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
On 20 October 2021 the EMA published the Extended EudraVigilance Medicinal Product Report (XEVPRM) user guidance for sponsors of clinical trials.
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  • 15 November 2021
  • 129
Data Standards for Drug and Biological Product Submissions Containing Real-World Data
On 21 October 2021 the FDA published the draft guidance for industry. Comments may be submitted until 21 January 2022.
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  • 15 November 2021
  • 137
CMDh Best Practice Guide on Multilingual Packaging
On 22 October 2021 the Coordination Group for Mutual Recognition and Decentralized Procedures—Human (CMDh) updated the best practice guide on multilingual packaging.
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  • 15 November 2021
  • 130
Updated Clinical Trials for Medicines: Manage Your Authorization, Report Safety Issues
On 26 October 2021 the UK MHRA updated the “Apply to change your trial’s protocol or documentation” section of clinical trials for medicines guidance.
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  • 15 November 2021
  • 143
Study Coordinator Pleads Guilty in Scheme to Falsify Clinical Drug Trial Data
On 26 October 2021 the US Department of Justice announced investigation into case of falsifying clinical drug trial data.
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  • 15 November 2021
  • 151
Good Machine Learning Practice for Medical Device Development: Guiding Principles
On 27 October 2021 the FDA, Health Canada, and the UK MHRA jointly issued GMLP guiding principles.
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  • 15 November 2021
  • 134
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide
On 29 October 2021 the FDA published the final guidance for industry.
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  • 15 November 2021
  • 217
Principles for Sponsor Organization Modelling for CTIS
On 29 October 2021 the EMA published the version 2 of the guidebook.
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  • 19 October 2021
  • 170
Good Lay Summary Practice
On 4 October 2021 the European Commission added guidance to Chapter V of EudraLex Volume 10.
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  • 19 October 2021
  • 170
Content and Format of Substantial Equivalence Reports; FDA Actions on Substantial Equivalence Reports
On 5 October 2021 the FDA published the final rule on the content and format of substantial equivalence reports.
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  • 19 October 2021
  • 174
Medical Device De Novo Classification Process
On 5 October 2021 the FDA published the final rule on the medical device De Novo classification process.
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  • 19 October 2021
  • 264
European Union Clinical Trials Information System CTIS: Go-live Planning
On 8 October 2021 the EMA published the summary of key areas in preparation for the CTIS implementation.
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  • 19 October 2021
  • 177
More Than 100 Applications Lost Equivalence Rating Thanks to Allegedly Falsified Data at Two CROs
On 11 October 2021 Informa.com published analysis on the impact of data integrity issues.
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  • 19 October 2021
  • 193
Q13 Continuous Manufacturing of Drug Substances and Drug Products
On 12 October 2021 the FDA published the draft guidance for industry.
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  • 19 October 2021
  • 202
Clinical Trials Information System (CTIS): Virtual Information Day
On 13 October 2021 the EMA announced the CTIS virtual information day taking place on 26 October 2021.
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  • 19 October 2021
  • 186
MA Adopts ICH Guideline E8 (R1) on General Considerations for Clinical Studies
On 14 October 2021 the EMA adopted the ICH guideline E8 (R1), step 5, effective 14 April 2022.
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  • 19 October 2021
  • 178
European Commission Proposes a Progressive Roll-out of the New In Vitro Diagnostic Medical Devices Regulation
On 14 October 2021 the European Commission published a proposal on a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation.
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  • 19 October 2021
  • 188
UK MHRA Updated Guidance on Pharmacovigilance Procedures
On 14 October 2021 the UK MHRA updated the guidance on pharmacovigilance procedures.
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  • 19 October 2021
  • 199
Clinical Trials Regulation (EU) No 536/2014 Draft Questions & Answers
On 14 October 2021 the European Commission published draft Q&A guidance, version 4.1.
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  • 04 October 2021
  • 485
Clinical Trials Information System (CTIS): Virtual Information Day
On 16 September 2021 the EMA announced the virtual CTIS information day on 26 October 2021.
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  • 04 October 2021
  • 245
Q2(R1) Validation of Analytical Procedures: Text and Methodology
On 16 September 2021 the FDA published the final guidance for industry.
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  • 04 October 2021
  • 234
Updated IRIS Guide for Applicants
On 16 September 2021 the EMA updated the IRIS guide on how to create and submit scientific application, for industry and individual applicants.
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  • 04 October 2021
  • 220
Questions and Answers on Biosimilar Development and the BPCI Act
On 17 September 2021 the FDA published the final Q&As guidance for industry.
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  • 04 October 2021
  • 221
Questions and Answers on Quality Related Controlled Correspondence
On 20 September 2021 the FDA published the draft guidance for industry.
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  • 04 October 2021
  • 267
Procedural Advice for Orphan Medicinal Product Designation
On 27 September 2021 the EMA published this guidance for sponsors.
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  • 04 October 2021
  • 317
Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products
On 28 September 2021 the FDA published the draft guidance for industry.
