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  • 16 January 2020
  • 264
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.
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  • 02 January 2020
  • 334
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.
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  • 02 January 2020
  • 327
Brexit update: the United Kingdom's withdrawal from the European Union
On 20 December 2019 the EMA updated the UK withdrawal from the EU.
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  • 02 January 2020
  • 335
MHRA phase I accreditation scheme
On 20 December 2019 the MHRA updated the List of Accredited Phase I Units.
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  • 02 January 2020
  • 343
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On 20 December 2019 the FDA announced the availability of the draft guidance for industry.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.
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  • 02 January 2020
  • 373
EMA Building
Orientation Guide for Industry
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  • 02 January 2020
  • 342
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On 18 December 2019 the FDA announced the availability of the draft guidance for industry.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.
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  • 02 January 2020
  • 330
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.
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  • 16 December 2019
  • 378
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On 12 December 2019 the FDA announced the availability of the draft guidance for industry and FDA staff.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.
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  • 16 December 2019
  • 734
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.
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  • 16 December 2019
  • 360
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.
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  • 16 December 2019
  • 354
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.
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  • 16 December 2019
  • 384
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.
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  • 16 December 2019
  • 369
Guide on access to unpublished documents
On 9 December 2019 the EMA updated the guide on access to unpublished documents.
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  • 16 December 2019
  • 360
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.
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  • 16 December 2019
  • 315
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.
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  • 16 December 2019
  • 610
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
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  • 02 December 2019
  • 372
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
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  • 02 December 2019
  • 421
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
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  • 02 December 2019
  • 423
Procedural advice for orphan medicinal product designation
On 19 November 2019 the EMA updated this guidance for sponsors.
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  • 02 December 2019
  • 404
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.
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  • 02 December 2019
  • 398
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.
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  • 02 December 2019
  • 467
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.
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  • 02 December 2019
  • 435
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.
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  • 02 December 2019
  • 414
How to handle remote monitoring?
EFGCP audit working party discussed the questions regarding to the remote monitoring.
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  • 18 November 2019
  • 461
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
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  • 18 November 2019
  • 410
EudraVigilance Release Notes v.1.22
On 4 November 2019 the EMA updated the EudraVigilance Release Notes v1.22
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  • 18 November 2019
  • 455
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
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  • 18 November 2019
  • 475
EMA EudraVigilance Registration Manual
On 13 November 2019 the EMA published the updated EudraVigilance registration manual
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  • 18 November 2019
  • 479
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
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  • 18 November 2019
  • 403
EMA Regulatory Science to 2025 - Five goals
On 14 November 2019 the EMA updated its five goals for human medicine regulation
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  • 18 November 2019
  • 375
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.
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  • 18 November 2019
  • 424
Smallpox (Variola Virus) Infection: Developing
Drugs for Treatment or Prevention Guidance for Industry
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  • 04 November 2019
  • 390
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.
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  • 04 November 2019
  • 418
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).
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  • 04 November 2019
  • 420
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).
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  • 04 November 2019
  • 482
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.
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  • 04 November 2019
  • 436
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.
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  • 04 November 2019
  • 383
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
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  • 04 November 2019
  • 465
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.
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  • 04 November 2019
  • 366
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.
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  • 04 November 2019
  • 335
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
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  • 17 October 2019
  • 454
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.
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  • 17 October 2019
  • 434
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.
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  • 17 October 2019
  • 535
PRIME (priority medicines) Eligibility Requests
On October 4, 2019 EMA announced deadlines for submission and timetable for assessment in 2020
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  • 17 October 2019
  • 735
Investigational Enzyme Replacement Therapy (ERT) Products: Nonclinical Assessment
On October 1, 2019 FDA published this guidance for comment purposes only. Submit comments by January 2, 2020.
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  • 17 October 2019
  • 476
FDA’s Top GMP Inspection Findings for Fiscal Year 2019
Drugmakers continue to stumble at the same old hurdles: failure to document quality unit responsibilities and procedures
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  • 30 September 2019
  • 538
Clinical Decision Support Software
FDA issued a draft guidance document on Clinical Decision Support Software on September 27, 2019 and opened for public comment until December 26, 2019.
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  • 30 September 2019
  • 643
NMPA officially joins Medical Device Regulators Forum (IMDRF) National Competent Authorities Report (NCAR) Exchange Program
On September 19, 2019 the IMDRF approved the Chinese National Medical Products Administration (NMPA) to join the IMDRF National Competent Authorities Report (NCAR) Exchange Program.
