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
  • 16 April 2020
  • 1264
Overview of Comments Received on ICH Guideline E8 (R1) on General Considerations for Clinical Studies
On 7 April 2020 the EMA published an overview of comments received from 40 stakeholders on ICH guideline E8(R1).
Read the pdf Read
  • 16 April 2020
  • 1295
Bioresearch Monitoring (BIMO) Fiscal Year 2019 Metrics
On 8 April 2020 the FDA published the bioresearch monitoring inspection metrics for the fiscal year 2019.
Read more online Read
  • 16 April 2020
  • 3628
Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak
On 9 April 2020 the UK MHRA published the guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home.
Read more online Read
  • 16 April 2020
  • 1142
Guidance on regulatory requirements in the context of the COVID-19 pandemic
On 10 April the European Commission, EMA and the European medicines regulatory network have developed a Q&A document to provide guidance to stakeholders on
Read the pdf Read
  • 16 April 2020
  • 1138
Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
On 13 April 2020 the FDA announced the availability of this final guidance for industry.
Read more online Read
  • 16 April 2020
  • 1140
Pharmacovigilance Inspection Metrics Report (April 2018 – March 2019)
On 15 April 2020 the UK MHRA published the annual report of pharmacovigilance inspection metrics from April 2018 till March 2019.
Read the pdf Read
  • 30 March 2020
  • 1234
Medical Devices Clinical Investigations during the Coronavirus (COVID-19) outbreak
On 30 March 2020 the MHRA published the updated this guidance for investigators and sponsors of ongoing clinical investigations and new applications.
Read more online Read
  • 26 March 2020
  • 1536
EMA EudraVigilance Registration Manual
On 26 March 2020 the EMA updated the EudraVigilance XCOMP (Test system) registration process.
Read the pdf Read
  • 24 March 2020
  • 1274
Global Regulators Map out Data Requirements for Phase 1 COVID-19 Vaccine Trials
On 24 March 2020 the EMA announced that global regulators have published a report presenting the outcomes of a workshop on COVID-19 vaccine development.
Read the pdf Read
  • 20 March 2020
  • 1709
EMA Management Board – highlights of March 2020 meeting
On 20 March 2020 the EMA highlighted the update on the development of the Clinical Trials Information System (CTIS) for the EU Clinical Trials Regulation.
Read more online Read
  • 20 March 2020
  • 1229
EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
On 20 March 2020 the EMA issued this guidance for industry, investigators and IRBs and on 27 March updated it.
Read the pdfRead more online Read
  • 20 March 2020
  • 1196
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
On 20 March 2020 the FDA announced the availability of this final guidance for industry.
Read more online Read
  • 18 March 2020
  • 1125
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
On 18 March 2020 the FDA issued this final guidance for industry, investigators and IRBs and on 27 March updated it.
Read more online Read
  • 18 March 2020
  • 1221
Guidance on Paediatric Submissions
On 18 March 2020 the EMA issued the new guidance on eSubmission Gateway and eSubmission web client for paediatric investigation.
Read the pdf Read
  • 13 March 2020
  • 1194
Competitive Generic Therapies
On 13 March 2020 the FDA announced the availability of the final guidance for industry.
Read more online Read
  • 12 March 2020
  • 1397
510(k) Third Party Review Program
On 12 March 2020 the FDA issued the guidance for industry, FDA staff and third party review organizations.
Read more online Read
  • 10 March 2020
  • 1089
Providing Regulatory Submissions in Alternate Electronic Format
On 10 March 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 11 May 2020.
Read more online Read
  • 10 March 2020
  • 1073
GCP Inspections: Expectations and the dos and don’ts for hosting
On 10 March 2020 the MHRA posted the expectations of GCP inspections in the blog of the MHRA inspectorate.
Read more online Read
  • 10 March 2020
  • 1084
Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections
On 10 March 2020 the FDA announced that the agency halts routine inspections overseas through April due to coronavirus.
Read more online Read
  • 10 March 2020
  • 4800
China awards Gilead’s remdesivir patents, scolds local pharma over newsjacking
On 10 March 2020 GBI discussed China’s IP landscape and issues surrounding patent standards.
