Regulatory Affairs Department
Genelife Clinical Research has a dedicated Regulatory Affairs Department committed to streamlining the complex process of regulatory submissions. This department ensures that every clinical trial and product registration endeavor is in full compliance with the demands of global regulatory bodies — making Genelife a trusted CRO in India for regulatory strategy.
Global Regulatory Expertise
India — CDSCO/DCGI
IND applications, Clinical Trial permissions (CT permissions), New Drug Applications (NDA), and product registrations under New Drugs & Clinical Trials Rules 2019. Full CDSCO submission expertise.
USA — FDA
IND, NDA (including 505(b)(2)), ANDA, BLA, Orphan Drug applications, and pre-submission meetings. Strategy formulation even in the absence of finalized FDA guidelines.
Europe — EMA / BfArM
Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), BfArM submissions, and comprehensive EU regulatory strategy including scientific advice meetings.
Other Markets
TGA (Australia), Health Canada, MHRA (UK) post-Brexit, and other regulatory bodies — providing comprehensive global regulatory strategy for multi-regional clinical development programs.
Regulatory Services
- Regulatory Document Compilation per specific regulatory body requirements
- Strategic Regulatory Planning tailored for specific countries and pathways
- Design of optimized regulatory strategies (NDA, BLA, 505(b)(2), ANDA, Biosimilars)
- IND Enablement — evaluation, compilation, and representation before regulatory agencies
- Regulatory Intelligence and Competitive Landscape Analysis
- Gap Analysis and Due Diligence support
- Post-Marketing Commitments and Variation Management
- Regulatory Agency Meeting Preparation and Support
CDSCO-Registered CRO: With our official CDSCO registration (CRO/MH/2026/000159), Genelife Clinical Research provides credible, regulatory-compliant services recognized by Indian and international regulatory authorities — ensuring your clinical program meets all requirements as a CRO in India.