Regulatory compliance is embedded into every stage of our work. MeddyPro Lifesciences supports nutraceutical and herbal products across India and global regulatory frameworks, ensuring compliance is achieved by design — not corrected later.
Our services cover regulatory pathway assessment, ingredient compliance verification, label and claim review, and preparation of registration-ready documentation across FSSAI, AYUSH, US FDA (DSHEA), EU/EFSA, GCC, and other international requirements.
Our approach integrates regulatory planning from the earliest stages of product ideation, minimizing approval delays, rework, and long-term compliance risk.
We do not treat regulation as a final checkpoint.
We believe:
- Product classification must be decided before formulation is locked
- Ingredient and dosage permissibility must be verified before positioning is finalized
- Claim boundaries must be defined before branding and marketing
- Documentation must be built for audits, not just for submission
This ensures products are defensible, scalable, and regulator-ready from the beginning.
We support nutraceutical and herbal businesses in navigating complex regulatory frameworks, including:
- FSSAI(India – nutraceuticals, food supplements, FSMP)
- AYUSH(Ayurvedic proprietary products)
- US FDA(Dietary Supplements – DSHEA)
- EU / EFSAregulatory guidance
- GCC and other international markets
Our consulting includes:
- Regulatory pathway assessment and product classification
- Ingredient permissibility and dosage compliance checks
- Claim feasibility and regulatory risk analysis
- Gap assessments and compliance audits
- Regulatory strategy for new product launches and portfolio expansion
For nutraceutical and herbal manufacturing—particularly within third-party and contract manufacturing setups—we support alignment with GMP and quality expectations relevant to dietary supplements.
Our support includes:
- Review of GMP practices and documentation
- Risk assessment related to contamination, cross-contamination, and stability
- SOP alignment for quality and compliance
- Training guidance for compliance awareness
The objective is to ensure consistent product quality, safety, and audit readiness, without unnecessary operational complexity.
We assist clients in planning and obtaining required licenses and registrations, including:
- FSSAI License & Product Approvals
- GST Registration
- Import Export Code (IEC)
- Startup India Registration
- APEDA Registration (where applicable for exports)
Support includes eligibility assessment, documentation preparation, application coordination, and compliance alignment to ensure timely and smooth approvals.
Strong documentation is critical for compliance, audits, and partner confidence. We support the development and management of pharma-grade regulatory documentation, including:
- Product dossiers and technical files
- Ingredient and formulation compliance summaries
- Label and claim substantiation documents
- SOPs, batch records, and quality logs
- CTD-aligned documentation (where applicable)
We also advise on digital document management systems (DMS) to ensure traceability, version control, and audit readiness.
For brands expanding internationally, we provide structured guidance on export readiness and destination-specific compliance, including:
- Product and ingredient adaptation for target markets
- Label restructuring and claim modification
- Documentation preparation for distributor and authority review
- Advisory on certifications and compliance requirements relevant to exports
This enables smoother international market entry while minimizing regulatory exposure.
We provide strategic advisory support on intellectual property protection relevant to nutraceutical businesses, including:
- Trademark strategy for brand and product names
- Advisory on formulation confidentiality and know-how protection
- Review of IP clauses in manufacturing, licensing, and collaboration agreements
Our focus is on protecting commercial value and competitive differentiation while supporting compliant collaboration.
We assist clients in reviewing and structuring regulatory-sensitive contracts, including those involving:
- Third-party manufacturers
- Raw material suppliers
- Distributors and export partners
Support focuses on compliance alignment, documentation clarity, and risk mitigation — ensuring agreements support long-term regulatory and commercial objectives.
Through structured regulatory compliance and documentation support, MeddyPro Lifesciences enables clients to:
- Launch products with regulatory clarity
- Reduce approval delays and post-launch risk
- Strengthen audit and due-diligence readiness
- Build compliant, scalable portfolios for domestic and global markets
- Regulatory pathway and feasibility assessment
- Ingredient and formulation compliance review
- Label and claim validation
- Nutrition / Supplement Facts panels
- Technical dossiers and compliance reports
- Early regulatory integration, not reactive fixes
- Multi-market compliance perspective
- Pharma-grade documentation standards
- Practical, regulator-aligned interpretations