Regulatory Affairs services to help you expand your market.

PharmAssure can provide Regulatory Affairs Consultants with extensive and up-to-date knowledge of registration requirements for generic pharmaceutical products in Australia, Europe, New Zealand, USA and Canada.

Our experience covers all areas from planning submissions, compilations of dossiers and response to questions. We are able to provide either consultation or outsourcing solutions for all your registration needs, including the upcoming requirements for eCTD filings.

Our regulatory services include (but are not limited to):


 

Our consultants are able to prepare a dossier on your behalf, for any of the major markets (USA, Canada, Australia, New Zealand or Europe). They will support you from the initial submission, through any deficiency responses and up to product approval.

 

Our consultants are able to review your registration strategy and advise you on the data requirements for all major markets. They can review your final application and advise on any alterations/additions that may be required to ensure acceptance.

 

Our consultants have extensive experience across the world, and are therefore well placed to provide training in all areas of regulatory affairs.

 

Please contact us with your specific request.