The complexity of a registration for new products can be managed through a well-defined strategy, including step-by-step planning with full consideration of the interdependency of activities from early clinical phases through post marketing stages. 

 

ICS Maven  Associates have supported clients in Europe and North America to develop regulatory strategies that reduced the back-and-forth time between a submission and its targeted market regulatory authorities.   We tailor our support to your needs and requests; help you plan interaction with the regulatory agencies and the respective follow-ups.  Our associates assist you to prepare the submission dossier (NDA, BLA, etc.), conduct detail gap analysis, and minimize risk. 

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Regulatory  Support:

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• Regulatory approach & strategy

• Prepare BLA and NDA

• Gap analysis

• Regulatory risk management

• Interaction with regulatory authorities

• Review submission package

• Coordinate deliverable packages

• Labelling compliance review

• Submission project management

• Prepare response to regulatory bodies

• FDA meeting training/coaching

• Hands-on SME support 

• Request for orphan designation

• Request for fast track/priority review and accelerated approval

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