Regulatory Consulting

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

BSMR - Global Clinical Research Organization