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  • 06 January 2023
  • 74
Expansion of Scope of Temporary Authorizations
1 December 2022 – the Swissmedic published guidance on temporary authorizations.
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  • 06 January 2023
  • 65
Clarification of Terminology for Combination Products (Medicinal Products with a Medical Device Component)
15 December 2022 – the Swissmedic published guidance on clarification of terminology for combination products.
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  • 06 January 2023
  • 67
Updated Swissmedic / Swissethics Position Paper on Decentralized Clinical Trials (DCTs) of Medicinal Products
22 December 2022 – the Swissmedic updated the position paper on decentralized clinical trials of medicinal products.
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  • 06 January 2023
  • 66
Register Medical Devices to Place on the Market
6 December 2022 – the MHRA published updated guidance on the registration of medical devices.
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  • 06 January 2023
  • 57
Medicines: Apply for a Parallel Import License
9 December 2022 – the MHRA published updated guidance on applying for a parallel import license.
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  • 06 January 2023
  • 75
Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards
14 November 2022 – the FDA announced a webinar on 13 January 2023 to discuss standards for reporting ICSRs to FAERS.
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  • 06 January 2023
  • 58
Statistical Approaches to Establishing Bioequivalence
2 December 2022 – the FDA published draft guidance on statistical approaches to establishing bioequivalence for industry.
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  • 06 January 2023
  • 75
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
2 December 2022 – the FDA published the draft guidance on the abbreviated new drug applications (ANDAs) for industry.
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  • 06 January 2023
  • 62
E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials
5 December 2022 – the FDA published final ICH E19 guidance for industry.
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  • 06 January 2023
  • 67
Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer
6 December 2022 – the FDA published final guidance on PK-based criteria to support the approval of alternative dosing regimens for PD-1 or PD-L1 blocking antibodies for treating cancer patients.
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  • 06 January 2023
  • 62
Drug Products Labeled as Homeopathic
7 December 2022 – the FDA published final guidance on homeopathic drug products for FDA staff and industry.
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  • 06 January 2023
  • 73
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
9 December 2022 – the FDA published draft guidance on the VMSR program for industry and FDA staff. Submit comments by 7 February 2023.
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  • 06 January 2023
  • 57
Content of Human Factors Information in Medical Device Marketing Submissions
9 December 2022 – the FDA published the draft guidance on medical device marketing submissions for industry and FDA staff. Submit comments by 9 March 2023.
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  • 06 January 2023
  • 42
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe
14 December 2022 – the FDA published final guidance on failure to respond to an ANDA complete response letter.
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  • 06 January 2023
  • 35
Pulmonary Tuberculosis: Developing Drugs for Treatment
14 December 2022 – the FDA published draft guidance on developing drugs for treatment of pulmonary tuberculosis. Submit Comments by 13 February 2023.
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  • 06 January 2023
  • 85
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
15 December 2022 – the FDA published the draft guidance for industry on circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection.
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  • 06 January 2023
  • 47
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
15 December 2022 – the FDA published final guidance on drug labeling for cardiovascular outcome claims for hypertension.
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  • 06 January 2023
  • 52
M11 Clinical Electronic Structured Harmonized Protocol
21 December 2022 – the FDA published draft guidance on the ICH M11 clinical electronic structured harmonized protocol.
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  • 06 January 2023
  • 49
Controlled Correspondence Related to Generic Drug Development
21 December 2022 – the FDA published draft guidance on controlled correspondence related to generic drug development.
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  • 06 January 2023
  • 47
Manual on Borderline and Classification for Medical Devices under Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices
In December 2022 – the European Commission published version 2 of the manual on borderline and classification for medical devices.
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  • 06 January 2023
  • 58
ICH Guideline E8 (R1) on General Considerations for Clinical Studies
2 December 2022 – the EMA published step 5 of ICH Guideline E8 (R1).
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  • 06 January 2023
  • 79
Human Variations Electronic Application Forms (eAF) (DADI) Go-live Q&A Session
6 December 2022 – the EMA published the Q&A guidance on human variations eAF go-live Q&A session held on 27 October 2022 and 8 November 2022.
