Regulatory Services

As part of the Galenica pharmaceutical services, we provide regulatory consulting. We assist you through the regulatory hurdles associated with drug development facilitating approval of submissions.

Galenica has extensive experience of the registration process within EU and US and works with you to achieve your objectives.

Our primary focus is to support the regulatory interests of Galenica clients’ including strategic planning in development, preparation and assembly of CMC sections of regulatory documents included in IMPDs and MAAs as well as INDs and NDAs.

We can help reduce your time to market and assure success by:

  • • Accurate and careful design of studies
  • • Investigating and proposing regulatory strategies
  • • Initiating early interactions/negotiations with appropriate regulatory body