Regulatory Services

NextPharma has the expertise to assist you in development and registration phases of your products with particular focus in scientific regulatory affairs and registration documentation. NextPharma has a broad experience on chemistry, manufacturing and quality control areas.

As your flexible strategic outsourcing partner, NextPharma offers the following regulatory services:

1. CMC Documentation
   
   • Coordination of the compilation of the CMC part
   • EU
     
     • CTD  Module 3
     • QOS  Module 2.3
     • IMPD
     • Veterinary  Part 2 & expert report part 1C.3 / Quality
     • CE mark
   • Reformatting of dossiers
   • Assessments & Variations / Amendments
   • Updating of old dossiers
   • Submission & follow-up of procedures
   • Liaison to Regulatory Authorities
   We can also help in the submissions of INDs, NDAs and ANDAs in the United States.
2. Consultancy and Regulatory Support