Regulatory Affairs

Life Sciences Expertise

Business & Decision Life Sciences brings Regulatory and Compliance expertise throughout the product life cycle. We have a broad knowledge of the different regulations applicable depending on products specifications, in different domains and countries.

Our assets:

  • Strong expertise in specific knowledge: regulations for pharma products, bio products, food products, and registration, licensing life cycle management, regulatory strategy and compliance management.
  • Clinical-Market expertise (ethic committees, market specific requirements, target populations), MAA, post-medical devices and healthcare products.
  • A deep understanding of market specific regulatory requirements, whether national or international (EMEA, LATAM, FDA).
  • Full area of activities and technical functions including regulatory development (writing, review, authority exchanges, submissions MAA submissions.
  • Ability to cover all modules on the eCTD.
  • Data tools implementation for regulatory purposes.
  • Deep comprehension of the different terms used between authorities and laboratories.


Why choose us?

Quality-Driven
Business & Decision Life Sciences has several years of experience with multiple clients to ensure their products comply with the current manufacturing practices, regulations and legal requirements.

Customer-Focused
We work closely with our partners to deliver the best RA solutions on time, while keeping up to date with national and international legislation, guidelines and customer practices.

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