Read more online Read
  • 05 March 2020
  • 1183
Safety Testing of Drug Metabolites
On 5 March 2020 the FDA announced the availability of the final guidance for industry.
Read more online Read
  • 04 March 2020
  • 1128
ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management
On 4 March 2020 the EMA published the Step 5 for ICH guideline Q12.
Read the pdf Read
  • 04 March 2020
  • 1397
EFPIA CDEG position paper on the use of Form FDA 1572 for clinical trials performed outside the USA
The EFPIA Clinical Development Expert Group (CDEG) published the position paper providing recommendations on the use of Form FDA 1572 for non-IND sites.
Read the pdf Read
  • 02 March 2020
  • 1702
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
On 18 February 2020 the EMA published the Step 5 on ICH E9 (R1) addendum on estimands and sensitivity in clinical trials.
Read the pdf Read
  • 02 March 2020
  • 1260
Orphan medicines in the EU
On 28 February 2020 the EMA published the leaflet on orphan medicines in the EU.
Read the pdf Read
  • 02 March 2020
  • 1398
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
On 21 February 2020 the FDA announced the availability of the final guidance for industry.
Read more online Read
  • 02 March 2020
  • 1399
Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics
On 19 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 20 April 2020.
Read more online Read
  • 02 March 2020
  • 1786
Good manufacturing practice
On 19 February 2020 the EMA updated the GMP guidelines.
Read more online Read
  • 02 March 2020
  • 1289
European Medicines Agency’s Privacy Statement
On 19 February 2020 the EMA published its privacy statement for the pre-employment medical examination.
Read the pdf Read
  • 02 March 2020
  • 1284
ICH S5 (R3) guideline on reproductive toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals
On 18 February 2020 the EMA published the Step 5 on ICH S5 (R3) guideline on reproductive toxicology.
Read the pdf Read
  • 01 March 2020
  • 1348
New Address for Widler & Schiemann AG in Zug
From 1 March 2020, the company Widler & Schiemamm AG has a new address: Baarerstrasse 75, 6300 Zug
Read more online Read
  • 18 February 2020
  • 1308
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry
On 3 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 2 April 2020.
Read more online Read
  • 18 February 2020
  • 1202
European Medicines Agency’s privacy statement for public and targeted consultation
On 14 February 2020 the EMA published its privacy statement for public and targeted consultation.
Read the pdf Read
  • 18 February 2020
  • 1527
Products Management Services (PMS) -Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
On 11 February 2020 the EMA announced the availability of the guideline of implementation of the ISO IDMP standards.
Read the pdf Read
  • 18 February 2020
  • 1285
Substances, Products, Organisations, Referentials (SPOR)
On 11 February 2020 the EMA announced the availability of the SPOR Application Programming Interface (API) version 2 specification.
Read the pdf Read
  • 18 February 2020
  • 3138
ICH M9 guideline on biopharmaceutics classification system-based biowaivers
On 11 February 2020 the EMA announced that ICH M9 reached step 5 of the ICH process.
Read more online Read
  • 18 February 2020
  • 1286
ICH M9 guideline on biopharmaceutics classification system-based biowaivers
On 11 February 2020 the EMA announced that ICH M9 reached step 5 of the ICH process.
Read more online Read
  • 18 February 2020
  • 1227
European Medicines Agency privacy statement for the organisation of meetings and events
On 7 February 2020 the EMA published its privacy statement for the organisation of meetings and events.
Read the pdf Read
  • 18 February 2020
  • 1378
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
On 6 February 2020 the EMA updated its pre-authorisation procedural advice for users of the centralised procedure.
Read the pdf Read
  • 18 February 2020
  • 1221
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry
On 5 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 6 April 2020.
Read more online Read
  • 18 February 2020
  • 2094
Quality of medicines questions and answers: Part 1
On 05 February 2020 the EMA updated the questions and answers on matters related to the quality of medicines.
