SCORP Pharma also has a strong arm in serving as Regulatory Affairs consultant. We have highly experienced qualified staff to support our clients needs for Regulatory requirements and Product registration process in various regulatory countries like US, EU, AU, CA and other regulated and non-regulated markets. As we origin from India, we also supports our client for product registration in India. We have elite and skilled employees, who gradually well understand needs and requirements of regulatory authorities norms that enlighten our clients need for product registration.
We are expertise in the following areas:
- Active Pharmaceuticals Ingredients (API)
- Generic Formulation (Tablets, Capsules, injections etc.)
1) Compilation and Submission of Drug Master File to US/EU/CA/AU/Other countries as per respective Regulatory norms.
2) Response to Regulatory and customer queries.
3) Submission of DMF as per Regulatory requirement.
- Electronic Submission (eCTD)
- NeES Submission
- Conversion of Paper submission to Electronic/NeES format.
4) Preparation of Applicant Part and Technical Package for customers.
5) We have experts team for
- CEP Application to EDQM
- EDMF Submission to EU Countries (National/Centralized/Decentralized/Mutual Recognization Procedures)
- DMF Submission to USFDA
- DMS Submission to Canada
- ASMF Submission to Australia, China, Brazil, Mexico, Taiwan, Thailand and other countries.
6) Preparation of Documents for Domestic registration like Manufacturing License, Product inclusion certificate, State GMP, WHO GMP, COPP, etc.+ Read More