Regulatory Affairs Consultancy

RAHE Life Science provides integrated regulatory and commercialization support to pharmaceutical companies, biotechnology firms, medical device and IVD manufacturers, healthcare startups, and research institutions.

Our service portfolio includes:

• NSWS portal registration, Know Your Approvals (KYA), and regulatory application support.
• CDSCO regulatory submissions, including applicable CT forms, Form 29 procedures, new drug and clinical trial permissions.
• Ethics Committee(EC)/Institutional Ethics Committee(IEC)/ Indepdence Ethics Committee Registration support and permission
• Pharmaceutical and biotechnology product registration, import licensing and manufacturing-related regulatory support.
• Medical device and IVD registration, import licensing, clinical investigation and manufacturing licensing support.
• Import and export registrations, IEC assistance, export NOCs, Free Sale Certificates and applicable regulatory documentation.
• Regulatory documentation for research, testing, examination, analysis and product development.
• In-licensing, out-licensing, technology transfer, product acquisition and commercialization support.
• Regulatory due diligence, dossier preparation, submission coordination and regulatory query management.
• Assistance with country-specific regulatory strategies and international market access planning.

Our objective: To help innovators, manufacturers, research organizations, and healthcare businesses navigate regulatory requirements, establish strategic partnerships, and facilitate compliant product development and commercialization in India and international markets.