The most important element of getting your medical device approved is the implementation of a fundamental regulatory strategy and sound technical documentation.

At RAAJ GPRAC, we help manufacturers and importers overcome the barriers in preparing strong regulatory strategies and unambiguous dossiers for filing applications for various drug products approval. We lower your administrative burden across the complete product lifecycle Our Global Regulatory Affairs team handles regulatory workflows more flexibly, productively and efficiently. From strategic regulatory advice to regulatory maintenance and lifecycle support, we’ve got you covered.

We mainly provide:

• Optimized time to key decision points
• Regulatory and operational risk mitigation
• Streamlined regulatory pathways
• Flexible approaches to generating more informative evidence earlier
• Improved transparency and proactive problem-solving

• Pharma, Biotech, Medical Devices, Nutraceuticals, Herbals registrations and getting marketing approvals across the Globe
• GxP compliance services which includes [GMP, GLP, GCP, GDP, Due diligence, Validations, CSV, Data integrity etc.
• Audits & PAI as per country-specific requirements
• Regulatory Compilation of all modules CTD-M1, M2, M3, M4, M5 and Global Submissions (pCTD, eCTD, ACTD, NEES formats) and Technical, CMC writings, GMP Validation documentation support as per USFDA, EMA, TGA, MCC, UK-MHRA, SFDA, GCC, CFDA , RoW, Russia & CIS, Indian DCGI & CDSCO and other country-specific requirements.
• Sugam Portal submissions for CDSCO/DCGI
• Preparation of Device Master File/technical documentation/Plant Master File
• ISO 13485:2016 Certification
• ISO 9001:2015 Certification
• Medical Device Registration and Approval in India with CDSCO (MD Form 5)
• Risk Analysis and Risk Management for all Classes of Medical Devices and IVDs as per ISO 14971 requirements.
• Regulatory Filing to USFDA like 510(k)
• US agent and e-filing Support
• CE marks, UKCA marks and All EU Registrations.
• Conformity Assessment.
• Getting ISI marks as per BIS (Bureau of INDIAN STANDARDS)
• Clinical Evaluation as per Meddev 2.7.1 Rev. 4 and ISO 14155 requirements