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- 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