Open Menu

Navigate Compliance Waters

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.

Our Services

Download as PDF
  • 03 March 2021
  • 596
EMA Updated Q&A: Good Clinical Practice
On 16 February 2021 the EMA updated GCP Q&A by adding a new Q&A (#15) to the GCP Matters section.
Read more online Read
  • 03 March 2021
  • 651
Audit Checklist – Interpretation Guide
On 16 February 2021 the EMA published the first interpretation guide to support the common audit checklist, in cooperation with the members of the joint audit programme.
Read the pdf Read
  • 03 March 2021
  • 691
MHRA Updated Guidance on Managing Clinical Trials during COVID-19
On 17 February 2021 the MHRA updated the guidance by adding a section on the management of COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials.
Read more online Read
  • 03 March 2021
  • 549
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests
On 22 February 2021 the FDA issued initial guidance for test developers and FDA staff.
Read more online Read
  • 03 March 2021
  • 552
Emergency Use Authorization for Vaccines to Prevent COVID-19
On 22 February 2021 the FDA issued additional guidance for industry.
Read more online Read
  • 03 March 2021
  • 503
Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe
On 22 February 2021 the EMA published the new regulatory and procedural guideline on product management services: Chapter 8 – Practical examples.
Read the pdf Read
  • 03 March 2021
  • 3930
Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe: Chapter 3
On 22 February 2021 the EMA published the new regulatory and procedural guideline on product management service: Chapter 3 – Process for the electronic submission of medicinal products information.
Read the pdf Read
  • 03 March 2021
  • 1761
Clinical Trials Regulation (EU) No 536/2014: Questions & Answers
On 24 February 2021 the European Commission released the draft Q&A on EU clinical trials regulation No 536/2014, version 3.
Read the pdf Read
  • 03 March 2021
  • 537
MHRA Pharmacovigilance Inspection Metrics: April 2019 to March 2020
On 26 February 2021 the MHRA GPvP inspectorate published the latest inspection metrics for the period from April 2019 to March 2020.
Read the pdf Read
  • 17 February 2021
  • 6415
Chinese NMPA Released the National Medical Products Newsletter
In January 2021 the Chinese NMPA published 2021 Volume I of the National Medical Products Newsletter.
Read the pdf Read
  • 17 February 2021
  • 618
Draft Toolbox Guidance on Scientific Elements and Regulatory Tools to Support Quality Data Packages for PRIME Marketing Authorization Applications
On 2 February 2021 the EMA published the draft toolbox guidance. Comments should be submitted by 31 July 2021.
Read the pdf Read
  • 17 February 2021
  • 7666
EMA Guideline on Good Pharmacovigilance Practices (GVP) Module XVI Addendum II
On 3 February 2021 the EMA published the draft guideline on GVP Module XVI Addendum II – Methods for Effectiveness Evaluation. Comments should be submitted by 28 April 2021.
Read the pdf Read
  • 17 February 2021
  • 1488
EMA Guideline on Good Pharmacovigilance Practices (GVP) Module XVI
On 3 February 2021 the EMA published the draft guideline on GVP Module XVI – Risk Minimization Measures: Selection of Tools and Effectiveness Indicators (Rev 3). Comments should be submitted by 28 April 2021.
Read the pdf Read
  • 17 February 2021
  • 680
Guidance on the Management of Clinical Trials During the Covid-19 (Coronavirus) Pandemic
On 4 February 2021 the EMA published guidance version 4 with the key changes of remote source data verification.
Read the pdf Read
  • 17 February 2021
  • 6926
Reference Safety Information (RSI) for Clinical Trials – Part III
On 5 February 2021 the MHRA GCP inspectorate published the RSI blog posts Part III.
Read more online Read
  • 17 February 2021
  • 632
EMA Post-authorization Procedural Advice for Users of the Centralized Procedure
On 8 February 2021 the EMA published the post-authorization guidance.
Read the pdf Read
  • 17 February 2021
  • 581
Investigational COVID-19 Convalescent Plasma
On 11 February 2021 the FDA published revised guidance for industry.
Read more online Read
  • 17 February 2021
  • 635
MHRA Guidance on Pharmacovigilance Requirements for UK Authorized Products from 1 January 2021
On 12 February 2021 the guidance was published on the MHRA inspectorate blog.
Read more online Read
  • 17 February 2021
  • 579
GCP Inspections Metrics Report
