Scientific Advice - Protocol Assistance

Scientific Advice - Protocol Assistance.

Get the right information, first time.

Molecule discovery and creating similar molecules is expensive but rewarding if your products reach patients. We offer consultancy and support services from development to market, developing and realizing tailored strategies that fit your objectives, now and later.

Product development.

Our experts support the development and manufacture of medicines by providing expert advice and creating cost effective and successful strategies to ensure that your products will reach your targeted markets and patients.

That advice comes from years of experience and a deep understanding of ICH, GCP and GMP guidelines.

We can advise and support on:

  • Formulation development
  • Manufacturing process development and validation
  • Product specifications development and adaption
  • Dossier development
  • Labeling and artwork creation

Authority advice.

The contribution of Authorities in supporting product development and registration is important, especially when new molecules are developed or submitted.

Our experts regularly engage with authorities around the world, and incorporate our extensive regulatory intelligence resources, to create specific advice and a comprehensive and achievable product development and registration strategy. A smooth collaborative process between manufacturers, MAHs and authorities is usually a strong indicator of success.

We also support you with the preparation of product development documentation “to generate robust evidence on a medicine’s benefits and risks”, ensuring easy and accurate dossier preparation.