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
  • 07 November 2022
  • 68
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.
Read more online Read
  • 07 November 2022
  • 97
ICH E19 Introductory Training Presentation Available
On 25 October 2022 the ICH announced the E19 introductory training presentation available.
Read more online Read
  • 07 November 2022
  • 131
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.
Read more online Read
  • 07 November 2022
  • 82
Guidance on Pharmacovigilance Procedures
On 25 October 2022 the UK MHRA published the updated guidance on PV procedures.
Read more online Read
  • 07 November 2022
  • 87
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On 17 October 2022 the FDA published the draft guidance on immune-mediated adverse reactions in cancer immunotherapeutic clinical trials for industry.
Read more online Read
  • 07 November 2022
  • 132
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.
Read more online Read
  • 07 November 2022
  • 91
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On 17 October 2022 the FDA published the draft guidance on tissue agnostic drug development in oncology for industry.
Read more online Read
  • 07 November 2022
  • 74
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On 21 October 2022 the FDA published the draft guidance for industry and FDA staff.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.
Read more online Read
  • 07 November 2022
  • 69
Human Gene Therapy for Neurodegenerative Diseases
On 21 October 2022 the FDA published the final guidance on developing human gene therapy for neurodegenerative diseases.
Read more online Read
  • 07 November 2022
  • 54
Multiple Endpoints in Clinical Trials
On 21 October 2022 the FDA published the final guidance on multiple endpoints in clinical trials for industry.
Read more online Read
  • 07 November 2022
  • 81
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.
Read more online Read
  • 07 November 2022
  • 89
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.
Read
  • 07 November 2022
  • 82
ICH Guideline, Clinical Study Protocol Template and Technical Specifications
On 26 October 2022 the EMA published Step 2b of the ICH M11 related guidelines.
Read more online Read
  • 07 November 2022
  • 78
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.
Read
  • 21 October 2022
  • 89
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.
Read more online Read
  • 21 October 2022
  • 102
ICH E19 Guideline Reaches Step 4
4 October 2022 — ICH announced that the ICH E19 guideline reached Step 4 of the ICH process.
Read more online Read
  • 21 October 2022
  • 126
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.
Read more online Read
  • 21 October 2022
  • 96
Export Drugs and Medicines: Special Rules
5 October 2022 — MHRA published guidance on how to get permission to export certain drugs and medicines.
Read more online Read
  • 21 October 2022
  • 112
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.
Read more online Read
  • 21 October 2022
  • 99
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.
Read more online Read
  • 21 October 2022
  • 114
Medicines: Apply for a Parallel Import License
13 October 2022 — MHRA published the guidance on how to get a parallel import license.
Read more online Read
  • 21 October 2022
  • 165
MORE Registrations - User Reference Guide
4 October 2022 — MHRA published the MORE registration user guide.
Read more online Read
  • 21 October 2022
  • 170
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.
Read more online Read
  • 21 October 2022
  • 218
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.
Read more online Read
  • 21 October 2022
  • 142
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.
Read more online Read
  • 21 October 2022
  • 191
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.
Read more online Read
  • 21 October 2022
  • 104
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.
Read more online Read
  • 21 October 2022
  • 164
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.
Read more online Read
  • 21 October 2022
  • 185
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.
Read more online Read
  • 21 October 2022
  • 145
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.
Read more online Read
  • 21 October 2022
  • 107
Competitive Generic Therapies
5 October 2022 — FDA published final guidance on competitive generic therapies for industry.
Read more online Read
  • 21 October 2022
  • 108
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.
Read more online Read
  • 21 October 2022
  • 119
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.
Read more online Read
  • 21 October 2022
  • 150
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.
Read more online Read
  • 21 October 2022
  • 104
ANDA Submissions – Prior Approval Supplements Under GDUFA
14 October 2022 — FDA published final guidance on ADNA submissions for industry.
Read more online Read
  • 21 October 2022
  • 109
IRIS Guide for Parallel Distribution Applicants
3 October 2022 — EMA published the updated IRIS guide for parallel distribution applicants.
Read the pdf Read
  • 21 October 2022
  • 210
Presentation – Clinical Trials Information System (CTIS) Bitesize Talk (Notifications - Part 1)
