Regulatory Services
India's regulatory pathways — decoded, navigated, cleared.
Regulatory approval is often the hardest step between a validated product and a market launch. Our regulatory team helps pharma, nutraceutical, cosmetic, and AYUSH companies navigate India's approval ecosystem — CDSCO, FSSAI, AYUSH, BIS — with clear timelines, complete dossiers, and proactive regulator communication.
What's included
Everything you need, nothing you don't.
CDSCO licensing
Drug licenses, manufacturing, import, and clinical trial approvals under the Central Drugs Standard Control Organisation framework.
FSSAI licensing & compliance
FSSAI registration, state and central licenses, product approvals, and labelling compliance for food and nutraceutical products.
AYUSH licensing
Manufacturing licenses and product approvals for Ayurvedic, Siddha, Unani, and Homoeopathic products.
BIS certification
Bureau of Indian Standards certification support for applicable product categories.
Dossier preparation
Technical, safety, and efficacy dossiers prepared to regulator-accepted formats, with scientific literature support.
Regulator communication
Query responses, deficiency replies, and structured follow-through with regulator offices until approval is granted.
Program options
Multiple tracks. One tailored plan for you.
Government filing fees are separate from our professional fees. Each engagement begins with a complimentary pathway assessment call.
FSSAI licensing
Food & nutraceutical — registration, state/central licenses, label compliance.
CDSCO licensing
Pharma — drug license, manufacturing, import, clinical trial approvals.
AYUSH licensing
Ayurvedic, Siddha, Unani, Homoeopathic product approvals.
BIS certification
Bureau of Indian Standards for applicable product categories.
Export documentation
COPP, free-sale certificates, and export-specific filings.
Fee Structure
Regulatory fees — mapped to the pathway your product needs.
Regulatory approval costs depend entirely on your product category (pharma, food, nutraceutical, AYUSH, cosmetic) and the pathway required. We start every engagement with a free 30-minute pathway assessment — you leave with a clear map of approvals needed, timelines, and total cost.
- Free pathway assessment — 30 mins, no obligation
- Total cost breakdown — our fees + govt. fees + timelines
- State & central licenses handled end-to-end
Government filing fees (CDSCO, FSSAI, AYUSH, BIS) are separate from our professional fees. Regulator approval timelines are variable; we commit to responsive filings and timely query responses, but regulator decisions are beyond our control.
FAQ
Common questions.
Which product categories do you cover?+
Pharmaceuticals, nutraceuticals, food supplements, cosmetics, and AYUSH (Ayurveda, Siddha, Unani, Homoeopathy) products. For medical devices, we assess case-by-case.
How long does regulatory approval take?+
Highly variable — FSSAI registration can take 30–60 days, while CDSCO drug approvals can take 6–18 months depending on category. Timelines are shared after our initial pathway assessment.
Do you guarantee approval?+
No one can ethically guarantee regulatory approval — decisions rest with the regulator. We guarantee complete, compliant filings and proactive follow-up that give your application the strongest possible chance.
Can you help with export approvals?+
Yes — for products being exported from India, we assist with COPP (Certificate of Pharmaceutical Product), free-sale certificates, and export-specific documentation.
Get started
Ready to launch? We'll map your regulatory path in 48 hours.
Share a few details and our team will reach out within 24 hours with a tailored plan, syllabus, and fee structure — no obligation.
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