On 12 February 2021 the MHRA GCP Inspectorate issued the GCP inspections metrics report covering 1 April 2018 to 31 March 2019.
Read the pdf Read
  • 02 February 2021
  • 600
FDA Released Artificial Intelligence/Machine Learning Action Plan
On 12 January 2021 the FDA released the agency’s first artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) action plan.
Read more online Read
  • 02 February 2021
  • 623
Guidelines 01/2021on Examples Regarding Data Breach Notification
On 18 January 2021 the European Data Protection Board announced the notification for public consultation. Comments should be sent by 2 March 2021.
Read the pdf Read
  • 02 February 2021
  • 34318
Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency
On 19 January 2021 the FDA published the final guidance for industry.
Read more online Read
  • 02 February 2021
  • 666
Commission Notice – Application of the Union’s Pharmaceutical Acquis in Markets Historically Dependent on Medicines Supply from or through Great Britain after the End of the Transition Period
On 25 January 2021 the EMA published the European Commission notice to stakeholders.
Read more online Read
  • 02 February 2021
  • 600
Assent / Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe
On 25 January 2021 the European Network of Paediatric Research at the EMA’s (Enpr-EMA’s) Working Group on Ethics developed the guidance.
Read the pdf Read
  • 02 February 2021
  • 654
FDA Updated Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
On 27 January 2021 the FDA updated the final guidance for industry, investigators and institutional review boards.
Read more online Read
  • 02 February 2021
  • 527
Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 28 January 2021 the FDA published the final guidance for industry and FDA staff.
Read more online Read
  • 02 February 2021
  • 681
Overview of Comments Received on 'Draft Questions and Answers on Data Monitoring Committees Issues' (EMA/492010/2018)
On 29 January 2021 the EMA published the overview of comments on draft Q&A on Data Monitoring Committees Issues.
Read the pdf Read
  • 19 January 2021
  • 573
IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations
On 4 January 2021 the FDA announced the availability of the draft guidance for sponsor-investigators. Comments may be submitted until 4 March 2021.
Read more online Read
  • 19 January 2021
  • 644
Human Gene Therapy for Neurodegenerative Diseases
On 5 January 2021 the FDA announced the availability of the draft guidance for industry.
Read more online Read
  • 19 January 2021
  • 535
Safer Technologies Program for Medical Devices
On 6 January 2021 the FDA announced the availability of the final guidance for industry and FDA staff.
Read more online Read
  • 19 January 2021
  • 7003
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
On 6 January 2021 the FDA announced the availability of the final guidance for industry and FDA staff.
Read more online Read
  • 19 January 2021
  • 588
Florida Medical Doctor Pleads Guilty to Conspiring to Falsify Clinical Trial Data
On 8 January 2021 the FDA released press on a sentence of medical doctor falsifying clinical trial data.
Read more online Read
  • 19 January 2021
  • 548
COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity
On 13 January 2021 the FDA published the guidance.
Read more online Read
  • 19 January 2021
  • 588
EMA Procedural Advice for Users of the Centralized Procedure
On 13 January 2021 the EMA updated 3 guidance on pre-/post-authorization procedural advice for users of the centralized procedure or for generic/hybrid applications.
Read more online Read
  • 19 January 2021
  • 495
EMA Updated Guidance on Obtaining and Maintaining a Scientific Opinion on a Medicine for Use Outside the EU
On 14 January 2021 the EMA updated the guidance on promoting parallel application for EU-M4all opinion and centralized marketing authorization procedure.
Read the pdf Read
  • 19 January 2021
  • 1033
EMA Updated Questions & Answers on Signal Management
On 15 January 2021 the EMA published revision 4 of the Q&A on signal management.
Read the pdf Read
  • 19 January 2021
  • 575
Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency
On 15 January 2021 the FDA published the final guidance for industry.
Read more online Read
  • 05 January 2021
  • 709
EMA Updated Guidance on Good Manufacturing Practice and Good Distribution Practice: Questions and Answers
On 16 December 2020 the EMA updated Q&A guidance on GMP and GDP in EU GMP guide part I, chapter 5.
Read more online Read
  • 05 January 2021
  • 6771
