Regulatory Services

End-to-end regulatory support to companies throughout the development phase, strategy to execution, applying deep understanding of the product and its development program for advice, management, writing, reviewing and submission of regulatory documents and management of regulatory interactions.

TheRAssist supports the whole spectrum of bio-pharmaceutical companies, from early stages startups to well-established commercial companies. 

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Including:

• Regulatory strategy for product development throughout its lifecycle
   

• End-to end preparation and management of meetings with Regulatory Authorities

  • Pre-IND, Type C, Special Protocol Assessment (SPA), End of Phase I / II, pre-NDA/BLA and End of Review meetings with the FDA

  • Scientific Advice, Protocol Assistance and Oral Explanation meetings with EMA.
     

• Preparation and submission of regulatory dossiers:

  • IND, NDA, BLA, IMPD, MAA, amendments and supplements

  • Fast track and breakthrough therapy applications

  • Orphan designation application
     

• Regulatory support of CMC, pre-clinical and clinical activities

  • Review of study protocols, reports, and validations

  • Preparation and review of investigator’s brochure
     

• Collaboration with experts, consultants, and local representatives
   

• Training and mentoring of regulatory affairs associates