Ruchika

Global Biopharmaceutical Regulations

For over a decade, Global Biopharmaceutical Regulations Inc has helped small and medium enterprises prepare their documentation and monitor compliance of clinical and manufacturing operations. We are equipped to file with US-FDA, EMEA, MHRW and K-FDA. We negotiate clinical design and relevant end-points with the FDA and other appropriate international agencies. COMPANY CERTIFICATION AND LICENSES Licenses: ISO 9000: 2008 Lead Auditors and Auditor; ISO 13485 Lead Auditors and Auditor; ISO 14644 Auditors; (all expire Q12012); CQA and CQE Certificates: Regulatory Certificate for US; EU; Canada (renewed every 5 years) GBR is also certified as an SDB 8(a) firm and a Woman Business Enterprise DIFFERENTIATORS What differentiates Global Biopharm Regulations from other firms in this space is our niche. We work only in the functional area of regulatory and Quality. We are very strong in auditing international supply chain and what makes our audit reports remarkable is our interview of Subject Matter Experts (SME). We have in-country language capability for India and China, so we directly interview all SMEs. When we prepare regulatory dossiers, we cut down on the number of revisions and editing time. CLIENTS WE SERVED Novartis Vaccine & Diagnostics, NIH-NIAID, Dr. Reddy's Lab, Questcor Pharmaceuticals, Quantametrix, Ardea Biosciences Spectrum Pharmaceuticals, Children's Hospital USC, Ipsen, MedImmune Vaccines, Proteolyx