Due Diligence of the Company and Applicant

We also provide complex services to meet specific and unique needs of our clients which include the due diligence of any company, applicant or dossier.

We Provide

  • Company Audits with full report about company compliance, challenges, and potential threats
  • Comprehensive assessment of the manufacturing processes, data management, cGMP compliance of the manufacturing site
  • Review of regulatory dossier with focus on gap analysis, dossier updates requirement and regulatory affairs submission strategy for new submissions as well as contract manufacturing transfer
  • Evaluation of all legal requirements for newly set up organization or start up in case of required status of marketing authorisation holder utilizing all potential business advantages e.g SME
  • Post inspection clients support for reorganization, process remodeling with focus on demonstration of quality compliance

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