Simple but efficient

regulatory services

Its must for any organization to have a well-defined documentation system for regulated or non-regulated market. Apt geographical knowledge is essential for smoother application process.

Developing strategies for registration of products for domestic and global markets

ecessary licenses for wide range for products including peptides, biologics, pharmaceuticals etc

Preparation of scientific advice package for agencies like USFDA, EMA, PMDA etc

all types of regulatory documents for various submissions (RCGM, DCG(I), EMA, FDA)

Templates with detailed checklist for submissions

Stage gate concept for ensuring availability of critical documents for submissions

Strategy for biosimilarity assessment and stability programs as per regulatory agency’s expectations