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  • 06 January 2023
  • 71
EMA EudraVigilance Registration Documents and Manual
7 December 2022 – the EMA published the updated EudraVigilance registration related documents and manual.
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  • 06 January 2023
  • 31
EMA Human Regulatory Update on Medical Devices
8 December 2022 – the EMA updated guidance on medical devices.
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  • 06 January 2023
  • 72
Joint Audit Program for EEA GMP Inspectorates (JAP)
8 December 2022 – the EMA published revision 3 of the audit notification template for EEA GMP inspectorates (JAP).
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  • 06 January 2023
  • 26
Guidance for Applicants/MAHs Involved in GMP, GCP and GVP Inspections Coordinated by EMA
13 December 2022 – the EMA published version 3.1 of guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA.
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  • 06 January 2023
  • 62
Recommendation Paper on Decentralized Elements in Clinical Trials
13 December 2022 – the European Commission published the recommendation paper on decentralized elements in clinical trials, version 01.
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  • 06 January 2023
  • 45
Functional Specifications for the European Database on Medical Devices (EUDAMED)
14 December 2022 – the European Commission published guidance on functional specifications for EUDAMED.
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  • 06 January 2023
  • 55
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) User Manual
15 December 2022 – the EMA published version 5.8 of the XEVMPD data-entry tool user manual.
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  • 06 January 2023
  • 42
Clinical Pharmacology and Pharmacokinetics: Questions and Answers
16 December 2022 – the EMA published updated Q&A guidance on guideline requirements for parenteral oily solutions.
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  • 06 January 2023
  • 54
Q&A: Good Clinical Practice (GCP)
16 December 2022 – the EMA published updated GCP Q&A guidance.
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  • 06 January 2023
  • 59
Updated IRIS Guide to Registration and RPIs
16 December 2022 – the EMA published updated preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration.
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  • 06 January 2023
  • 39
EU Guideline on Orphan Applications (for Designation and Transfer) - 2022/C 440/02
19 December 2022 – the European Commission published the guideline on orphan applications.
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  • 06 January 2023
  • 31
EMA Clinical Trials Highlights
21 December 2022 – the EMA published Issue 12 of the Clinical Trials Highlights newsletter.
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  • 06 January 2023
  • 63
Clinical Trials Information System (CTIS) – Sponsor Handbook
22 December 2022 – the EMA published version 3.01 of the CTIS sponsor handbook.
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  • 12 December 2022
  • 114
NMPA Announcement on Putting into Use the Electronic Certificates of Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product
31 October 2022 – NMPA announced putting into use the electronic certificates of Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product (No. 95, 2022).
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  • 12 December 2022
  • 127
Regulatory Guidelines for Laboratory Developed Tests (LDTs)
24 November 2022 – Singapore Health Sciences Authority (HSA) issued revision one of its regulatory guidelines for LDTs.
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  • 12 December 2022
  • 113
Public Consultation on ICH Guidelines M11 “Clinical electronic Structured Harmonized Protocol (CeSHarP)” and Q5A(R2) “Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin”
28 November 2022 – Swissmedic launched the public consultation on ICH guidelines M11 and Q5A(R2), with a deadline for comments of 26 February 2023 and 10 February 2023, respectively.
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  • 12 December 2022
  • 92
Changes to the Guidance Document Variations TAM HMV4
4 November 2022 – Swissmedic announced an extended reporting time limit of 60 days that applies to variations without assessment.
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  • 12 December 2022
  • 114
Issue of Export Certificates (Free Sales Certificates) for Medical Devices
8 November 2022 – Swissmedic announced the adaptation of the export certificates ordering process for medical devices beginning 1 January 2023.
