Making the correct designations of ‘active substance starting materials’ in a chemical synthesis can be very difficult but is extremely important to your company. There is a subjective element to overcome and only a limited set of rules to help you with the decisions. These will be discussed and some examples considered in our comprehensive CTD Module 3 course in London on 2 – 3 July 2013.
The impact of the designations on GMP compliance with regard to development costs and to the time taken to gain regulatory approvals of Marketing Authorisation applications can be huge, so increasing your understanding of the many issues is more than sensible! Please hurry to book if you want to secure a place. Bookings close soon.
DRUG REGULATORY AFFAIRS INTERNATIONAL 