EMA Updated Questions and Answers on Labeling Flexibilities for COVID-19 Vaccines
On 16 December 2020 the EMA published the revision 1 of Q&A document on labelling flexibilities for COVID-19 vaccines.
Read the pdf Read
  • 05 January 2021
  • 710
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products
On 16 December 2020 the FDA announced the availability of the final guidance for industry.
Read more online Read
  • 05 January 2021
  • 529
ontrolled Correspondence Related to Generic Drug Development Guidance for Industry
On 16 December 2020 the FDA published the final guidance for industry.
Read more online Read
  • 05 January 2021
  • 554
Dry Eye: Developing Drugs for Treatment
On 16 December 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted until 17 March 2021.
Read more online Read
  • 05 January 2021
  • 563
EMA Updated IRIS Guide for Applicants
On 17 December 2020 the EMA published the updated version 1.9 of IRIS guide for industry and individual applicants.
Read the pdf Read
  • 05 January 2021
  • 6770
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion
On 17 December 2020 the FDA announced the availability of the final guidance for industry.
Read more online Read
  • 05 January 2021
  • 643
EMA Updated Clinical Trials Information System Development
On 18 December 2020 the EMA published the updated clinical trials information system (CTIS) development.
Read more online Read
  • 05 January 2021
  • 628
Procedural Advice for Post-orphan Medicinal Product Designation Activities
On 21 December 2020 the EMA published the guidance for sponsors.
Read the pdf Read
  • 05 January 2021
  • 588
Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency — Guidance for Industry
On 21 December 2020 the FDA announced the availability of the final guidance for industry.
Read more online Read
  • 05 January 2021
  • 556
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers (Revised)
On 22 December 2020 the FDA published the updated Q&A guidance for industry and FDA staff.
Read more online Read
  • 05 January 2021
  • 606
Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling
On 23 December 2020 the FDA published the final guidance for industry.
Read more online Read
  • 05 January 2021
  • 455
MHRA Guidance on Submitting Clinical Trial Safety Reports
On 31 December 2020 the MHRA published the guidance on how to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs).
Read more online Read
  • 05 January 2021
  • 645
Exceptions and Modifications to the EU Guidance on Good Pharmacovigilance Practices that Apply to UK Marketing Authorization Holders and the Licensing Authority
On 31 December 2020 the MHRA published a guidance note on GVP.
Read the pdf Read
  • 05 January 2021
  • 845
MHRA Guidance on Substantial Amendments to a Clinical Trial
On 31 December 2020 the MHRA published guidance on substantial amendments to a clinical trial.
Read more online Read
  • 17 December 2020
  • 733
Requesting FDA Feedback on Combination Products
On 3 December 2020 the FDA Announced the Availability of the Final Guidance for Industry and FDA Staff.
Read more online Read
  • 17 December 2020
  • 609
Update to FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency
On 4 December 2020 the FDA Updated the Final Guidance for Industry, Investigators, and Institutional Review Boards.
Read more online Read
  • 17 December 2020
  • 691
Reflection Paper on Patient-Focused Drug Development for Public Consultation
On 7 December 2020 the ICH Published the Reflection Paper on PFDD for Public Consultation by 7 March 2021.
Read the pdf Read
  • 17 December 2020
  • 810
MHRA Updated Guidance on Regulating Medical Devices from 1 January 2021
On 7 December 2020 the MHRA Updated the Medical Devices Guidance.
Read more online Read
  • 17 December 2020
  • 652
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry
On 8 December 2020 the FDA Announced the Availability of the Draft Guidance for Industry.
Read more online Read
  • 17 December 2020
  • 621
European Medicines Agencies Network Strategy to 2025
On 8 December 2020 the EMA Published the Joint Strategy Setting Direction for EMA and EU Medicines Regulatory Agencies to 2025.
Read the pdf Read
  • 17 December 2020
  • 645
The eCTD v4.0 Q&A v1.4 Reaches Step 4 of the ICH Process
On 9 December 2020 the ICH Announced eCTD v4.0 Reaches Step 4.
Read more online Read
  • 17 December 2020
  • 654
Clinical Trials Information System (CTIS) Highlights – December 2020
On 9 December 2020 the EMA Published Issue 2 of CTIS Highlights.