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  • 30 September 2019
  • 501
Safer Technologies Program for Medical Devices
FDA issued a draft document of Safer Technologies Program for Medical Devices on September 19, 2019 and opened for public comment until November 18, 2019.
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  • 30 September 2019
  • 707
EMA EudraVigilance Registration Manual
On September 25, 2019 EMA issued EMA EurdaVigilance Registration Manual.
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  • 30 September 2019
  • 509
New Organization First User QPPV/RP or Change of EU QPPV/RP
On September 25, 2019 EMA informed that sponsors need to notify EMA in case of new organization first user QPPV/RP or change of EU QPPV/RP.
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  • 30 September 2019
  • 466
Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorization holders (MAHs)
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP) in a no-deal Brexit.
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  • 30 September 2019
  • 480
Policy for Device Software Functions and Mobile Medical Applications
On September 27, 2019 the FDA issued this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile or on other general-purpose computing platforms.
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  • 30 September 2019
  • 9160
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
FDA issued a final guidance on Medical Device Data Systems for industry and FDA staff on September 27, 2019. The policy described in this guidance document is also consistent with the Agency’s updated guidance entitled “Policy for Device Software Functions and Mobile Medical Applications,” originally issued on February 9, 2015, with the title “Mobile Medical Applications.”
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  • 01 September 2019
  • 717
Post-marketing Safety Reporting for Combination Products
FDA issued the final guidance for industry and FDA staff on July 22, 2019
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  • 01 September 2019
  • 530
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry
The US FDA issued the final guidance on the use of placebos and blinding in randomized controlled cancer clinical trials on August 27, 2019
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  • 01 September 2019
  • 500
The National People's Congress of China issued the 2nd Revision of Drug Administration Law
The new revised Drug Administration Law of China will be effective since December 01, 2019
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  • 01 September 2019
  • 518
EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US
EMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorization decisions for new medicines
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  • 01 September 2019
  • 566
Questions Pile up for Novartis as Senators Call on FDA to Take Action
The importance of having a robust investigation process in place supported by a clear SOP and structured guidance documents on how to conduct an investigation
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  • 01 September 2019
  • 530
Guidance on substantial amendments to a clinical trial if the UK leaves the EU with no deal
U.K. MHRA Updates Information Pages in the Event of a No-Deal Brexit on August 6, 2019
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  • 01 September 2019
  • 544
What’s new in Pharmacovigilance? QPPV Update
EMA published the QPPV Update on August 1, 2019
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  • 01 September 2019
  • 492
Guideline on Clinical Investigation of Medicinal Products for the Treatment of Gout (Draft)
EMA updated this Draft with the end of consultation on August 31, 2019
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  • 01 September 2019
  • 488
ICH Global Meeting on ICH E8(R1) Guideline on General Considerations for Clinical Trials
ICH is announcing a public meeting on E8(R1), to be held on October 31, 2019 at 08:30 a.m. to 5:00 p.m. ET in Silver Spring, Maryland, USA, with Webcast option available.
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  • 01 September 2019
  • 479
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry
Comments and suggestions regarding this draft document should be submitted by October 30, 2019
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  • 19 July 2019
  • 559
Why Industry Anticipates a ‘Cliff-Edge’ Scenario with EU MDR/IVDR
Manufacturers and the European Association of Notified Bodies alike face difficult decisions with the new
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  • 18 July 2019
  • 579
Regulations on Customized Medical Device Supervision and Management (Trial Version) in China
New regulations on customized medical devices in China
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  • 17 July 2019
  • 493
German Study Finds Most New Drugs Fail to Improve on Standard of Care
Germany’s Institute of Quality and Efficiency in Healthcare (IQWiG) finds there is no evidence of added benefit for more than half of the drugs the institute assessed from 2011-2017.
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  • 17 July 2019
  • 457
Risk Evaluation and Mitigation Strategies:
Modifications and Revisions Guidance for Industry
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  • 15 July 2019
  • 557
Population
Pharmacokinetics Guidance for Industry
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  • 15 July 2019
  • 555
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent
Pregnancy Guidance for Industry
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  • 30 June 2019
  • 597
One additional country to benefit from EU-US mutual recognition agreement for inspections
Germany Joins EU-US GMP Mutual Recognition Pact
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  • 30 June 2019
  • 621
Optimisation of Safety Data Collection
This guidance is being distributed for comment purposes only
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  • 30 June 2019
  • 643
ANDA Submissions — Content and Format of Abbreviated New Drug Applications
Guidance for Industry ensuring a complete, high-quality application submitted to FDA
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  • 30 June 2019
  • 517
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
This guidance document is being distributed for comment purposes only.