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  • 04 October 2021
  • 215
Electronic Submission Template for Medical Device 510(k) Submissions
On 29 September 2021 the FDA published the draft guidance for industry and FDA staff. Comments should be submitted by 28 November 2021.
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  • 04 October 2021
  • 287
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial
On 29 September 2021 the FDA published the draft guidance for industry.
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  • 04 October 2021
  • 279
Microbiological Quality Considerations in Non-Sterile Drug Manufacturing
On 29 September 2021 the FDA published the draft guidance for industry. Comments should be submitted by 29 November 2021.
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  • 04 October 2021
  • 227
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices
On 29 September 2021 the FDA published the draft guidance for industry. Comments should be submitted by 29 November 2021.
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  • 04 October 2021
  • 208
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations
On 29 September 2021 the FDA published the final guidance for industry.
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  • 04 October 2021
  • 303
Benefit-Risk Assessment for New Drug and Biological Products
On 29 September 2021 the FDA published the draft guidance. Comments should be submitted by 29 November 2021.
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  • 04 October 2021
  • 649
Clinical Trials for Medicines: Apply for Authorization in the UK
On 30 September 2021 the UK MHRA updated the guidance on how to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to the application.
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  • 17 September 2021
  • 267
Targeted Stakeholder Consultation on the Amendments to Commission Implementing Regulation (EU) 520/2012 on Pharmacovigilance Activities
On 1 September 2021 the European Commission announced the targeted stakeholder consultation from 31 August to 15 October 2021.
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  • 17 September 2021
  • 282
UK MHRA and US FDA Tackle Challenging Data Integrity
On 1 September 2021 the UK MHRA Inspectorate published the white paper on 2020 MHRA and FDA joint Good Clinical Practice (GCP) symposium.
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  • 17 September 2021
  • 324
UK MHRA Updated Managing Clinical Trials During Coronavirus (COVID-19)
On 8 September 2021 the UK MHRA updated guidance on managing clinical trials during COVID-19.
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  • 17 September 2021
  • 268
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers
On 8 September 2021 the FDA published the final Q&A guidance for industry.
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  • 17 September 2021
  • 253
S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
On 9 September 2021 the FDA published the ICH S12 draft guidance for industry.
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  • 17 September 2021
  • 312
Technical Workshop on Real-world Metadata for Regulatory Purposes
On 9 September 2021 the EMA published the summary report of the technical workshop that took place on 12 April 2021.
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  • 17 September 2021
  • 460
Webinar for Small and Medium-sized Enterprises (SMEs) and Academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS)
On 10 September 2021 the EMA announced a webinar for SMEs and academia on 29 November 2021.
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  • 17 September 2021
  • 299
Updated Danish Medicines Agency’s Guidance on the Implementation of Decentralized Elements in Clinical Trials with Medicinal Products
On 10 September 2021 the Danish Medicines Agency announced the availability of the updated guidance version 2.0.
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  • 17 September 2021
  • 778
Detailed Guidance on the Electronic Submission of Information on Medicinal Products for Human Use by Marketing Authorization Holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004
On 14 September 2021 the EMA updated the extended EudraVigilance Medicinal Product Report Message (XEVPRM) user guidance.
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  • 17 September 2021
  • 355
Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products - General Principles
On 15 September 2021 the EMA published the EMA-FDA PSA program.
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  • 10 September 2021
  • 349
Guidance for Notified Bodies, Distributors and Importers on Certification Activities in Accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
In August 2021 the Medical Device Coordination Group (MDCG) published guidance of MDCG 2021-23.
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  • 10 September 2021
  • 336
DAIDS Good Clinical Laboratory Practice Guidelines
On 16 August 2021 the Division of AIDS (DAIDS) in the U.S. National Institute of Allergy and Infectious Diseases (NIAID) published the GCLP guidelines.
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  • 10 September 2021
  • 297
General Principles EMA-FDA Parallel Scientific Advice (Human Medicinal Products)
On 18 August 2021 the EMA published updated general principles on EMA-FDA parallel scientific advice.
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  • 10 September 2021
  • 334
Australian Therapeutic Goods Administration (TGA) Reduces Timeframe for Publishing Adverse Event Reports
On 19 August 2021 the TGA announced a reduced timeframe for publishing adverse event reports.
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  • 10 September 2021
  • 285
Notifying FDA of Fatalities Related to Blood Collection or Transfusion
On 20 August 2021 the FDA announced updated guidance for industry.
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  • 10 September 2021
  • 379
FDA Export Certification
On 20 August 2021 the FDA published the final guidance for industry.
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  • 10 September 2021
  • 270
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application
On 20 August 2021 the FDA published the draft guidance for industry.
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  • 10 September 2021
  • 329
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
On 25 August 2021 the FDA published the draft guidance for industry.
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  • 10 September 2021
  • 279
FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
On 30 August 2021 the FDA published updated guidance for industry, investigators, and Institutional Review Boards.
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  • 10 September 2021
  • 226
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
On 31 August 2021 the FDA published the final guidance on technical specifications document for industry.
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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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As recognized experts in QRM we provide leading edge knowledge and support to clients developing and implementing a QRM approach.

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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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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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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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