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  • 12 December 2022
  • 169
MHRA Process for Approving Manufacturing Authorizations or API Registrations in Relation to Unlicensed Cannabis-Based Products for Medicinal Use (CBPMs)
16 November 2022 – MHRA Inspectorate published the blog on MHRA process for approving unlicensed CBPMs.
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  • 12 December 2022
  • 128
Borderline Products: How to Tell if Your Product is a Medical Device and Which Risk Class Applies
16 November 2022 – MHRA updated guidance on medical device borderline products.
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  • 12 December 2022
  • 138
European Commission (EC) Decision Reliance Procedure (ECDRP)
18 November 2022 – MHRA updated guidance on the EC decision reliance procedure.
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  • 12 December 2022
  • 101
Return to International GMP Inspections
8 November 2022 – MHRA Inspectorate published the blog on return to international GMP inspections.
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  • 12 December 2022
  • 100
Access Consortium Good Manufacturing Practice (GMP) Statement
15 November 2022 – MHRA published access consortium statement on GMP inspections reliance and recognition.
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  • 12 December 2022
  • 105
Enforcement Policy Regarding Investigational New Drug (IND) Requirements for Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies
28 November 2022 – FDA published its policy on IND requirements for FMT use.
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  • 12 December 2022
  • 107
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide
1 November 2022 – FDA published the final Small Entity Compliance guidance on HCT/Ps regulations.
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  • 12 December 2022
  • 97
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
1 November 2022 – FDA published draft Q&A guidance on expanded access to investigational drugs for treatment use. Submit comments by 3 January 2023.
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  • 12 December 2022
  • 99
S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals
2 November 2022 – FDA published S1B(R1) as an addendum to the current ICH S1 guidance for industry.
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  • 12 December 2022
  • 118
Cross Labeling Oncology Drugs in Combination Regimens
2 November 2022 – FDA published final guidance on cross labeling oncology drugs for industry.
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  • 12 December 2022
  • 111
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial
4 November 2022 – FDA published final guidance for studies that evaluate multiple versions of a cellular or gene therapy product.
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  • 12 December 2022
  • 129
M10 Bioanalytical Method Validation and Study Sample Analysis
4 November 2022 – FDA published the final guidance on M10 bioanalytical method validation and study sample analysis.
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  • 12 December 2022
  • 108
Sameness Evaluations in an ANDA — Active Ingredients
8 November 2022 – FDA published draft guidance on sameness evaluations in an ANDA. Submit comments by 8 January 2023.
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  • 12 December 2022
  • 109
Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
10 November 2022 – FDA published draft guidance on Q5A(R2) viral safety evaluation of biotechnology products. Submit comments by 14 January 2023.
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  • 12 December 2022
  • 91
Reflection Paper on Criteria to be Considered for the Evaluation of New Active Substance (NAS) Status of Biological Substances
18 November 2022 – EMA published draft guidance on criteria for the evaluation of NAS status of biological substances for consultation. Comments may be submitted until 31 May 2023.
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  • 12 December 2022
  • 106
Annual Report of the Good Clinical Practice (GCP) Inspectors Working Group (IWG) 2021
21 November 2022 – EMA published the annual report of the GCP IWG 2021.
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  • 12 December 2022
  • 108
IRIS Guide to Registration and RPIs
21 November 2022 – EMA published version 2.10 of the preliminary requirements for all IRIS submissions, including substance and research product identifier registration.