Read the pdf Read
  • 17 December 2020
  • 569
Best Practices in Developing Proprietary Names for Human Prescription Drug Products
On 9 December 2020 the FDA Announced the Availability of the Final Guidance for Industry.
Read more online Read
  • 17 December 2020
  • 549
Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway
On 11 December 2020 the FDA Issued the Final Guidance for Industry and FDA Staff.
Read more online Read
  • 17 December 2020
  • 610
Questions and Answers to Stakeholders on the Implementation of the Protocol on Ireland / Northern Ireland
On 11 December 2020 the EMA Published Revision 2 of the Q&A Document.
Read the pdf Read
  • 01 December 2020
  • 2965
Remote Pharmacovigilance Inspections of MAHs during a Crisis Situation - Points to Consider
On 18 November 2020 the EMA announced the availability of revision 1 of the guidance adopted by Pharmacovigilance Inspectors Working Group.
Read the pdf Read
  • 01 December 2020
  • 640
Clinical Drug Interaction Studies with Combined Oral Contraceptives
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 22 February 2021.
Read more online Read
  • 01 December 2020
  • 589
Cross Labeling Oncology Drugs in Combination Regimens
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 19 January 2021.
Read more online Read
  • 01 December 2020
  • 621
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 19 January 2021.
Read more online Read
  • 01 December 2020
  • 644
Qualification Process for Drug Development Tools
On 24 November 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
Read more online Read
  • 01 December 2020
  • 587
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
On 24 November 2020 the FDA announced the availability of the final guidance for industry.
Read more online Read
  • 01 December 2020
  • 695
On-site Access to Electronic Health Records by Sponsor Representatives in Clinical Trials
On 26 November 2020 the UK MHRA published the new guidance for Sponsors, CROs and investigator sites.
Read more online Read
  • 01 December 2020
  • 777
Evaluation of Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry
On 30 November 2020 the FDA published the draft guidance for industry. Submit comments by 26 February 2021.
Read more online Read
  • 01 December 2020
  • 644
MHRA Updated Guidance on Pharmacovigilance Procedures
On 30 November 2020 the MHRA updated the guidance on pharmacovigilance procedures.
Read more online Read
  • 17 November 2020
  • 7052
EMA Updated Q&A: Good Clinical Practice (GCP)
On 3 November 2020 the EMA added a new Q&A (#14) to the GCP matters section.
Read more online Read
  • 17 November 2020
  • 631
Joint Guidance of Swissmedic and Swissethics on the Management of Clinical Trials with Medicinal Drug Products in Switzerland during the COVID-19 Pandemic
On 4 November 2020 Swissmedic and swissethics issued version 2.3 of their joint guidance.
Read more online Read
  • 17 November 2020
  • 544
Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices
On 6 November 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
Read more online Read
  • 17 November 2020
  • 655
Drug Trial Snapshots Summary Report – from 2015 to 2019
On 9 November 2020 the FDA announced the availability of a five-year summary and analysis of clinical trials participation and demographics.
Read more online Read
  • 17 November 2020
  • 595
Regulatory Considerations for Microneedling Products
On 9 November 2020 the FDA issued the final guidance for industry and FDA staff.
Read more online Read
  • 17 November 2020
  • 576
Detailed Guide Regarding the EudraVigilance Data Management Activities by the EMA
On 9 November 2020 the EMA announced the availability of the updated guide.
Read the pdf Read
  • 17 November 2020
  • 305
Guidance on Minimizing Disruptions to the Conduct and Integrity of Clinical Trials of Medicines During COVID-19
On 11 November 2020 the UK MHRA issued the guidance.
Read more online Read
  • 17 November 2020
  • 6906
Information on the Member States Requirement for the Nomination of a Pharmacovigilance (PhV) Contact Person at National Level
On 11 November 2020 the EMA PhV Inspectors Working Group (IWG) updated the information on PhV contact person.
Read the pdf Read
  • 17 November 2020
  • 731
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
On 13 November 2020 the FDA issued the final guidance for industry.
Read more online Read
  • 17 November 2020
  • 592
Certificates of Confidentiality
