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EMA Services: Regulatory Operations

Regulatory operations is a critical component of the submission process. At ProPharma group, we have developed the expertise to meet our client demands at all levels. We have in-house publishing capabilities, allowing our client to make their annual mandatory and development submission timelines.

Further, we work with our clients to monitor their various submissions, keeping calendars, and working with the regulatory authorities to make sure critical deadlines are met. We routinely collect the data and prepare annual reports, process safety updates and in general, make sure our clients are in compliance with the laws in all of the countries in which they operate.

We support our clients with activities such as:

Submissions and Procedural Management

Dossier Compilation and Publishing

Submission Management

Act as Local Contact Company/Health Authority

 

 

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