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  • 12 December 2022
  • 99
Guidance for Applicants on Simultaneous National Scientific Advice (SNSA) Phase 2 Pilot (from October 2022) – Optimized Process
21 November 2022 – EMA updated the guidance for SNSA phase 2 pilot.
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  • 12 December 2022
  • 95
ICH Guideline Q3C (R8) on Impurities: Guideline for Residual Solvents
28 November 2022 – EMA updated step 5 of the ICH guideline Q3C(R8) on residual solvents.
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  • 12 December 2022
  • 112
Records of Data Processing Activity (public) Regarding the Processing of Personal Data in the Clinical Trials Information System (CTIS)
28 November 2022 – EMA published updated guidance on CTIS data processing activities.
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  • 12 December 2022
  • 93
Union Guidance on Record Keeping and Archiving of Documents Obtained or Resulting from Pharmacovigilance (PV) Inspections
29 November 2022 – EMA published guidance on record keeping and archiving of documents related to EU PV inspections.
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  • 12 December 2022
  • 86
Clinical Trials Information System (CTIS) - Sponsor Handbook
30 November 2022 – EMA published version 3.0 of the CTIS sponsor handbook.
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  • 12 December 2022
  • 74
European Medicines Agency Pre- and Post-Authorization Procedural Advice for Users of the Centralized Procedure
4 November 2022 – EMA updated guidance on pre- and post-authorization procedural advice for users of the centralized procedure.
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  • 12 December 2022
  • 136
Anonymization of Protected Personal Data and Assessment of Commercially Confidential Information during the Preparation of RMPs
4 November 2022 – EMA updated RMP guidance (main body and annexes 4 & 6) for protected personal data and confidential information.
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  • 12 December 2022
  • 86
Procedural Advice for Orphan Medicinal Product Designation
7 November 2022 – EMA updated guidance on the orphan medicinal product designation for sponsors.
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  • 12 December 2022
  • 80
CTIS Training Program Module 07 Updates
8 November 2022 – EMA updated training module 07 of the CTIS step-by-step guide.
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  • 07 November 2022
  • 164
ICH M11 Draft Guideline Reaches Step 2
On 21 October 2022 the ICH announced the ICH M11 draft guidelines reached step 2 of the ICH process.
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  • 07 November 2022
  • 218
ICH E19 Introductory Training Presentation Available
On 25 October 2022 the ICH announced the E19 introductory training presentation available.
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  • 07 November 2022
  • 230
Software and AI as a Medical Device Change Program
On 17 October 2022 the UK MHRA introduced a roadmap for software and AI as a medical device change program.
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  • 07 November 2022
  • 167
Guidance on Pharmacovigilance Procedures
On 25 October 2022 the UK MHRA published the updated guidance on PV procedures.
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  • 07 November 2022
  • 200
Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials
On 17 October 2022 the FDA published the draft guidance on immune-mediated adverse reactions in cancer immunotherapeutic clinical trials for industry.
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  • 07 November 2022
  • 219
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment
On 17 October 2022 the FDA published the final guidance on acute myeloid leukemia treatment for industry.
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  • 07 November 2022
  • 190
Tissue Agnostic Drug Development in Oncology
On 17 October 2022 the FDA published the draft guidance on tissue agnostic drug development in oncology for industry.
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  • 07 November 2022
  • 174
Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care
On 21 October 2022 the FDA published the draft guidance for industry and FDA staff. Submit comments by 20 December 2022.
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  • 07 November 2022
  • 160
Human Gene Therapy for Neurodegenerative Diseases
On 21 October 2022 the FDA published the final guidance on developing human gene therapy for neurodegenerative diseases.
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  • 07 November 2022
  • 147
Multiple Endpoints in Clinical Trials
On 21 October 2022 the FDA published the final guidance on multiple endpoints in clinical trials for industry.
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  • 07 November 2022
  • 154
Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials
On 31 October 2022 the FDA published the draft guidance on measuring and recording growth and evaluating pubertal development in pediatric clinical trials for industry.
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  • 07 November 2022
  • 157
Quick Guide - Part I & Part II: How to Evaluate a Clinical Trial Application: Assessment and Decision - CTIS Training Program - Module 08
On 24 October 2022 the EMA published the quick guide parts I & II guidance on CTIS training program of module 08, version 1.4.
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  • 07 November 2022
  • 170
ICH Guideline, Clinical Study Protocol Template and Technical Specifications
On 26 October 2022 the EMA published Step 2b of the ICH M11 related guidelines.
