Biotech Law and Regulatory Advisory Services
The regulatory landscape for biotechnology—both in India and abroad—is complex and ever-evolving. For small corporations and startups, navigating these legal mandates can be a significant barrier to innovation and market entry.
At Breedington Bioindustrial Private Limited, we understand the agility and resourcefulness required of a young company (just like us, in our third year!). We offer specialized, flexible, and affordable consultancy, leveraging our team of Biotechnologists, Management Consultants, and regulatory experts to clear the compliance pathway for your product, whether you are launching in Durgapur or Dallas.
1. Services for Indian Startups & SMEs (Focus: CDSCO, DBT, GEAC)
We provide comprehensive, start-to-finish regulatory and legal support tailored to the specific requirements of the Indian biotech ecosystem. We help you achieve compliance with key agencies like CDSCO, DBT, RCGM, and GEAC.
Compliance & Regulatory Expertise
Product Classification and Strategy
Determining the correct regulatory classification (e.g., Biosimilar, New Drug, Medical Device, Novel Food) and devising the most efficient path to market clearance in India.
Biosafety & Research Approvals
Establishing your Institutional Biosafety Committee (IBSC), securing permissions for R&D, and managing compliance with the "Rules, 1989" for Genetically Engineered Organisms (GEOs) and hazardous microorganisms.
Dossier Preparation & Submission
Hands-on assistance in preparing and submitting high-quality regulatory documents to the CDSCO for Clinical Trial Applications (CTAs), Test Licenses (Form 29), and Marketing Authorizations.
Quality & Audits
Implementing and auditing GMP (Good Manufacturing Practices), GCP (Good Clinical Practices), and GLP (Good Laboratory Practices) to prepare you for inspection and long-term compliance.
Legal and Intellectual Property Advisory Services
IP Strategy & Protection:
Expert guidance on Indian Patent Act compliance, patentability searches, filing strategy, and securing Indian Patents and Trademarks for your unique biotech inventions.
Technology Transfer Documentation
Drafting and negotiating legally sound Material Transfer Agreements (MTAs), Licensing Agreements, and Joint Venture Contracts crucial for university-industry collaborations and commercial partnerships.
Corporate & Labour Law Compliance
Ensuring your startup adheres to local and national corporate mandates, labour laws, and ethical guidelines (e.g., ICMR guidelines).
2. Services for Foreign Startups & SMEs (Focus: Market Entry into India)
Are you a foreign biotech firm or startup looking to enter the lucrative Indian market? We serve as your knowledgeable, on-the-ground regulatory agent, minimizing geographical and regulatory hurdles.
Market Entry and Regulatory Facilitation
1
Regulatory Liaison
Acting as your authorized representative to communicate and file applications with CDSCO, DBT, and other relevant Indian authorities.
2
Import & Registration Support
Guiding the entire process for the import of research materials, intermediate products, and finished biotech products, including securing necessary licenses and registrations.
3
Global to India Compliance Gap Analysis
We analyze your existing US FDA/EMA/other international dossiers, identify critical gaps, and adapt your documentation to meet unique Indian data and format requirements.
Strategic & Legal Consulting
India Market Feasibility & Strategy
Providing in-depth analysis of the Indian regulatory requirements and competitive landscape for your specific product (e.g., medical device, biologic).
Legal Representation & Partnership Vetting
Vetting potential Indian partners, distributors, and contract manufacturers, ensuring due diligence, and structuring robust commercial agreements compliant with Indian law.
IP Enforcement & Local Protection
Advising on the enforcement of your existing glAdvising on the enforcement of your existing global IP in India and handling local patent and trademark filing for your brand and technology.obal IP in India and handling local patent and trademark filing for your brand and technology.
Your Feasible Partner
We are more than just consultants; we are problem-solvers who speak the language of both science and law.
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Agile and Affordable: As a startup ourselves, we offer the flexibility, speed, and competitive pricing that large, established firms often cannot match.
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Integrated Expertise: Our core team includes both scientific experts (Biotechnologists) and business specialists (Management Consultants), ensuring our regulatory advice is always technically sound and commercially viable.
Let us transform regulatory compliance from a burden into your competitive advantage.