Read more online Read
  • 18 February 2020
  • 1566
EMA to support development of vaccines and treatments for novel coronavirus disease
On 04 February 2020 the EMA announced to support development of vaccines and treatments for novel coronavirus disease.
Read more online Read
  • 18 February 2020
  • 1272
Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry
On 4 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 3 April 2020.
Read more online Read
  • 18 February 2020
  • 1267
European Medicines Agency - Privacy statement for Selection and Recruitment
On 03 February 2020 the EMA updated its privacy statement for selection and recruitment.
Read the pdf Read
  • 07 February 2020
  • 1741
China Regulatory Policy Landscape snapshot and future perspective for Drugs and Biologics
Join us on 11 February 2020 at 10:00 AM Eastern Time (US and Canada) for the Regulatory Intelligence Working Group Monthly Meeting
Read more online Read
  • 31 January 2020
  • 3025
Ten recommendations to unlock the potential of big data for public health in the EU
On 20 January 2020 the joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) proposed ten priority actions for the European medicines regulatory network.
Read more online Read
  • 31 January 2020
  • 1478
Electronic product information for human medicines in the EU: key principles
On 29 January 2020 the EMA published the key principles outlining a harmonised approach to develop and use electronic product information (ePI) for human medicines across the EU.
Read the pdf Read
  • 31 January 2020
  • 1295
EMA supporting small and medium-sized enterprises (SMEs)
On 28 January 2020 EMA updated supporting SMEs.
Read more online Read
  • 31 January 2020
  • 1374
FDA Continues Strong Support of Innovation in Development of Gene Therapy Products
On 28 January 2020 FDA announced that it continues its efforts to support innovators developing gene therapy products.
Read more online Read
  • 31 January 2020
  • 1267
Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment
On 24 January 2020 FDA announced the availability of the final guide for industry.
Read more online Read
  • 31 January 2020
  • 2219
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017
On 23 January 2020 FDA announced the availability of the final guide for industry.
Read more online Read
  • 31 January 2020
  • 1391
Procedural advice for orphan medicinal product designation
On 21 January 2020 EMA updated this guidance for sponsors.
Read the pdf Read
  • 16 January 2020
  • 1407
Q&A on impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations
On 7 January 2020 EMA updated how the EU-USA Mutual Recognition Agreement (MRA) affects marketing authorisation applications or variations.
Read the pdf Read
  • 16 January 2020
  • 1604
Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers
On 15 January 2020 FDA announced the availability of the guide for industry. Comments may submit by 16 March 2020.
Read more online Read
  • 16 January 2020
  • 1253
Mandatory use of international standard for the reporting of side effects to improve safety of medicines
On 15 January 2020 the EMA management board announced the confirmation of the mandatory use of the ISO Individual Case Report standard based on ICH E2B(R3) modalities and related ISO standard terminology.
Read more online Read
  • 16 January 2020
  • 1388
IRIS guide for Parallel Distribution applicants
On 10 January 2020 EMA updated the IRIS guide for parallel distribution applicants.
Read the pdf Read
  • 16 January 2020
  • 1253
Human medicines: highlights of 2019
On 9 January 2020 EMA published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use.
Read more online Read
  • 02 January 2020
  • 1321
4-Year Overview of Pharmacovigilance Activities in the EU Shows Robust and Effective Medicines Safety System
On 17 December 2019 the EMA released the report on the impact of pharmacovigilance measures covering the period 01 January 2015 to 31 December 2018.
Read the pdf Read
  • 02 January 2020
  • 1275
Brexit update: the United Kingdom's withdrawal from the European Union
On 20 December 2019 the EMA updated the UK withdrawal from the EU.
Read more online Read
  • 02 January 2020
  • 1385
MHRA phase I accreditation scheme
On 20 December 2019 the MHRA updated the List of Accredited Phase I Units.
Read the pdf Read
  • 02 January 2020
  • 1495
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
On 20 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 21 February 2020.
Read more online Read
  • 02 January 2020
  • 1563
EMA Building
Orientation Guide for Industry
Read the pdf Read
  • 02 January 2020
  • 1325
Bridging for Drug-Device and Biologic-Device Combination Products
On 18 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 18 February 2020.
