At Genentech Regulatory Solutions LLP, we provide end-to-end regulatory guidance, documentation, and compliance support across the biotechnology, food, feed, biopharma, clinical research, industrial biotech, and biodiversity sectors.
Our services are designed to help industry, academia, and startups navigate India’s complex regulatory landscape with clarity, accuracy, and confidence. From biosafety and clinical trial submissions to strain dossiers, FSSAI approvals, biodiversity compliance, and capacity-building programs, we offer science-driven, practical, and reliable solutions tailored to your specific needs.
| Service Area | Who Needs This | What We Offer | Regulators Involved & Deliverables |
|---|---|---|---|
| Biotech & Bio (Safety/Security) Regulation | Research labs, biotech companies, startups, institutional biosafety committees |
|
Regulators: DBT, IBSC, RCGM, GEAC Deliverables: IBSC documents, GE microbe dossiers, risk assessment reports, biosafety SOP set, facility audit report |
| Food & Feed Regulatory Support | Food-tech firms, enzyme manufacturers, feed producers, ingredient developers |
|
Regulators: FSSAI, BIS Deliverables: FSSAI dossiers, safety data pack, label compliance sheets, claims evaluation reports |
| Biopharma & Clinical Trial Regulatory | Pharma companies, CROs, hospitals, research institutions |
|
Regulators: CDSCO, DCGI, CTRI, IEC/IRB Deliverables: IND package, protocol documents, ethics submissions, regulatory response drafts |
| Industrial Biotechnology & Fermentation | Fermentation industries, precision fermentation startups, enzyme/bioproduct manufacturers |
|
Regulators: DBT, GEAC, CPCB/SPCB Deliverables: Strain dossiers, process regulatory documents, ZLD/waste compliance reports, scale-up documentation |
| Biological Diversity Act (BDA) Compliance | Industries using biological resources, research institutions, foreign collaborators |
|
Regulators: NBA, SBB (State Biodiversity Board) Deliverables: ABS forms & filings, compliance dossiers, risk assessment documents |
Our proprietary workflow ensures a structured, accurate, and successful pathway to regulatory approval.
We begin with a detailed understanding of your product, technology, or research activity. This includes:
Based on the assessment, we design a tailored regulatory roadmap that aligns with your timelines, resources, and market needs. This includes:
We work closely with your team to prepare all required scientific, technical, and regulatory documents, including:
We manage the end-to-end submission process, ensuring accuracy, compliance, and smooth communication with regulatory authorities. This includes:
Our engagement continues after submission, ensuring long-term success. We provide:
We deliver solutions built on trust, transparency, and expertise.
Clear steps, structured milestones, and regular progress updates ensure you always know where your project stands.
Choose from fixed-fee packages or customizable project-based models that suit your timeline, budget, and scope.
Work closely with experienced regulatory scientists, domain experts, and documentation specialists throughout your engagement.
Your data, documents, and proprietary information are handled with strict confidentiality, secure systems, and full regulatory compliance.
We provide clear deliverables designed to meet real regulatory requirements—no unnecessary complexity.
Whether you're in biotech, food, pharma, or industrial fermentation, our process adapts to your specific regulatory needs.
Proven track record of successful regulatory support and strategic partnerships
Developed a Detailed Project Report (DPR) on India's emerging cell and gene therapy business landscape.
Provided regulatory guidance for CAR-T Cell Therapy, including licensing pathways, strategy, documentation, and IND-related support.
Supported FSSAI regulatory submission for non-animal whey protein under non-standardized/novel food categories.
Provided comprehensive regulatory and biosafety support to Novozymes SEA and its industrial clients using genetically modified yeast for large-scale ethanol production. Responsibilities included IBSC constitution and compliance support, preparing and submitting interim regulatory communications, development of Risk Assessment & Risk Management (RARM) documentation, liaison with RCGM and GEAC for regulatory approvals, and oversight of containment, facility readiness, and site compliance for production-scale operations.
We have supported documentation, regulatory preparation, protocol review, submission strategy, and compliance support for multiple Phase I–IV clinical studies across infectious diseases, biologics, vaccines, antimicrobials, devices, and post-marketing surveillance.
Let our expert team guide you through the complex regulatory landscape and ensure your success.
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