Briging a new product from development to marketing approval is an expensive and lengthy process. If any delays occur, costs in both time and money can rapidly escalate. BSMR Regulatory team to work wit you to set and help deliver with in timelines that controls cost.
BSMR providing regulatory consulting services to Pharmaceutical, Biotechnology, and API manufacture and formulation companies.
BSMR is offering wide range of Regulatory Services:
Regulatory Submissions and approval in different countries for IND, NDA, ANDA, BLA and CTA applications
CTD/eCTD Submission
Regulatory Agency Liaison
DMF compilation for Submission to EU and USFDA in CTD format
GMP Audit services for APIs and finished manufacturing facilities