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  • 01 April 2022
  • 271
Clinical Trials in Human Medicines: Management of Clinical Trials Impacted by the War in Ukraine
On 31 March 2022 the FDA published the advice to sponsors on management of clinical trials impacted by the war in Ukraine.
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  • 21 March 2022
  • 288
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
On 1 March 2022 the FDA published the final guidance for industry.
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  • 21 March 2022
  • 275
Pre-Launch Activities Importation Requests (PLAIR)
On 1 March 2022 the FDA published the final guidance on the PLAIR for industry.
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  • 21 March 2022
  • 252
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics
On 1 March 2022 the FDA published the final guidance for industry.
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  • 21 March 2022
  • 227
Inclusion of Older Adults in Cancer Clinical Trials
On 2 March 2022 the FDA published the final guidance for industry.
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  • 21 March 2022
  • 279
Unique Identification Number (CHRN – Swiss Single Registration Number)
On 3 March 2022 the Swissmedic updated the guidance on the unique Swiss Single Registration Number for medical devices.
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  • 21 March 2022
  • 276
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
On 9 March 2022 the FDA published draft guidance for industry. Comments may be submitted until 9 May 2022.
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  • 21 March 2022
  • 290
Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions
On 11 March 2022 the FDA published the final guidance for industry.
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  • 21 March 2022
  • 304
Compliance Monitor Process (Part 1) – An Introduction
On 11 March 2022 the MHRA Inspectorate Blog published part one of a two-part series on the Compliance Monitor Process.
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  • 21 March 2022
  • 249
Updated Guidelines on Good Pharmacovigilance Practices (GVP)
On 14 March 2022 the EMA issued an introductory cover note updating the release of Addendum III of Module XVI on pregnancy prevention programs for public consultation.
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  • 21 March 2022
  • 281
Human Gene Therapy Products Incorporating Human Genome Editing
On 15 March 2022 the FDA published draft guidance for industry.
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  • 21 March 2022
  • 337
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
On 15 March 2022 the FDA published draft guidance for industry.
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  • 21 March 2022
  • 276
EudraVigilance – EVWEB User Manual
On 15 March 2022 the EMA updated section 5.1 of the EVWEB reporting tool user manual.
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  • 21 March 2022
  • 267
Updated EMA Q&A: Good Clinical Practice (GCP)
On 15 March 2022 the EMA updated the GCP Q&A guidance.
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  • 04 March 2022
  • 272
Updated Clinical Pharmacology and Pharmacokinetics: Questions and Answers
On 16 February 2022 the EMA published updated Q&A guidance on expectations for bootstrapping to calculate the 90% confidence interval for the f2 similarity factor.
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  • 04 March 2022
  • 413
Eudralex Volume 4 – EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
On 21 February 2022 the European Commission published Annex 21 of Eudralex Volume 4 EU guideline for GMP.
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  • 04 March 2022
  • 274
FDA Issues Proposal to Amend Medical Device Quality System Regulations
On 23 February 2022 the FDA issued an amendment proposal for medical device regulation. Comments on the proposed rule may be submitted until 24 May 2022. Comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 are accepted until 25 March 2022.
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  • 04 March 2022
  • 278
Updated EudraVigilance – EVWEB User Manual
On 23 February 2022 the EMA published version 1.6 of the EVWEB web reporting tool.
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  • 04 March 2022
  • 258
European Medicines Agency Guidance for Applicants Seeking Scientific Advice and Protocol Assistance
On 24 February 2022 the EMA published the updated guidance for scientific advice or protocol assistance procedures.
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  • 04 March 2022
  • 267
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients
On 25 February 2022 the FDA published the final guidance for Industry, FDA staff and other stakeholders.
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  • 04 March 2022
  • 321
NMPA Guidance on Preparation of Pharmacovigilance
On 25 February 2022 the Center for Drug Reevaluation of Chinese NMPA published the notification on PSMF preparation guidance.
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  • 04 March 2022
  • 298
Procedural Advice – Extended Assessment Time for Initial Marketing Authorization Applications of 90 Days
On 25 February 2022 the EMA published the extended assessment time for initial marketing authorization applications.
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  • 22 February 2022
  • 439
Updated Questions and Answers Document – Clinical Trials Regulation (EU) 536/2014
On 1 February 2022 the European Commission published version 5 (January 2022) of the updated Q&A guidance on the Clinical Trials Regulation.
