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Regulatory Affairs
Regulatory Affairs

Empowering your compliance journey from concept to market

Regulatory Affairs

Regulatory Affairs

Regulatory Affairs

Enovalife offers regulatory and compliance expertise throughout the product life cycle. We have in-depth knowledge of the various regulations applicable to different product types (e.g., drugs, medical devices, cosmetics) and geographic regions (Europe, US, APAC, LATAM, Africa & Middle East).

Our assets

  • Strong expertise in specific regulations: Extensive knowledge of regulatory requirements for pharmaceutical products, biologics, and food products, as well as lifecycle management for registration and licensing, regulatory strategy, and compliance.
  • Clinical-market expertise: Comprehensive understanding of ethics committees, market-specific requirements, target populations, Marketing Authorization Applications (MAA), post-market requirements for medical devices, and healthcare products.
  • Market-specific regulatory knowledge: Expertise in both national and international regulatory standards (EMEA, LATAM, FDA).
  • Comprehensive regulatory capabilities: Support for all technical functions, including regulatory development (authoring, review, authority interactions, and MAA submissions).
  • eCTD compliance: Proficiency in covering all modules of the eCTD (electronic Common Technical Document).
  • Regulatory data tools implementation: Skilled in the implementation of data tools for regulatory purposes.
    • Extensive experience in drafting and submitting new product applications or variation requests.
    • Expertise in CMC (Chemistry, Manufacturing, and Controls) Module 3.
  • Deep understanding of regulatory language: Familiarity with the specific terminology used by different regulatory authorities and laboratories.
Regulatory Affairs

Why choose us?

Quality-driven approach

With years of experience across multiple clients, Enovalife ensures products meet current manufacturing practices, regulations, and legal requirements.

Customer-focused

We work closely with our partners to deliver the best Regulatory Affairs solutions on time, staying up to date with national and international legislation, guidelines, and customer practices.