GRQ Biotech Advisors
GRQ biotech advisors is a network of regulatory, compliance, and quality experts who provide innovate, science and risk-based approaches for development, approvals and lifecycle management of biologics, small molecules, and vaccines. The GRQ advisors provide expertise in drug development, pre-approval through post-approval regulatory and quality strategies, plan, and their execution. We have extensive experience in providing regulatory and quality solutions for all geographies with emphasis in USA, EU, Japan, Brazil, and China. We also provide expertise to companies located in EU, India, China, and Japan on regulatory, CMC, compliance and quality solutions for successful submission, approval and life-cycle management in USA and EU. We provide full support for IND/NDA/BLA submissions, health authority liaison and interactions. Through partnership with our extensive network of collaborators, we can provide end to end support, including authoring and publishing for regulatory filings (clinical, preclinical, and CMC).