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  • 22 February 2022
  • 407
Clinical Trials Information System (CTIS): Updated Online Modular Training Program
On 3 February 2022 the EMA announced the availability of version 1.1 of online modular CTIS training program.
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  • 22 February 2022
  • 298
EudraVigilance: Obtaining EDQM terms from SPOR
On 3 February 2022 the EMA published the EudraVigilance guidance on obtaining EDQM terms from SPOR.
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  • 22 February 2022
  • 341
Mandatory Use of ISO ICSR/ICH E2B(R3) and EDQM Terminology for Dosage Forms (DF) and Routes of Administration (RoA)
On 3 February 2022 the EMA published guidance on the mandatory use of ISO ICSR/ICH E2B(R3) and EDQM Terminology for DF and RoA.
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  • 22 February 2022
  • 401
Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling–Content and Format
On 3 February 2022 the FDA published the draft guidance for industry. Comments accepted until 5 April 2022.
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  • 22 February 2022
  • 333
Assessment of Pressor Effects of Drugs
On 3 February 2022 the FDA published the draft guidance for industry.
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  • 22 February 2022
  • 506
Population Pharmacokinetics
On 3 February 2022 the FDA published the final guidance for industry.
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  • 22 February 2022
  • 322
Drug Product Tracing: The Effect of Section 585 of the FD&C Act
On 3 February 2022 the FDA published the final guidance on the Q&A.
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  • 22 February 2022
  • 279
Updated Reflection Paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials, with Particular Emphasis on the Handling of Expiry Dates
On 4 February 2022 the EMA announced the new version of the reflection paper on the use of IRTs in clinical trials.
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  • 22 February 2022
  • 295
Update – Guideline on the Requirements to Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials
On 4 February 2022 the European Commission announced the revision 2 on the requirements for quality documentation of chemical and pharmaceutical IMPs in clinical trials.
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  • 22 February 2022
  • 259
Update – Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
On 4 February 2022 the European Commission announced revision 2 on the requirements for quality documentation of biological IMPs in clinical trials.
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  • 22 February 2022
  • 317
Clinical Pharmacology Considerations for Antibody-Drug Conjugates
On 7 February 2022 the FDA published the draft guidance. Comments accepted through 6 May 2022.
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  • 22 February 2022
  • 289
Exporting Active Substances Manufactured in Great Britain for Use in EEA and Northern Ireland
On 7 February 2022 the MHRA updated guidance on how to implement the ‘Written Confirmation’ process for active substances manufactured in Great Britain.
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  • 22 February 2022
  • 302
Clinical Trials for Medicines: Manage your Authorization, Report Safety Issues
On 7 February 2022 the MHRA updated the guidance on managing the clinical trial authorization, reporting safety issues and completing the end-of-trial study report.
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  • 22 February 2022
  • 268
Joint Implementation and Preparedness Plan for Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)
On 7 February 2022 the European Commission announced an update of the joint implementation plan for IVDR.
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  • 22 February 2022
  • 316
Updated IRIS Guide for Applicants
On 7 February 2022 the EMA issued version 2.6 of the IRIS guide for applicants.
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  • 22 February 2022
  • 245
Initiation of DARWIN EU® Coordination Centre Advances Integration of Real-World Evidence into Assessment of Medicines in the EU
On 9 February 2022 the EMA announced the establishment of the Coordination Centre with Erasmus University Medical Center Rotterdam for the DARWIN EU.
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  • 22 February 2022
  • 309
Updated Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic
On 10 February 2022 the European Commission announced the updated guidance on the clinical trials management during the COVID-19 pandemic in Europa.
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  • 22 February 2022
  • 363
Update to Guidance Document: Risk Management Plan (RMP) ICH E2E Information for HMP Submission
On 15 February 2022 the Swissmedic announced the updated guidance on RMP ICH E2E submission information for human medicinal products.
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  • 22 February 2022
  • 387
Big Data Highlights – Issue 1
On 15 February 2022 the EMA published the first edition of the newsletter on Big Data.
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  • 22 February 2022
  • 302
EudraVigilance: Updated Electronic Reporting
On 15 February 2022 the EMA announced an update to electronic reporting in EudraVigilance.
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  • 02 February 2022
  • 379
Clinical Trials Information System (CTIS) Sponsor End User Training Program – March 2022
On 18 January 2022 the EMA announced the CTIS sponsor end user training program being held from 1 March to 4 March 2022, for the new way of submitting, managing and reporting a clinical trial via the CTIS.
