Regulatory Affairs

In the pharmaceutical, biotechnology and medical devices industries, quality assurance and regulatory affairs can hardly be dissociated from each other. That’s why Quality by Design offers you the total package. We do not only take care of quality management, but also support you throughout the entire drug or medical device regulatory lifecycles. Whether this concerns traditional pharmaceuticals, generics, cosmetics, vaccines, biologicals or biosimilars, medical devices or Advanced Therapy Medicinal Products (ATMPs).

Our consultants offer comprehensive knowledge and expertise when it comes to regulatory affairs, like regulatory dossier compilation, publishing and dispatch, eCTD submissions, artwork, product labelling management, and more. We have the knowledge and expertise to support your team or to insource full regulatory affairs projects – all in an efficient and pragmatic way. Since ATMPs and medical devices are our two focal points, we support countless companies – from the pharmaceutical, biotechnology and cosmetics industry to manufacturers of medical devices.

Our regulatory affairs services include writing and structuralising registration files according to the legislation of various countries and integrating all required (technical) data. This may include:

Regulatory affairs for the pharmaceutical, biotech and cosmetics industry

  • Regulatory strategy for all markets
  • Regulatory filing
  • Support for regulatory submission
  • CMC
  • Variation/change application dossier
  • Drug Master File (DMF) and Active Substance Master File (ASMF)

Regulatory affairs for the medical devices industry

  • Regulatory strategy for EU, USA, China, Mexico and other countries
  • Support in CE marking/510K submission
  • Countries submission dossier preparation in compliance with market requirements
  • EU MDR, IVDR gap analysis, transition strategy and readiness assessment
  • Technical documentation drafting, coaching, and review in compliance with device-specific guidance and standards
  • Design control compliance coaching
  • CEP/CER preparation, coaching and compliance review
  • Dossier compliance review and gap analysis
  • Responsible persons for regulatory compliance for small companies
  • Experts reports, overview and executive summary reports

A complete solution for your company

As a knowledge company, Quality by Design offers all the experience to take care of your Regulatory affairs needs. With over 180 experts, we offer the right expertise at the right time, to support and manage your business.
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