3 October 2022 — EMA published part 1 of the recent CTIS bitesize talk presentation.
Read the pdf Read
  • 21 October 2022
  • 101
FAQs: How to Evaluate a CTA – CTIS Training Program Module 06
5 October 2022 — EMA published version 1.4 FAQs on how to evaluate a CTA.
Read the pdf Read
  • 21 October 2022
  • 102
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
5 October 2022 — EMA published the updated reflection paper on the use of IRT.
Read the pdf Read
  • 21 October 2022
  • 102
ICH Guideline S1B(R1) on Testing for Carcinogenicity of Pharmaceuticals
10 October 2022 — EMA published the ICH guideline S1B1(R1) – Step 5.
Read the pdf Read
  • 21 October 2022
  • 161
Data Quality Framework for EU Medicines Regulation
10 October 2022 — EMA published the draft data quality framework for the public consultation until 18 November 2022.
Read the pdf Read
  • 21 October 2022
  • 110
Updated Q&A: Good Clinical Practice (GCP)
10 October 2022 — EMA published updated Q&A guidance on GCP.
Read more online Read
  • 21 October 2022
  • 110
IRIS Guide for Applicants
10 October 2022 — EMA published version 2.13 of the IRIS guide for applicants.
Read the pdf Read
  • 21 October 2022
  • 141
EMA Account Management Training Session Presentation
11 October 2022 — EMA published the presentation shown at the account management training session.
Read the pdf Read
  • 21 October 2022
  • 118
EMA IRIS Industry Training for GVP Inspections: Questions & Answers
11 October 2022 — EMA published the Q&A guidance on IRIS industry training for GVP inspections.
Read the pdf Read
  • 21 October 2022
  • 122
Digital Application Dataset Integration (DADI) eAF Training Webinars (26 July 2022 & 2 September 2022): Questions and Answers
12 October 2022 — EMA published the Q&A guidance on the recent DADI eAF webinars
Read the pdf Read
  • 21 October 2022
  • 171
European Medicines Agency Guidance for Applicants Seeking Scientific Advice and Protocol Assistance
14 October 2022 — EMA published rev. 14 guidance for applicants seeking scientific advice and protocol assistance.
Read the pdf Read
  • 04 October 2022
  • 187
Questions and Answers on Labeling Flexibilities for COVID-19 Vaccines
On 16 September 2022 the EMA published the Q&A guidance on labeling flexibilities for COVID-19 vaccines.
Read the pdf Read
  • 04 October 2022
  • 134
Concept Paper on the Establishment of a Guideline on the Development and Manufacture of Synthetic Oligonucleotides
On 16 September 2022 the EMA published the draft guidance for consultation from 20 September 2022 to 20 December 2022.
Read the pdf Read
  • 04 October 2022
  • 123
The Northern Ireland MHRA Authorized Route (NIMAR)
On 20 September 2022 the MHRA published the updated NIMAR guidance.
Read more online Read
  • 04 October 2022
  • 190
Notify the MHRA about a Clinical Investigation for a Medical Device
On 21 September 2022 the MHRA published the updated guidance on notification of clinical investigation for medical devices.
Read more online Read
  • 04 October 2022
  • 131
How to Obtain a Covered Product Authorization
On 21 September 2022 the FDA published the draft guidance for industry. Submit comments by 21 November 2022.
Read more online Read
  • 04 October 2022
  • 130
Electronic Submission Template for Medical Device 510(k) Submissions
On 22 September 2022 the FDA published the final guidance for industry and FDA staff.
Read more online Read
  • 04 October 2022
  • 184
IRIS Guide for Applicants
On 23 September 2022 the EMA published version 2.12 of the IRIS guide on how to create and submit scientific applications, for industry and individual applicants.
Read the pdf Read
  • 04 October 2022
  • 127
FAQs: How to Create, Submit and Withdraw a Clinical Trial Application — CTIS Training Program - Module 10
On 23 September 2022 the EMA published version 1.3 of the updated FAQs guidance on how to create, submit and withdraw a clinical trial application.
Read the pdf Read
  • 04 October 2022
  • 129
Ethical Considerations for Clinical Investigations of Medical Products Involving Children
On 26 September 2022 the FDA published the draft guidance for industry, sponsors and IRBs.
Read more online Read
  • 04 October 2022
  • 132
Update - EudraLex - Volume 10 - Clinical trials guidelines - Questions and Answers Document - Regulation (EU) 536/2014 – Version 6.2 (September 2022)
On 26 September 2022 the European Commission published the updated Q&A document on clinical trials regulation EU 536/2014, version 6.2.
