Regulatory services and support

Our regulatory affairs team provides unmatched support for clients during development/pre-approval and post-approval for dossier maintenance. Our experience with various regulatory bodies and close relationship with your drug’s development team, make us easy to work with and can help you get to market quickly.

Since our inception, we have applied an open, transparent approach to our interactions with global regulatory agencies, maintaining close contact throughout the entirety of the programs we support to ensure compliance from the start. We begin the dialogue as soon as initial data is available, thoroughly communicating what it is we are aiming to achieve, how we plan to achieve it and the scientific rationale behind our methodologies.

This honest, science-driven approach provides regulatory authorities with the contextual knowledge to understand the evolution of your project and prevents costly delays at critical phases of development. The vast experience in our Regulatory Affairs/Regulatory CMC team gives us the ability to offer clear, independent and optimal advice on the ideal regulatory strategy for our partners.

We can support

  • Dossier authoring services including IMPD/IND (phase 1/2/3) and MAA/BLA (registration) stages
  • Regulatory publishing and submissions to FDA, EMA and other health authorities
  • Regulatory consulting and advice on technical, clinical and preclinical topics
  • Preparation and conduct of health authority meetings (briefing book authoring, team coaching)
  • Clinical support (e.g. clinical labelling, review of key clinical documents)

Our regulatory support does not finish at drug approval. We offer post-approval compliance review of dossiers, as well as maintenance throughout the dossier lifecycle, such as change and renewal applications submitted to the relevant authorities.

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Let’s collaborate and create quality biologics together.

Get in touch for more information.