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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.

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  • 21 September 2022
  • 28
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.
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  • 21 September 2022
  • 23
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.
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  • 21 September 2022
  • 27
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.
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  • 21 September 2022
  • 22
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.
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  • 21 September 2022
  • 32
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On 7 September 2022 the FDA published draft guidance on clinical pharmacology considerations for pediatric studies.
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  • 21 September 2022
  • 21
EMA IRIS Industry Training for GVP Inspections
On 8 September the EMA published their online training sessions of IRIS for GCP inspections.
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  • 21 September 2022
  • 29
Medical Devices: Software Applications (Apps)
On 8 September 2022 the MHRA published updated guidance on software apps as medical devices.
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  • 21 September 2022
  • 32
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.
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  • 21 September 2022
  • 28
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.
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  • 21 September 2022
  • 17
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.
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  • 21 September 2022
  • 19
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.
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  • 21 September 2022
  • 22
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.
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  • 21 September 2022
  • 23
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.
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  • 21 September 2022
  • 30
Q3D(R2) – Guideline for Elemental Impurities
On 14 September 2022 the FDA published draft guidance on elemental impurities.
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  • 05 September 2022
  • 45
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
On 17 August 2022 FDA issued final guidance for industry and FDA staff.
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  • 05 September 2022
  • 67
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.
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  • 05 September 2022
  • 66
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.
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  • 05 September 2022
  • 68
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.
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  • 05 September 2022
  • 55
Innovation, Quality & Transparency – a Compliance Team 1 Perspective
On 23 August 2022 UK MHRA Inspectorate published a blog on Compliance Matters.
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  • 05 September 2022
  • 62
EMA EudraVigilance Registration Manual
On 23 August 2022 EMA published the updated EudraVigilance registration manual.
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  • 05 September 2022
  • 55
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.
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  • 05 September 2022
  • 58
FAQs: Transitional Trials from EudraCT to CTIS
On 24 August 2022 EMA published the CTIS training program, module 23, version 1.2.
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  • 05 September 2022
  • 61
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.
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  • 05 September 2022
  • 52
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.
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  • 05 September 2022
  • 81
Q2(R2) Validation of Analytical Procedures
On 26 August 2022 the FDA published draft guidance on ICH Q2(R2).
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  • 05 September 2022
  • 65
Q14 Analytical Procedure Development
On 26 August 2022 the FDA published draft guidance on ICH Q14.
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  • 05 September 2022
  • 65
M12 Drug Interaction Studies
On 26 August 2022 the FDA published draft guidance on ICH M12.
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  • 05 September 2022
  • 60
E11A Pediatric Extrapolation
On 26 August 2022 the FDA published draft guidance on ICH E11A.
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  • 05 September 2022
  • 51
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.
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  • 26 August 2022
  • 100
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.
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  • 26 August 2022
  • 82
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.
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  • 26 August 2022
  • 105
News Bulletin for Small and Medium-Sized Enterprises (SME)
2 August 2022 — EMA published Issue 56 of the SME Office Newsletter.
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  • 26 August 2022
  • 81
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.
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  • 26 August 2022
  • 79
Version 2.8 of Technical Documentation - UDI/Devices Registration
2 August 2022 — European Commission published the technical documentation version 2.8 for unique device identifier (UDI)/Devices registration.
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  • 26 August 2022
  • 71
Clinical Trials for Medicines: Manage Your Authorization, Report Safety Issues
2 August 2022 — MHRA updated the guidance on clinical trials for medicines.
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  • 26 August 2022
  • 87
Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies
2 August 2022 — FDA published draft guidance for industry. Submit comments by 3 October 2022.
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  • 26 August 2022
  • 96
EMA Initiatives for Acceleration of Development Support and Evaluation Procedures for COVID-19 Treatments and Vaccines
