Regulatory Compliance

The maintenance of marketing authorisation dossier requires beside expertise also circumspection and regulatory compliance take a great deal of time. Therefore tasks are often postponed and documents become non-compliant.

We support you in updating your regulatory documents to reflect current changes (life-cycle management):

  • Classification, processing and submission of variations
  • Expert Statements
  • WHO-Certificates, CoPPs
  • Answering Deficiency Letters (LoDs)
  • Submission of PSURs (PSUR repository, eSubmission Gateway)
  • Submission of RMPs and educational material
  • Update of product information texts

What sets us apart

  • We uniquely combine operational expertise, regulatory intelligence and compliance awareness in different sections
  • CSO Pharma delivers effective services for lifecycle maintenance
  • Our Services include both pre-approval and post-approval activities ranging from review, compilation, LoD check and update proposals with focus on feasability.

Multidisciplinary expertise where it is needed most and regulatory compliance can improve processes and accelerate approvals.

We are looking forward to give you all the strategic advise and operative support needed.

 

 

 

Contact

Do you have a question - please feel free to contact us.
T +49 (0) 89 2033 53 59
F +49 (0) 89 809 193 80
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