Read more online Read
  • 04 October 2022
  • 124
Good Clinical Practice for Clinical Trials
On 27 September 2022 the MHRA published the updated guidance on GCP for clinical trials.
Read more online Read
  • 04 October 2022
  • 184
Providing Over-the-Counter Monograph Submissions in Electronic Format
On 27 September 2022 the FDA published the draft guidance. Submit comments by 28 November 2022.
Read more online Read
  • 04 October 2022
  • 121
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
On 27 September 2022 the FDA published updated guidance for developers and FDA staff.
Read more online Read
  • 04 October 2022
  • 280
Checking Process of Mock-Ups and Specimens of Outer/Immediate Labeling and Package Leaflets of Human Medicinal Products in the Centralized Procedure
On 28 September 2022 the EMA published the guidance on checking process of mock-ups and specimens.
Read the pdf Read
  • 04 October 2022
  • 124
Policy for Device Software Functions and Mobile Medical Applications
On 28 September 2022 the FDA published the final guidance on the regulatory oversight to certain software for industry and FDA staff.
Read more online Read
  • 04 October 2022
  • 155
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
On 28 September 2022 the FDA published the final guidance on regulatory oversight to certain medical devices for industry and FDA staff.
Read more online Read
  • 04 October 2022
  • 130
Display Devices for Diagnostic Radiology
On 28 September 2022 the FDA published the final guidance on premarket notification submissions for display devices for industry and FDA staff.
Read more online Read
  • 04 October 2022
  • 127
Clinical Decision Support Software
On 28 September 2022 the FDA published the final guidance on the scope of oversight of clinical decision support software.
Read more online Read
  • 04 October 2022
  • 115
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions
On 28 September 2022 the FDA published final guidance for industry and FDA staff.
Read more online Read
  • 04 October 2022
  • 121
Procedural Advice for Post-Orphan Medicinal Product Designation Activities
On 30 September 2022 the EMA published revision 13 on guidance for post-orphan designated products for sponsors.
Read the pdf Read
  • 21 September 2022
  • 165
Manual on Borderline and Classification for Medical Devices under Regulation (EU)
In September 2022 the European Commission published version 1 of the manual on borderline and classification for medical devices.
Read the pdf Read
  • 21 September 2022
  • 149
Accelerating Clinical Trials in the EU (ACT EU) Multi-Annual Workplan 2022-2026
On 2 September the EMA published the updated ACT EU multi-annual workplan.
Read the pdf Read
  • 21 September 2022
  • 193
Swissmedic Online Information Event: New Regulations on In Vitro Diagnostic Medical Devices
On 5 September Swissmedic announced an online information event for new regulations on in vitro diagnostic medical devices.
Read more online Read
  • 21 September 2022
  • 137
Updated IRIS Guide for Applicants
On 5 September the EMA published version 2.12 of the IRIS guide on how to create and submit scientific applications, for industry and individual applicants.
Read the pdf Read
  • 21 September 2022
  • 154
General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products
On 7 September 2022 the FDA published draft guidance on clinical pharmacology considerations for pediatric studies.
Read more online Read
  • 21 September 2022
  • 134
EMA IRIS Industry Training for GVP Inspections
On 8 September the EMA published their online training sessions of IRIS for GCP inspections.
Read the pdf Read
  • 21 September 2022
  • 149
Medical Devices: Software Applications (Apps)
On 8 September 2022 the MHRA published updated guidance on software apps as medical devices.
Read more online Read
  • 21 September 2022
  • 147
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
On 8 September 2022 the FDA published the final guidance on real-world data and real-world evidence.
Read more online Read
  • 21 September 2022
  • 167
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products
On 8 September 2022 the FDA published the draft guidance on quantitative labeling. Submit comments by 8 November 2022.
Read more online Read
  • 21 September 2022
  • 127
Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products
On 8 September 2022 the FDA published draft guidance on content and format of labeling for human nonprescription drug products. Submit comments by 8 November 2022.
Read more online Read
  • 21 September 2022
  • 135
Certificates of Free Sale to Danish Manufacturers of Medical Devices
On 12 September 2022 the Danish Medicines Agency updated the medical devices guidance on certificates of free sale.
Read more online Read
  • 21 September 2022
  • 134
Policy for Monkeypox Tests to Address the Public Health Emergency
On 13 September 2022 the FDA published final guidance on monkeypox tests for laboratories, commercial manufacturers and FDA staff.