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  • 07 November 2022
  • 172
Quick Guide & FAQs: Clinical Study Reports Submission - CTIS Training Program - Module 13
On 28 October 2022 the EMA published Module 13 of the quick guide and FAQs guidance on CTIS training program.
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  • 21 October 2022
  • 158
Swissmedic Inspects Swiss Authorized Representatives (CH-REP)
3 October 2022 — Swissmedic published the report of Swiss authorized representatives (CH-REP) inspections in the first half of 2022 to check implementation of the provisions in the market.
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  • 21 October 2022
  • 194
ICH E19 Guideline Reaches Step 4
4 October 2022 — ICH announced that the ICH E19 guideline reached Step 4 of the ICH process.
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  • 21 October 2022
  • 230
ICH Q5A(R2) Draft Guideline Reaches Step 2
11 October 2022 — ICH announced the ICH Q5A(R2) draft guideline reached Step 2 of the ICH process.
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  • 21 October 2022
  • 165
Export Drugs and Medicines: Special Rules
5 October 2022 — MHRA published guidance on how to get permission to export certain drugs and medicines.
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  • 21 October 2022
  • 185
Exporting Active Substances Manufactured in Great Britain for Use in EEA and Northern Ireland
11 October 2022 — MHRA published guidance on how the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain.
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  • 21 October 2022
  • 199
Apply for Manufacturer or Wholesaler of Medicines Licenses
13 October 2022 — MHRA published guidance on how to apply for manufacturer and wholesale of medicines licenses.
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  • 21 October 2022
  • 211
Medicines: Apply for a Parallel Import License
13 October 2022 — MHRA published the guidance on how to get a parallel import license.
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  • 21 October 2022
  • 246
MORE Registrations - User Reference Guide
4 October 2022 — MHRA published the MORE registration user guide.
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  • 21 October 2022
  • 271
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
3 October 2022 — FDA published the final PMA guidance on effect on FDA review clock and goals under MDUFA for industry and FDA staff.
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  • 21 October 2022
  • 338
Review of Drug Master Files (DMF) in Advance of Certain ANDA Submissions Under GDUFA
3 October 2022 — FDA published the draft guidance on Type II API DMFs under GDUFA for industry.
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  • 21 October 2022
  • 211
Facility Readiness: Goal Date Decisions Under GDUFA
3 October 2022 — FDA published industry draft guidance on facility readiness for inspection under GDUFA. Submit comments by 6 December 2022.
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  • 21 October 2022
  • 320
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
3 October 2022 — FDA published final guidance on physical attributes of generic tablets and capsules for industry.
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  • 21 October 2022
  • 185
User Fees and Refunds for Premarket Approval Applications (PMAs) and Device Biologics License Applications (BLAs)
5 October 2022 — FDA published the final guidance on user fees and refunds for PMAs and device BLAs for industry and FDA staff.
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  • 21 October 2022
  • 288
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments (GDUFA)
5 October 2022 — FDA published final guidance on IRs and discipline review letters under GDUFA.
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  • 21 October 2022
  • 343
Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA
5 October 2022 — FDA published the final guidance on formal meetings between FDA and ANDA applicants for industry.
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  • 21 October 2022
  • 271
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
5 October 2022 — FDA published final guidance on formal meetings between FDA and ANDA applicants of complex products under generic drug user fee amendments (GDUFA) for industry.
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  • 21 October 2022
  • 172
Competitive Generic Therapies
5 October 2022 — FDA published final guidance on competitive generic therapies for industry.
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  • 21 October 2022
  • 206
Post Market Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
6 October 2022 — FDA published the final post market surveillance guidance for industry and FDA staff.
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  • 21 October 2022
  • 255
Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order
7 October 2022 — FDA published the final PAS guidance for industry and FDA staff.
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  • 21 October 2022
  • 271
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA
13 October 2022 — FDA published final guidance on comparability protocols for postapproval CMC changes.
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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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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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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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