Read more online Read
  • 02 January 2020
  • 1344
Launch of international pilot programme on inspection of manufacturers of sterile medicines
On 17 December 2019 the EMA updated the international collaboration on GMP inspections.
Read the pdf Read
  • 16 December 2019
  • 1436
Qualification Process for Drug Development Tools
On 12 December 2019 the FDA announced the availability of the draft guidance for industry and FDA staff. Comments may be submitted by 7 February 2020.
Read more online Read
  • 16 December 2019
  • 1867
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with chapter P.III on pharmacovigilance for the use of medicines by pregnant and breastfeeding women
On 11 December 2019 the EMA updated the guidelines on GVP.
Read the pdf Read
  • 16 December 2019
  • 1333
How will pharmacovigilance look in 2030?
On 10 December 2019 the EMA published the news about the predictions for the key elements of Pharmacovigilance in 2030.
Read more online Read
  • 16 December 2019
  • 1357
Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids
On 6 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 7 February 2020.
Read more online Read
  • 16 December 2019
  • 3203
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment
On 4 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 2 February 2020.
Read more online Read
  • 16 December 2019
  • 1387
Guide on access to unpublished documents
On 9 December 2019 the EMA updated the guide on access to unpublished documents.
Read the pdf Read
  • 16 December 2019
  • 1340
China tightens drug administration as law takes effect
China's revised drug administration law, adopted by the top legislature in August, went into effect on Dec 1, as part of the country's efforts to strengthen supervision to ensure drug safety.
Read more online Read
  • 16 December 2019
  • 1255
ICH Q12 and Annexes reach Step 4 of the ICH Process
The ICH Q12 and its Annexes reached Step 4 of the ICH Process at the ICH meeting in Singapore on 21 November 2019.
Read more online Read
  • 16 December 2019
  • 1658
European Medicines Agency’s Privacy Statement concerning requests for information or access to documents
On 26 November 2019 the EMA published its privacy statement explaining requests for information or access to documents
Read the pdf Read
  • 02 December 2019
  • 1286
Would FDA support these approaches: Flipped Clinical Trials and One Indication, One Standardized Protocol, Multiple IMPs?
On 7 November 2019 the FDA held a public meeting on Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA's Office of New Drugs
Read more online Read
  • 02 December 2019
  • 1558
Report from the Commission to the European Parliament and the Council on the National and European Medicines Agency Experience Regarding the List of Medicines for Human Use Subject to Additional Monitoring
On 15 November 2019 the European Commission published the report concerning the experience gained regarding Additional Monitoring
Read more online Read
  • 02 December 2019
  • 1443
Procedural advice for orphan medicinal product designation
On 19 November 2019 the EMA updated this guidance for sponsors.
Read the pdf Read
  • 02 December 2019
  • 1593
Transdermal and Topical Delivery Systems - Product Development and Quality Considerations
On 20 November 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 19 February 2020.
Read more online Read
  • 02 December 2019
  • 1411
Certificates of Confidentiality
On 22 November 2019 the FDA announced the availability of the draft guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and FDA Staff. Comments may be submitted by 08 January 2020.
Read more online Read
  • 02 December 2019
  • 1463
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products
On 25 November 2019 the FDA announced the availability of the draft guidance for comments by 27 January 2020.
Read more online Read
  • 02 December 2019
  • 1599
Adaptive Designs for Clinical Trials of Drugs and Biologics
On 29 November 2019 the FDA announced the final guidance for industry. Adaptive designs for clinical trials allow for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. They are intended to support the effectiveness and safety of drugs.
Read the pdfRead more online Read
  • 02 December 2019
  • 3541
How to handle remote monitoring?
EFGCP audit working party discussed the questions regarding to the remote monitoring.