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  • 02 February 2022
  • 329
Electronic Application Form (eAF) and Cover Letter Tool
On 20 January 2022 the MHRA updated the guidance on how to complete the eAF and cover letter.
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  • 02 February 2022
  • 346
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
On 21 January 2022 the FDA published the draft guidance for industry, investigators, and other stakeholders. Comments may be submitted until 22 March 2022.
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  • 02 February 2022
  • 385
Regulatory Harmonization of Clinical Trials in the EU: Clinical Trials Regulation to Enter into Application and new Clinical Trials Information System (CTIS) to be Launched
On 25 January 2022 the EMA released the news about the CTIS launching on 31 January 2022.
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  • 02 February 2022
  • 336
Revising ANDA Labeling Following Revision of the RLD Labeling
On 25 January 2022 the FDA published the draft guidance for industry. Comments may be submitted until 25 March 2022.
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  • 02 February 2022
  • 469
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies
On 26 January 2022 the FDA issued the final guidance for industry, FDA staff, and other stakeholders.
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  • 02 February 2022
  • 362
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
On 26 January 2022 the FDA issued the final guidance for industry, FDA staff, and other stakeholders.
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  • 02 February 2022
  • 348
Principles of Premarket Pathways for Combination Products
On 26 January 2022 the FDA issued the final guidance for industry and FDA staff.
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  • 02 February 2022
  • 386
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments
On 26 January 2022 the FDA issued the final guidance for industry.
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  • 02 February 2022
  • 326
Good ANDA Submission Practices
On 26 January 2022 the FDA issued the final guidance for industry.
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  • 02 February 2022
  • 375
Oversight and Monitoring of Investigational Medical Product (IMP) Trials
On 28 January 2022 the MHRA issued guidance to assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of IMPs.
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  • 02 February 2022
  • 287
Risk-Adapted Approach to Clinical Trials and Risk Assessments
On 28 January 2022 the MHRA issued guidance on how to implement a dual strategy for a risk-adapted approach to clinical trials in the UK.
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  • 02 February 2022
  • 298
Guideline on Requirements for Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products (IMPs) in Clinical Trials
On 28 January 2022 the EMA published guidance to define harmonized requirements for documentation submitted throughout the EU.
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  • 19 January 2022
  • 580
Regulating Medical Devices in the UK
On 1 January 2022 the MHRA updated this guidance to reflect changes to the new medical device regulatory requirements.
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  • 19 January 2022
  • 362
Notify the MHRA about a Clinical Investigation for a Medical Device
On 4 January 2022 the MHRA updated the guidance on how to inform them of a clinical investigation of medical devices.
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  • 19 January 2022
  • 338
Investigational COVID-19 Convalescent Plasma
On 7 January 2022 the FDA published the final guidance for industry.
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  • 19 January 2022
  • 367
Clinical Trials for Medicines: How to Apply for Authorization in the UK
On 7 January 2022 the MHRA updated the guidance on the new combined review service.
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  • 19 January 2022
  • 317
European Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 for Safety Assessment of Clinical Trials
On 10 January 2022 the EC released guidance on implementing the EU clinical trial regulation for Safety Assessment in Clinical Trials.
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  • 19 January 2022
  • 380
Accelerating Clinical Trials in the EU (ACT EU)
On 13 January 2022 the EMA launched an EU clinical trials transformation initiative.
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  • 19 January 2022
  • 363
EMA EudraVigilance Registration Manual
On 14 January 2022 the EMA updated the EudraVigilance registration manual.
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  • 19 January 2022
  • 462
Clinical Trials Information System (CTIS) Sponsor User Training Program - January 2022
On 14 January 2022 the EMA announced the CTIS sponsor user training program.
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  • 05 January 2022
  • 319
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
  • 418
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
  • 390
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
  • 359
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
  • 510
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
  • 335
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
  • 355
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
  • 429
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
  • 312
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
  • 303
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
  • 385
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
  • 412
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
  • 444
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
  • 344
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
  • 310
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
  • 349
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
  • 343
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
  • 329
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
  • 357
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
  • 334
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
  • 337
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
  • 320
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
  • 326
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
  • 384
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
  • 414
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
  • 293
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
  • 360
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
  • 382
Clinical Trials Information System (CTIS) Highlights
On 13 December 2021 the EMA published CTIS highlights.
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  • 20 December 2021
  • 330
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
  • 421
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
  • 412
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
  • 370
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
  • 339
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
  • 366
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
  • 476
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
  • 435
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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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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