Regulatory Compliance

The maintenance of regulatory documentation often requires not only expertise but also judiciousness - and regulatory compliance takes up a large part of the time.

Current tasks are quickly postponed and documents then become non-compliant. We support you with implementation of changes and updates to adapt your regulatory documents to current version and standards.

Our life cycle management service include:

  • Classification, processing and submission of variations
  • WHO certificates, CoPPs
  • Responding to deficiency letteres (LoDs)
  • Submission of PSURs (PSUR repository, eSubmission Gateway)
  • Submission of risk management plans and educational material
  • Review and update of product information texts

What distinguishes us: We combine operational expertise, regulatory intelligence and compliance awareness.

Our services include both the pre-approval and the post-marketing activities: from review, compilation and LoD check to an comprehensive update with focus on feasibility.

Regulatory compliance, multidisciplinary approach and updates where relevant.

For further information, please feel to contact us.

Our Services

Your needs and objectives are our central focus during implementation. To achieve this inspiring goal we combine >>


Ensure compliance - we take care and ensure correctness, completeness and up-to-dateness of your product information in the article 57 database >>