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  • 30 June 2019
  • 533
Research Investigational New Drug Applications – What You Need To Know
Similarities and differences in submission requirements for Commercial and Research IND
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  • 30 June 2019
  • 597
China publishes regulation on management of human genetic resources
New rules to regulate genetic research
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  • 30 June 2019
  • 719
Guidance Document: Pre-market Requirements for Medical Device Cybersecurity
Health Canada’s new premarket requirements on medical device cybersecurity came into effect
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  • 24 June 2019
  • 649
China to stipulate the accountabilities of Marketing Authorization Holder (MAH)
China released the “Revision of the Drug Administration Law of the People's Republic of China” for public comment
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  • 17 June 2019
  • 503
China to implement new regulation for on-site inspections at the clinical sites and manufacturing facilities
National Medical Products Administration (NMPA) released “Regulations for on-site inspections at the clinical sites and manufacturing facilities” for public comment
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  • 17 June 2019
  • 614
EMA Guideline on the quality requirements for drug-device combinations
Documentation expected for Drug-Device Combinations (DDCs)
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  • 17 June 2019
  • 525
FDA Report on Pharmaceutical Quality
Product Quality of Products marketed in the USA
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  • 17 June 2019
  • 682
RWD & RWE in FDA submissions
New Draft Guideline on Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
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  • 07 June 2019
  • 656
ICH E8 under revision
The ICH Guideline “General Considerations for Clinical Trials” is under revision and has been issued for public comments
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  • 01 June 2019
  • 558
Significant advancements in global harmonization efforts at ICH’s largest biannual meeting to-date
Sixteen Members and twenty-eight Observers met in Amsterdam
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  • 21 December 2018
  • 1627
China makes switch to faster approval system for imported drugs
NMPA and National Health Commission of China have established faster system to review and approve on urgently needed new drugs that have been approved in other countries
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  • 17 December 2018
  • 1276
EMA eSource Direct Data Capture (DDC) qualification opinion issued
the regulatory acceptability to use an eSource Direct Data Capture in Clinical Trials
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  • 10 December 2018
  • 1417
EMA use of patient disease registries for regulatory purposes
Methodological and operational considerations by a cross-committee task force on Registries
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  • 03 December 2018
  • 1077
FDA Facilitates the Use of Surrogate Endpoint in Drug Development
CDER small business and industry assistance podcast news from November 2018
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  • 20 September 2018
  • 2067
EMA Draft questions and answers on Data Monitoring Committees issues
A Supplement to the CHMP Data Monitoring Committee Guideline
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  • 15 September 2018
  • 1065
EMA on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
New Draft Guideline issued; consultation end date: July 2019
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  • 10 September 2018
  • 1163
FDA Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases
New FDA Guidance for Industry
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  • 05 September 2018
  • 1033
New FDA Draft Guidance on Hematologic Malignancy and Oncologic Disease
Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development
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  • 03 September 2018
  • 1413
New FDA draft Guidance on Expansion Cohorts
Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
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  • 16 August 2018
  • 1187
CNDA seeks feedback on latest GCP Regulation Draft
The Chinese National Drug Administration (CNDA) is looking for feedback by August 16, 2018
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  • 12 August 2018
  • 1217
FDA Final Guidance for Industry: ANDA Submissions
Amendments to Abbreviated New Drug Applications under GDUFA
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  • 08 August 2018
  • 1248
FDA Announces Two Initiatives on Quality Metrics Program Development
FDA is looking for feedback on their recent Quality Initiatives on Metrics
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  • 04 August 2018
  • 1274
FDA Publishes List of Surrogate Endpoints Used in Drug Approvals
The list includes surrogate endpoints for approval of new drug applications
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  • 02 August 2018
  • 1119
EMA Policy 70 submissions temporarily suspended as of 1 August
Phase 2 of EMA’s Business Continuity Plan soon to come into effect
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  • 28 July 2018
  • 1035
Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
Publication of updated Q+As and practical guidance
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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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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

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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 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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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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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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