3 August 2022 — EMA published guidance on rapid formal review procedures related to COVID-19.
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  • 26 August 2022
  • 82
Decommission of eSUSAR
3 August 2022 — MHRA inspectorate announced decommission of eSUSAR.
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  • 26 August 2022
  • 98
Complex Generics News
5 August 2022 — FDA published up-to-date information on FDA’s actions on complex generics.
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  • 26 August 2022
  • 100
Bioresearch Monitoring Technical Conformance Guide
5 August 2022 — FDA published technical specifications guidance on bioresearch monitoring technical conformance guide.
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  • 26 August 2022
  • 97
IRIS for Good Pharmacovigilance Practice (GVP) Inspections Training Session for Industry Users
9 August 2022 — EMA announced the GVP inspections training session on 7 September 2022.
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  • 26 August 2022
  • 94
EVVet3 Production - Release Notes
8 August 2022 — EMA published v1.6 release notes of EVVet3.
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  • 26 August 2022
  • 85
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
15 August 2022 — FDA published the technical specifications document of the final E2B(R3) guidance for industry.
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  • 26 August 2022
  • 91
Complex Generics News
5 August 2022 — FDA published up-to-date information on FDA’s actions on complex generics.
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  • 26 August 2022
  • 86
Bioresearch Monitoring Technical Conformance Guide
5 August 2022 — FDA published technical specifications guidance on bioresearch monitoring technical conformance guide.
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  • 26 August 2022
  • 79
IRIS for Good Pharmacovigilance Practice (GVP) Inspections Training Session for Industry Users
9 August 2022 — EMA announced the GVP inspections training session on 7 September 2022.
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  • 26 August 2022
  • 93
EVVet3 Production – Release Notes
8 August 2022 — EMA published v1.6 release notes of EVVet3.
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  • 26 August 2022
  • 89
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
15 August 2022 — FDA published the technical specifications document of the final E2B(R3) guidance for industry.
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  • 21 August 2022
  • 94
Clinical Trials for Medicines: Apply for Authorization in the UK
On 18 July 2022 the MHRA updated the guidance on clinical trials for medicines.
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  • 21 August 2022
  • 100
Evaluation of Therapeutic Equivalence
On 21July 2022 the FDA published the draft guidance on evaluation of therapeutic equivalence of generic drugs. Submit comments by 19 September 2022.
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  • 21 August 2022
  • 101
Good Laboratory Practice (GLP) for Safety Tests on Chemicals
On 21 July 2022 the MHRA updated the guidance on GLP
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  • 21 August 2022
  • 111
ICH Guideline M12 on Drug Interaction Studies
On 21 July 2022 the EMA published the draft ICH guideline M12, step 2b.
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  • 21 August 2022
  • 105
Global Regulators Call for International Collaboration to Integrate Real-World Evidence into Regulatory Decision-Making
On 22 July 2022 the EMA announced the availably of a joint ICMRA statement on international collaboration to enable RWE for regulatory decision-making.
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  • 21 August 2022
  • 105
Real-Time Oncology Review (RTOR)
On 22 July 2022 the FDA published the draft guidance on real-time oncology review for industry. Submit comments by 20 September 2022.
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  • 21 August 2022
  • 131
Conducting Remote Regulatory Assessments Questions and Answers
On 22 July 2022 the FDA published the draft Q&A guidance on conducting remote regulatory assessments for industry.
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  • 21 August 2022
  • 135
Failure to Respond to an Abbreviated New Drug Applications (ANDA) Complete Response Letter (CRLs) within the Regulatory Timeframe
On 22 July 2022 the FDA published the final guidance on responding to complete response letters (CRLs) from FDA for industry.
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  • 21 August 2022
  • 133
Orange Book Questions and Answers Guidance for Industry
On 22 July 2022 the FDA published the final orange book Q&A guidance for industry.
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  • 21 August 2022
  • 90
Unique Device Identification (UDI): Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices
On 22 July 2022 the FDA published the final UDI guidance for industry and FDA staff.
