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  • 05 March 2020
  • 243
Safety Testing of Drug Metabolites
On 5 March 2020 the FDA announced the availability of the final guidance for industry.
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  • 04 March 2020
  • 236
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.
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  • 04 March 2020
  • 373
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.
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  • 02 March 2020
  • 489
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.
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  • 02 March 2020
  • 384
Orphan medicines in the EU
On 28 February 2020 the EMA published the leaflet on orphan medicines in the EU.
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  • 02 March 2020
  • 452
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.
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  • 02 March 2020
  • 474
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On 19 February 2020 the FDA announced the availability of the draft guidance for industry.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.
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  • 02 March 2020
  • 452
Good manufacturing practice
On 19 February 2020 the EMA updated the GMP guidelines.
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  • 02 March 2020
  • 381
European Medicines Agency’s Privacy Statement
On 19 February 2020 the EMA published its privacy statement for the pre-employment medical examination.
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  • 02 March 2020
  • 368
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.
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  • 01 March 2020
  • 392
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
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  • 18 February 2020
  • 412
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.
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  • 18 February 2020
  • 375
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.
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  • 18 February 2020
  • 480
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.
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  • 18 February 2020
  • 391
Substances, Products, Organisations, Referentials (SPOR)
On 11 February 2020 the EMA announced the availability of the SPOR Application Programming Interface (API) version 2 specification.
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  • 18 February 2020
  • 403
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.
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  • 18 February 2020
  • 399
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.
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  • 18 February 2020
  • 380
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.
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  • 18 February 2020
  • 421
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.
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  • 18 February 2020
  • 316
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.
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  • 18 February 2020
  • 504
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.
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  • 18 February 2020
  • 763
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.
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  • 18 February 2020
  • 362
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.
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  • 18 February 2020
  • 348
European Medicines Agency - Privacy statement for Selection and Recruitment
On 03 February 2020 the EMA updated its privacy statement for selection and recruitment.
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  • 07 February 2020
  • 668
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
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  • 31 January 2020
  • 458
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.
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  • 31 January 2020
  • 555
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.
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  • 31 January 2020
  • 398
EMA supporting small and medium-sized enterprises (SMEs)
On 28 January 2020 EMA updated supporting SMEs.
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  • 31 January 2020
  • 396
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.
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  • 31 January 2020
  • 451
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.
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  • 31 January 2020
  • 447
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.
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  • 31 January 2020
  • 461
Procedural advice for orphan medicinal product designation
On 21 January 2020 EMA updated this guidance for sponsors.
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  • 16 January 2020
  • 501
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.
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  • 16 January 2020
  • 522
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.
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  • 16 January 2020
  • 391
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.
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  • 16 January 2020
  • 427
IRIS guide for Parallel Distribution applicants
On 10 January 2020 EMA updated the IRIS guide for parallel distribution applicants.
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  • 16 January 2020
  • 363
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
  • 410
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
  • 421
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
  • 423
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
  • 425
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
  • 501
EMA Building
Orientation Guide for Industry
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  • 02 January 2020
  • 424
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
  • 415
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
  • 491
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
  • 813
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
  • 449
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
  • 435
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
  • 468
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
  • 466
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
  • 445
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
  • 395
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
  • 700
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
  • 455
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
  • 509
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
  • 514
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
  • 493
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
  • 480
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
  • 551
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
  • 527
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
  • 522
How to handle remote monitoring?
EFGCP audit working party discussed the questions regarding to the remote monitoring.
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  • 18 November 2019
  • 546
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
  • 509
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
  • 555
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
  • 585
EMA EudraVigilance Registration Manual
On 13 November 2019 the EMA published the updated EudraVigilance registration manual
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  • 18 November 2019
  • 583
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
  • 498
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
  • 456
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
  • 518
Smallpox (Variola Virus) Infection: Developing
Drugs for Treatment or Prevention Guidance for Industry
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  • 04 November 2019
  • 504
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
  • 503
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
  • 519
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
  • 570
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
  • 553
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
  • 475
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
  • 543
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
  • 456
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
  • 425
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
  • 548
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
  • 518
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
  • 631
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
  • 817
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
  • 557
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
  • 632
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
  • 783
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
  • 594
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
  • 824
EMA EudraVigilance Registration Manual
On September 25, 2019 EMA issued EMA EurdaVigilance Registration Manual.
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  • 30 September 2019
  • 607
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
  • 585
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
  • 586
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
  • 9253
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
  • 814
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
  • 602
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
  • 583
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
  • 608
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
  • 650
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
  • 619
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
  • 646
What’s new in Pharmacovigilance? QPPV Update
EMA published the QPPV Update on August 1, 2019
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  • 01 September 2019
  • 569
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
  • 573
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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Quality by Design

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As recognized experts in QRM we provide leading edge knowledge and support to clients developing and implementing a QRM approach.

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Risk-based Monitoring & Study Management

With the QbD and QRM methodologies we are in a unique position to help you design your new approach to a targeted and centralized monitoring and study management approach.

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SOP Management and Re-engineering

We have developed and successfully deployed a new approach to SOP management. Structured Content Management (SCM) allows tailoring the content of an SOP to the exact needs of each user group. With this we have created a whole set of clinical development SOPs that can easily be deployed in your company.

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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 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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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

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