A team of 30+ regulatory experts capable of undertaking regulatory filings in CTD format in many Regulated and Emerging markets based out of India, UK and Australia.
Expertise in successful management of market authorization registration process across multiple regions with different regulatory environments.
Proven track record of obtaining market authorizations in markets like UK, Rest of Europe, Australia, New Zealand, Canada, Far East Asia, Latam and Africa including South Africa.
Provide Regulatory support for customers existing and new business.
Regulatory team is competent in preparing CMC, Pre-clinical, Clinical, Product Information (SPCs/Package Inserts (PIs), Labelling, and Patient Information Leaflets (PILs) through Regulatory Strategic Planning, Management and Compliance.
We have expertise in post approval Market Authorization maintenance, Variation filing and Renewals.