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  • 21 August 2022
  • 96
Clinical Trials Highlights - July 2022
On 25 July 2022 the EMA published the Clinical Trials Highlights, issue 10.
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  • 21 August 2022
  • 98
ICH Guideline M10 on Bioanalytical Method Validation and Study Sample Analysis
On 27 July 2022 the EMA published the ICH guideline M10, step 5.
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  • 21 August 2022
  • 100
ICH Guideline M10 on Bioanalytical Method Validation and Study Sample Analysis – Frequently Asked Questions (FAQ)
On 27 July 2022 the EMA published the FAQ on ICH guideline M10, step 5.
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  • 21 August 2022
  • 102
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
On 27 July 2022 the FDA published the final guidance on general clinical pharmacology considerations for neonatal studies
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  • 21 August 2022
  • 85
Laser-Assisted in Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations
On 28 July 2022 the FDA published the draft guidance on patient labeling recommendations for LASIK lasers for industry and FDA staff. Submit comments by 26 October 2022.
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  • 21 August 2022
  • 117
Qualification Opinion of the Use of Enroll-HD (A Huntington’s Disease Patient Registry) as a Data Source and Infrastructure Support for Post-Authorization Monitoring of Medical Products
On 28 July 2022 the EMA published the qualification opinion on the use of Enroll-HD as a data source and infrastructure support for post-authorization monitoring of medical products.
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  • 21 August 2022
  • 86
Register Medical Devices to Place on the Market
On 28 July 2022 the MHRA updated the guidance on registration of medical devices.
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  • 21 August 2022
  • 133
PMDA Guidance on Risk Management Plan (RMP)
On 29 July 2022 the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) posted RMP page renewal, Q&A, templates, instructions and publication.
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  • 19 July 2022
  • 136
Questions & Answers - Practical Arrangements on the Companion Diagnostics Consultation Procedure to the European Medicines Agency by Notified Bodies
1 July 2022 — EMA published updated Q&A guidance on diagnostic consultation procedures.
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  • 19 July 2022
  • 703
Guidance on Applying the 2021 Advertising Code Rules
1 July 2022 — Australian Therapeutic Goods Administration (TGA) published the guidance on applying the advertising code rules for therapeutic goods.
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  • 19 July 2022
  • 154
Guideline on Advertising, etc. of Medicinal Products for Human Use
5 July 2022 — Danish Medicines Agency updated guideline on advertising of medicinal products for human use.
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  • 19 July 2022
  • 152
Identifying Trading Partners Under the Drug Supply Chain Security Act
5 July 2022 — FDA issued the draft guidance for industry. Submit comments by 05 September 2022.
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  • 19 July 2022
  • 144
OPEN Pilot: One-year Review and Recommendations
7 July 2022 — EMA published the OPEN Pilot report.
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  • 19 July 2022
  • 176
Consultation on Regulatory Guidelines for Laboratory Developed Tests (LDTs)
12 July 2022 — Singapore Health Sciences Authority (HAS) announced the release of a draft regulatory guidelines for LDTs for stakeholders' consultation.
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  • 19 July 2022
  • 521
Information about the Raw Data Proof-of-Concept Pilot for Industry
12 July 2022 — EMA announced the availability of access to raw data for marketing authorization and post-authorization applications submitted to the EMA.
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  • 19 July 2022
  • 164
GCP Inspection Site Report Template on Behalf of the EMA
12 July 2022 — EMA published the updated GCP inspection procedures for appendix 1 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP.
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  • 19 July 2022
  • 162
Joint Controllership Arrangement: EudraVigilance Human (EV) Personal Data Capture
13 July 2022 — EMA published legal framework for the purpose of processing personal data captured in EudraVigilance Human (EV) administered by EMA
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  • 19 July 2022
  • 142
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological
14 July 2022 — FDA published the final guidance for industry.
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  • 19 July 2022
  • 237
Horizon Scanning Case Study: Point of Care Manufacture
15 July 2022 — UK MHRA published the horizon scanning case study.
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  • 19 July 2022
  • 153
The ICH Drug Interaction Studies M12 Draft Guideline Now Available Online
ICH announced the availability of the M12 draft guideline presentation.
