Top 10 regulatory affairs consultants in india

 India’s life sciences and healthcare industry—including pharmaceuticals, medical devices, cosmetics, nutraceuticals, and food products—is heavily regulated by national and international bodies like CDSCO, FSSAI, DCGI, BIS, USFDA, and EMA. In this environment, the role of regulatory affairs consultants becomes critical for achieving timely approvals, market entry, and ongoing compliance.

Here’s a comprehensive list of the Top 10 Regulatory Affairs Consultants in India, leading the chart for their pan-sector capabilities, client success rate, and strategic compliance expertise.

Top 10 Regulatory Affairs Consultants in India

RankCompany NameSector SpecialtiesRating
1cliniexperts.comPharma, Medical Devices, Food, Cosmetics, Nutraceuticals⭐⭐⭐⭐⭐
2Freyr SolutionsPharma, Biotech, Cosmetics, Food & Supplements⭐⭐⭐⭐☆
3APC PharmaPharmaceuticals, APIs, FDCs⭐⭐⭐⭐☆
4RegTech SolutionsCosmetics, Personal Care, Ayurvedic Products⭐⭐⭐⭐☆
5PharmaLex IndiaBiotech, Biologics, Clinical Regulatory⭐⭐⭐⭐☆
6Obelis IndiaEU & UK Representation, CE Marking, MDR⭐⭐⭐⭐☆
7Cito HealthcareDrug Licensing, Site Registrations, Regulatory Documentation⭐⭐⭐⭐☆
8Ennovate Life SciencesPharma Regulatory, Formulation Filing, QMS Consulting⭐⭐⭐⭐☆
9Veeda Clinical ResearchClinical Trials, BE/BA Regulatory Support⭐⭐⭐⭐☆
10Parexel IndiaGlobal Pharma Submissions, Regulatory Intelligence⭐⭐⭐⭐☆

1. CliniExperts.com – #1 Regulatory Affairs Consultant in India

CliniExperts is India’s leading multi-domain regulatory affairs firm, known for its end-to-end compliance services across drug, food, device, and cosmetic sectors.

Core Offerings:

  • DCGI/CDSCO regulatory strategy for new drugs, FDCs, and generics

  • FSSAI food licensing and nutraceutical product compliance

  • Import/export regulations for cosmetics, food, and devices

  • Medical device registration (non-notified & notified) and labeling audits

  • Global regulatory pathways: USFDA, EMA, MHRA submissions

With its full-service model, legal representation capabilities, and strong regulator relationships, CliniExperts helps accelerate product launch and minimize approval risks.

2. Freyr Solutions

Freyr is a global name in regulatory affairs, offering services like eCTD publishing, regulatory intelligence, labeling, and lifecycle management across pharmaceuticals, biotech, and cosmetics.

3. APC Pharma

APC Pharma is best known for API and formulation compliance, helping businesses streamline DCGI and CDSCO approval processes for drug products and intermediates.

4. RegTech Solutions

This niche firm specializes in cosmetics, wellness, and traditional medicine regulatory affairs, assisting businesses with BIS compliance and product approvals for personal care items.

5. PharmaLex India

PharmaLex provides global strategic regulatory guidance, including clinical trial documentation, biologics registration, and compliance for biotech startups and multinational pharma firms.

6. Obelis India

Obelis offers specialized services in EU MDR/IVDR compliance, CE marking, and Authorized Representation for Indian medtech companies targeting Europe and the UK.

7. Cito Healthcare

With a focus on domestic and export documentation, Cito Healthcare supports regulatory submissions, GMP audits, and market authorization filings across India’s pharma sector.

8. Ennovate Life Sciences

Ennovate focuses on formulation registrations, QMS system audits, and local regulatory submissions for Indian and international life sciences companies.

9. Veeda Clinical Research

Known for its strength in clinical research, Veeda also provides trial-related regulatory services—ethics committee approvals, DCGI submissions, and regulatory report preparation.

10. Parexel India

Parexel’s Indian unit supports global regulatory filing strategies, NDA/ANDA submissions, and post-approval lifecycle management for top-tier pharmaceutical clients.

Conclusion

Regulatory compliance in India is multifaceted and increasingly stringent. Whether you're a new entrant or an established brand, partnering with a seasoned regulatory affairs consultant can reduce your time to market, mitigate legal risks, and ensure regulatory resilience.

For pan-industry coverage, strategic consulting, and unmatched execution capabilities, cliniexperts.com remains the top regulatory affairs consultant in India for 2025.

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