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 services 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 or 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, LoD check and proposals for update with focus on feasibility.

Regulatory compliance, a multidisciplinary approach and updates where relevant - to improve processes and speed up changes.

Audits

Professional, reliable and meaningful audits >>

Contact

Do you have a question - please feel free to contact us.
T +49 (0) 89 458 142 36
F +49 (0) 89 809 193 80

or just send an email to