Pharmarov Consulting partners with clients at any stage of their pharmaceutical journey. This may be from conception of a new medicine, development of the product, tech transfer to contract manufacturing organisations, clinical studies, submission of a dossier, pharmacovigilance and post-approval licence maintenance including variations.
Our regulatory approach will provide critical analysis to allow the client to understand those aspects that require addressing immediately, issues that have the potential of developing at a latter stage, and pitfalls that may need to be addressed following submission to appropriate regulatory bodies.
Due to our unique collaboration with a number of generic pharmaceutical developers, manufacturers and clinical research sites we are able to manage an end-to end service for clients looking to develop a generic product, take it to tech transfer and perform appropriate bioequivalence or clinical trials prior to regulatory submission.
Strong understanding of the working practices within national regulatory agencies along with the know-how of how regulatory decisions are made, allow us to provide the right interpretations of guidance and be able to discuss and resolve issues with regulatory agencies as soon as they are encountered.
The company possesses an extensive array of quality, clinical and non-clinical consultants to call upon.
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