GRAS (Global Regulatory Affair Services) is started with highly motivated and experienced Regulatory Affair professional having head office in Gurgaon, India beside regional offices in EU and USA. GRAS provides comprehensive support for a sound, profitable and faster entry in the export market. We thrive on providing unique perspectives and valuable insights into the working of mature/ emerging ph
armaceutical markets, thus opening new avenues for business. We develop the regulatory strategy, arrange agency meetings, prepare and compile the questions and briefing documents; attend the meetings and manage all communication with the agencies. Since the regulatory environment is constantly changing so we provide advice on necessary adaptations to development plans and target product profiles. At the late stage of product development we are responsible for the submission of the product dossier, e.g. Marketing Authorization Applications (MAA) in worldwide including India, Europe, Newzeland, Australia, GCC, Russia, Latin America and Asia. It is our responsibility to provide the strategic regulatory framework for the submission, to advise on procedures and formats, to collect, evaluate and compile the scientific data and information on the product. We manage the communication and negotiations with the authorities. We are accountable for maintenance of marketing authorizations and are involved in the life-cycle management of a product. Our balanced approach gives you EFFECTIVE and EFFICIENT approaches to your regulatory and compliance needs. Specialties: SERVICES:
1. CTD - Quality Report, Expert Report (Clinical and non clinical)
2. Product Life Cycle Management (SPC, FI, GI, Variations, Type I and Type II)
2. Pharmacovigilance: Safety and Efficacy Report, PSUR, QPPV
3. Drug Master File (DMF)
3. Support Services
4. Bio-availability/bio-equivalence (BA/BE) studies
5. Analytical services
6. Labeling services
7. Proto-Type Formulation Development
