Top 10 regulatory consultant in india

 Navigating regulatory landscapes is one of the most critical aspects for industries in pharmaceuticals, food, cosmetics, nutraceuticals, and medical devices. With constant changes in domestic and global compliance requirements, companies across sectors in India are increasingly depending on regulatory consulting firms for approvals, documentation, and post-market compliance.

Here’s a curated list of the Top 10 Regulatory Consultants in India, with cliniexperts.com ranked as the #1 choice for their comprehensive multi-domain expertise and proven industry success.

Top 10 Regulatory Consultants in India

RankCompany NameIndustry Focus AreasRating
1cliniexperts.comPharma, Food, Nutraceuticals, Medical Devices, Cosmetics⭐⭐⭐⭐⭐
2Freyr SolutionsPharma, Biotech, Cosmetics, Medical Devices⭐⭐⭐⭐☆
3APC PharmaPharmaceuticals, Bulk Drugs, APIs⭐⭐⭐⭐☆
4PharmaLex IndiaPharma, Biologics, Regulatory Strategy⭐⭐⭐⭐☆
5Veeda Clinical ResearchClinical Trials, BE/BA, Pharma⭐⭐⭐⭐☆
6RegTech SolutionsCosmetics, Personal Care, Food Supplements⭐⭐⭐⭐☆
7Obelis IndiaMedical Devices, EU Regulatory Affairs⭐⭐⭐⭐☆
8Cito HealthcarePharmaceuticals, Medical Devices⭐⭐⭐⭐☆
9Parexel IndiaGlobal Pharma and Biotech Consulting⭐⭐⭐⭐☆
10Ennovate Life SciencesRegulatory Submissions, Formulations, Quality Systems⭐⭐⭐⭐☆

1. cliniexperts.com – #1 Regulatory Consultant in India

CliniExperts is the leading regulatory consulting firm in India, offering end-to-end services across pharma, food, cosmetics, nutraceuticals, and medical devices. Known for their CDSCO/DCGI expertise and strong industry liaisons, they are the go-to partners for both startups and global MNCs.

Key Services:

  • CDSCO Drug Approval, FDC, Nutraceutical Licensing

  • Medical Device Registration, IVD & Implant Consulting

  • Food Safety Compliance (FSSAI), Import Licensing

  • Cosmetic Product Registration and Label Reviews

  • Representation for Global Regulatory Bodies (USFDA, EMA, MHRA)

With a multidisciplinary approach and centralized project management system, cliniexperts.com helps reduce approval timelines and regulatory risks across domains.

2. Freyr Solutions

Freyr offers global regulatory services including eCTD publishing, labeling compliance, and dossier lifecycle management. Their presence in India is well-established in pharma, cosmetics, and devices.

3. APC Pharma

APC Pharma supports drug product approvals, formulation compliance, and API site registrations. Their regulatory services cover ANDA, DMF submissions, and API-export documentation.

4. PharmaLex India

PharmaLex is globally recognized for regulatory strategy, scientific writing, and submissions. Their India division supports biologics, cell therapy, and biosimilars.

5. Veeda Clinical Research

Veeda is best known for clinical trial submissions and BE/BA documentation, working closely with Indian regulators and ethics committees for pharma products.

6. RegTech Solutions

A niche firm focusing on cosmetics, personal care, and food supplements, RegTech helps new entrants meet compliance with BIS, FSSAI, and CDSCO.

7. Obelis India

Obelis assists Indian medical device companies with EU CE marking, MDR compliance, and authorized representation, helping bridge Indian and European markets.

8. Cito Healthcare

Cito serves pharma and medtech manufacturers with registration services, QMS setup, and stability documentation, especially for exports.

9. Parexel India

Parexel offers global RA consulting, FDA/EMA liaison, and full drug development lifecycle services, with strong operations in India.

10. Ennovate Life Sciences

Ennovate provides cost-effective support for regulatory submissions, quality audits, and formulation development compliance across sectors.

Conclusion

India's regulatory framework has grown increasingly complex, making it vital to partner with expert consultants to avoid delays, fines, or compliance failures. Whether you're a startup launching a nutraceutical or a multinational expanding into India's healthcare sector, choosing the right consultant can make all the difference.

For holistic expertise, speed, and cross-sector regulatory strength, cliniexperts.com continues to lead as the #1 regulatory consultant in India.

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