On 13 November 2020 the FDA issued the final guidance for sponsors, sponsor-investigators, researchers, industry, and FDA staff.
Read more online Read
  • 17 November 2020
  • 604
Consideration on Core Requirements for Risk Management Plans of COVID-19 Vaccines —CoreRMP19 Guidance
On 13 November 2020 the EMA issued the new guidance on risk management plans (RMPs) for COVID-19 vaccines.
Read the pdf Read
  • 03 November 2020
  • 713
Technical Requirements for Clinical Development of Overseas-marketed and Domestic-non-marketed Products
On 12 October 2020 the Chinese CDE of NMPA issued notification No. 29 on technical requirements.
Read more online Read
  • 03 November 2020
  • 594
EMA Guidance for Applicants Seeking Scientific Advice and Protocol Assistance
On 19 October 2020 the EMA issued guidance revision 10 addressing a number of questions that users of the scientific advice or protocol assistance procedures may have.
Read the pdf Read
  • 03 November 2020
  • 608
Reflection Paper on the Pharmaceutical Development of Medicines for Use in the Older Population
On 22 October 2020 the EMA issued this reflection paper for medicine developers.
Read the pdf Read
  • 03 November 2020
  • 752
Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) Including Pharmacovigilance System Master Files (PSMF) from 1 January 2021
On 23 October 2020 the MHRA updated guidance on the QPPV and PSMF for UK authorized products.
Read more online Read
  • 03 November 2020
  • 713
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry
On 20 October 2020 the FDA announced the availability of the draft guidance for industry.
Read more online Read
  • 03 November 2020
  • 614
Updated Guidance on Pharmacovigilance (PV) Procedures
On 27 October 2020 the MHRA published the updated guidance on PV procedures.
Read more online Read
  • 03 November 2020
  • 617
Referencing Approved Drug Products in ANDA Submissions
On 27 October 2020 the FDA announced the availability of the final guidance for industry.
Read more online Read
  • 03 November 2020
  • 554
Providing Regulatory Submissions in Electronic Format — Standardized Study Data
On 29 October 2020 the FDA announced the availability of the final guidance for industry.
Read more online Read
  • 21 October 2020
  • 621
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment
On 1 October 2020 the FDA announced the availability of the final guidance for industry.
Read more online Read
  • 21 October 2020
  • 636
EMA Updated the Status of Clinical Trials Information System (CTIS)
On 5 October 2020 the EMA announced that the audit of the clinical trial information system (CTIS) will commence in November 2020.
Read more online Read
  • 21 October 2020
  • 655
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
On 7 October 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted until 7 December 2020.
Read more online Read
  • 21 October 2020
  • 597
MHRA Guidance on the Licensing of Biosimilar Products
On 7 October 2020 the MHRA published the open consultation document.
Read more online Read
  • 21 October 2020
  • 577
Checklist for Annual Updates for Parallel Distribution
On 8 October 2020 the EMA announced the availability of the guidance for industry.
Read the pdf Read
  • 21 October 2020
  • 605
Questions and Answers on Data Monitoring Committees Issues
On 8 October 2020 the EMA published the Q&A document on DMC issues.
Read the pdf Read
  • 21 October 2020
  • 835
Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin
On 15 October 2020 the FDA announced the availability of the draft guidance for industry and FDA staff. Comments may be submitted until 15 December 2020.
Read more online Read
  • 21 October 2020
  • 540
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol
On 15 October 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
Read more online Read
  • 21 October 2020
  • 6671
Testing for Biotin Interference in In Vitro Diagnostic Devices
On 15 October 2020 the FDA announced the availability of the final guidance for industry.
Read more online Read
You can subscribe to the WSQMS Newsletter here!

Services

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.

Read Download as PDF
Quality Risk Management

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

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
Contact

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.

  • Baarerstrasse 75, CH 6300 Zug, Switzerland
  • +41 41 558 9193
  • info@wsqms.com

Recent Facebook Posts
Most Popular
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /