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

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  • 08 November 2013
  • 1445
Q&A on Design Space Verification
EMA and FDA publish new guidance on adhering to QbD principles:
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  • 06 November 2013
  • 1434
DIA Clinical Forum Dublin 2013
Peter Schiemann presented at the Clinical Forum in October 2013 about "A holistic Approach to Monitoring Clinical Trials". Download presentation here:
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  • 12 October 2013
  • 1619
Pharma Compliance Europe 2013
Wolfgang Beck was invited to speak at Pharma Compliance Europe 2013 about 'Service Honoraria at Fair Market Value'.
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  • 10 October 2013
  • 1489
"A Roadmap For Sharing Clinical Trial Data"
Widler & Schiemann AG invited to participate and represent ABPI at the EFPIA/PhRMA event on "A Roadmap For Sharing Clinical Trial Data"!
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  • 10 October 2013
  • 1686
EFGCP, ACRES, EORTC and UCL organize a hands-on workshop
EFGCP, ACRES, EORTC and UCL organize a hands-on workshop on how to implement a risk based approach to managing quality in clinical trials
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  • 24 September 2013
  • 1661
Swiss government approved the new ordinance regarding the Swiss clinical research law
Beat Widler was invited by the Federal Office of Public Health (BAG) to provide a critical assessment of the new ordinance. Read the article here (german):
  • 04 September 2013
  • 1449
WSQMS create Clinical Trials Disclosure Tool for ABPI
WSQMS create Clinical Trials Disclosure Tool for ABPI (The Association of the British Pharmaceutical Industry). Visit this website for further information.
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  • 04 September 2013
  • 1546
Article about Quality Risk Management in RAPS Journal
WSQMS publish Article about Quality Risk Management in RAPS (Regulatory Affairs Professionals Society) Journal. Download article here:
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  • 30 July 2013
  • 1425
Article in EFGCP news by Beat Widler
You can find all new information from EFGCP and an article by Beat Widler in their summer report which you can find at their website or in this pdf for download:
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  • 01 April 2013
  • 3916
New Website

We are glad to welcome you on our new website, designed and implemented by 3K-Webdesign

  • 01 April 2013
  • 1419
Evaluation Results of our Webinar

Our recent webinar was a success. We are very proud to present the positive feedback of our clients. Click the button below to download the Evaluation.

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  • 18 March 2013
  • 5304
You can subscribe to the WSQMS Newsletter here!


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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