Read
  • 18 November 2019
  • 1452
Status of ICH Guidelines implementation by ICH Regulatory Members
On 1 November 2019 a report of monitoring the adequacy of implementation and adherence to ICH guidelines available on the ICH website
Read the pdf Read
  • 18 November 2019
  • 1670
EudraVigilance Release Notes v.1.22
On 4 November 2019 the EMA updated the EudraVigilance Release Notes v1.22
Read the pdf Read
  • 18 November 2019
  • 1495
Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff
On 7 November 2019 the FDA is establishing a public docket to collect comments on the draft document. Comments may be submitted by 6 January 2010
Read more online Read
  • 18 November 2019
  • 3540
EMA EudraVigilance Registration Manual
On 13 November 2019 the EMA published the updated EudraVigilance registration manual
Read the pdf Read
  • 18 November 2019
  • 1887
New Organization First User QPPV/RP or Change of EU QPPV/RP
On 13 November 2019 the EMA published the updated First User or Change of EU QPPV/RP for new organization
Read the pdf Read
  • 18 November 2019
  • 3287
EMA Regulatory Science to 2025 - Five goals
On 14 November 2019 the EMA updated its five goals for human medicine regulation
Read the pdf Read
  • 18 November 2019
  • 1372
Guideline on clinical investigation of medicinal products for the treatment of gout
On 14 November 2019 EMA updated the guidance to provide the evaluation of drugs for the treatment of gout. This guide will come into effect on 1 June 2020.
Read the pdf Read
  • 18 November 2019
  • 1506
Smallpox (Variola Virus) Infection: Developing
Drugs for Treatment or Prevention Guidance for Industry
Read more online Read
  • 04 November 2019
  • 3139
EMA updated Inspections procedure
On 7 October 2019, the 1,000th good clinical practice (GCP) inspection requested by EMA’s human medicines committee (CHMP) and coordinated by EMA was carried out.
Read more online Read
  • 04 November 2019
  • 1515
Providing Regulatory Submissions in Electronic Format: IND Safety Reports
On October 29, 2019 FDA published this draft guidance for comment by December 30, 2019. This guidance only applies to IND safety reports for serious and unexpected suspected adverse reactions required under 21 CFR 312.32(c)(1)(i).
Read more online Read
  • 04 November 2019
  • 1481
Electronic Submission of IND Safety Reports Technical Conformance Guide
This Document supplements the following Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND Safety Reports (October 2019).
Read more online Read
  • 04 November 2019
  • 1553
Biosimilars in the EU - Information guide for healthcare professionals
On October 29, 2019 EMA and EC updated the guide on biosimilars in the EU. This guide was first published in May 2017.
Read the pdf Read
  • 04 November 2019
  • 3110
Dialogue with Chinese authorities on medicine regulation
On October 25, 2019 the Chinese National Medical Product Administration (NMPA) delegation visited EMA. The visit took place in the context of the ongoing EU-China regulatory dialogue on pharmaceuticals.
Read more online Read
  • 04 November 2019
  • 1812
Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act
On October 24, 2019 FDA posted this draft guidance for industry. Comments may be submitted by December 24, 2019
Read more online Read
  • 04 November 2019
  • 1528
Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)
On 21 October 2019, EMA updated the questions and answers. This update focuses on aspects relating to the implementation and applicability of the requirements of Regulation (EU) 2017/745 to medicinal products with an integral or co-packaged medical device.
Read the pdf Read
  • 04 November 2019
  • 1455
Drug Master Files (DMFs) Guidance for Industry
On 18 October 2019 FDA announced the availability of this draft guidance. Once finalized, this guidance will provide FDA's current thinking on DMFs. Comments may be submitted by December 12, 2019.
Read more online Read
  • 04 November 2019
  • 1374
Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs)
On 10 October 2019 European Commission issued the guidelines on GCP specific to clinical trials conducted with ATMPs
Read the pdf Read
  • 17 October 2019
  • 1449
Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit
MHRA updated this guidance on October 11, 2019. Pharmacovigilance system requirements if there is a no-deal Brexit.
Read more online Read
  • 17 October 2019
  • 1337
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry
On October 9, 2019 FDA announced the availability of the final guidance for industry. This guidance describes an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic in an oncology clinical trial is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements.
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. /