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  • 19 July 2022
  • 188
Technology Capability Investment Plan
15 July 2022 — EMA published technology capability investment plan for becoming the digital hub for the European Medicines Regulatory Network.
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  • 19 July 2022
  • 180
European Medicines Agency’s Data Protection Notice for EudraVigilance Human (EV)
15 July 2022 — EMA published updated data protection notice for EudraVigilance Human.
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  • 11 July 2022
  • 188
Questions and Answers - Complex Clinical Trials
2 June 2022 — European Commission published updated Q&A guidance on complex clinical trials, version 2022-05-23.
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  • 11 July 2022
  • 192
Compliance Monitor (CM) Overview and Application Process
15 June 2022 — MHRA published updated guidance on the eligibility of the compliance monitor.
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  • 11 July 2022
  • 160
Marketing Authorization Application (MAA) Submission Dates for 150-days National and European Commission Decision Reliance Procedures
20 June 2022 — MHRA published updated guidance on MAA submission dates.
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  • 11 July 2022
  • 179
Guidance on Handling of Decentralized and Mutual Recognition Procedures Which are Approved or Pending
24 June 2022 — MHRA published updated guidance on the approach the MHRA intends to take for products approved or pending in decentralized procedure (DCP) or mutual recognition procedures (MRP).
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  • 11 July 2022
  • 243
European Medicines Agency Post-Authorization Procedural Advice for Users of the Centralized Procedure
20 June 2022 — EMA published updated Q&A guidance on extensions of marketing authorizations.
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  • 11 July 2022
  • 166
European Medicines Agency Pre-Authorization Procedural Advice for Users of the Centralized Procedure
20 June 2022 — EMA published updated pre-authorization Q&A guidance.
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  • 11 July 2022
  • 178
Updated IRIS Guide for Industry and Individual Applicants
28 June 2022 — EMA published the updated IRIS guide on how to create and submit scientific applications.
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  • 11 July 2022
  • 266
Workshop Report on Data Quality Framework for Medicines Regulation
29 June 2022 — EMA published workshop report on data quality framework for medicines regulation.
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  • 11 July 2022
  • 173
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) User Manual
7 June 2022 — EMA published version 5.7 of the EVWEB user manual.
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  • 11 July 2022
  • 182
Article 57 User Interface (UI) Installation Guide
7 June 2022 — EMA published updated installation guide on article 57 UI components and initial set-up.
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  • 11 July 2022
  • 181
Orphans: Regulatory and Procedural Guidance and Forms
9 June 2022 — EMA announced updated procedural guidance documents on orphan designation.
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  • 11 July 2022
  • 176
Changing the Name or Address of a Sponsor
9 June 2022 — EMA announced update for submitting a request to change the name or address.
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  • 11 July 2022
  • 155
Mandatory Use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Using the EudraVigilance System
15 June 2022 — EMA announced EudraVigilance System online training course.
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  • 11 July 2022
  • 157
Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
16 June 2022 — FDA published the final guidance for industry and FDA staff.
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  • 11 July 2022
  • 158
Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures
21 June 2022 — FDA issued draft guidance for industry and FDA staff. Submit comments by 22 August 2022.
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  • 11 July 2022
  • 166
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
24 June 2022 — FDA published final guidance.
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  • 11 July 2022
  • 181
Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
27 June 2022 — FDA issued draft guidance for comments by 25 September 2022.
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  • 11 July 2022
  • 233
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment
27 June 2022 — FDA published final industry guidance on the treatment of renal cell carcinoma.
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  • 11 July 2022
  • 165
Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment
27 June 2022 — FDA published final industry guidance on the treatment of bladder cancer.
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  • 11 July 2022
  • 236
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
29 June 2022 — FDA issued draft guidance for comments by 28 September 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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