Read more online Read
  • 21 September 2022
  • 131
Computer Software Assurance for Production and Quality System Software
On 13 September 2022 the FDA published draft guidance on computer software assurance for industry and FDA staff. Submit comments by 14 November 2022.
Read more online Read
  • 21 September 2022
  • 151
Q3D(R2) – Guideline for Elemental Impurities
On 14 September 2022 the FDA published draft guidance on elemental impurities.
Read more online Read
  • 05 September 2022
  • 172
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
On 17 August 2022 FDA issued final guidance for industry and FDA staff.
Read more online Read
  • 05 September 2022
  • 202
A Regulatory Pharmaceutical Quality Knowledge Management System (PQKMS) to Enhance the Availability of Quality Medicines
On 17 August 2022 ICMRA (International Coalition of Medicines Regulatory Authorities) published a joint reflection paper in support of the regulatory PQ KMS.
Read more online Read
  • 05 September 2022
  • 192
Charging for Investigational Drugs Under an IND – Questions and Answers
On 23 August 2022 FDA published revised draft Q&A guidance. Submit comments by 24 October 2022.
Read more online Read
  • 05 September 2022
  • 273
Information Event “Regulatory & Beyond”
On 22 August 2022 Swissmedic announced a hybrid information event “Regulatory & Beyond” to be held on 20 September 2022 in Bern.
Read more online Read
  • 05 September 2022
  • 183
Innovation, Quality & Transparency – a Compliance Team 1 Perspective
On 23 August 2022 UK MHRA Inspectorate published a blog on Compliance Matters.
Read more online Read
  • 05 September 2022
  • 182
EMA EudraVigilance Registration Manual
On 23 August 2022 EMA published the updated EudraVigilance registration manual.
Read the pdf Read
  • 05 September 2022
  • 180
Sponsors’ Guide: Transitional Trials from EudraCT to CTIS (sponsor users)
On 24 August 2022 EMA published the CTIS training program, module 23, version 1.2.
Read the pdf Read
  • 05 September 2022
  • 179
FAQs: Transitional Trials from EudraCT to CTIS
On 24 August 2022 EMA published the CTIS training program, module 23, version 1.2.
Read the pdf Read
  • 05 September 2022
  • 184
Revision – Manufacture of Sterile Medicinal Products
On 25 August 2022 the European Commission published the revised guideline for GMP in the EudraLex Volume 4, annex 1.
Read more online Read
  • 05 September 2022
  • 174
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential – Questions and Answers
On 26 August 2022 the FDA published final Q&A guidance on ICH E14 and S7B.
Read more online Read
  • 05 September 2022
  • 232
Q2(R2) Validation of Analytical Procedures
On 26 August 2022 the FDA published draft guidance on ICH Q2(R2).
Read more online Read
  • 05 September 2022
  • 175
Q14 Analytical Procedure Development
On 26 August 2022 the FDA published draft guidance on ICH Q14.
Read more online Read
  • 05 September 2022
  • 188
M12 Drug Interaction Studies
On 26 August 2022 the FDA published draft guidance on ICH M12.
Read more online Read
  • 05 September 2022
  • 186
E11A Pediatric Extrapolation
On 26 August 2022 the FDA published draft guidance on ICH E11A.
Read more online Read
  • 05 September 2022
  • 173
Guidance for Applicants/MAHs Involved in GMP, GCP and GVP Inspections Coordinated by EMA
On 31 August 2022 the EMA published guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA, version 3.0.
Read the pdf Read
  • 26 August 2022
  • 283
Changes to Guidance Document Authorization Procedures for COVID-19 Medicinal Products During a Pandemic HMV4
1 August 2022 — Swissmedic published the revised guidance document effective 1 August 2022.
Read more online Read
  • 26 August 2022
  • 209
Digital Application Dataset Integration (DADI) Q&A Webinar - Variations Form for Human Medicinal Products
2 August 2022 — EMA published the DADI Q&A webinar summary document.
Read the pdf Read
  • 26 August 2022
  • 235
News Bulletin for Small and Medium-Sized Enterprises (SME)
2 August 2022 — EMA published Issue 56 of the SME Office Newsletter.
Read the pdf Read
  • 26 August 2022
  • 196
Application for Priority Applicant Determination - Medical Devices
2 August 2022 — Australian Therapeutic Goods Administration (TGA) announced the availability of the application form for priority applicant determination of medical devices.
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
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /