Top 10 pharma regulatory consultants in india

 India has emerged as a global leader in pharmaceutical innovation, production, and export. However, navigating India’s stringent regulatory framework—including CDSCO, DCGI, and global bodies like USFDA, EMA, and WHO—requires strategic expertise and compliance mastery. That’s where regulatory consultants play a pivotal role.

This article presents the Top 10 Pharma Regulatory Consultants in India, with CliniExperts holding the top position for its full-spectrum regulatory services and unmatched success in pharma approvals.

Top 10 Pharma Regulatory Consultants in India

RankCompany NameCore Regulatory FocusRating
1CliniExperts.comDCGI/CDSCO consulting, FDCs, APIs, Global Dossiers (CTD/eCTD)⭐⭐⭐⭐⭐
2Freyr SolutionsANDA/NDA, regulatory publishing, labeling, lifecycle management⭐⭐⭐⭐☆
3APC PharmaDrug formulations, API registration, DCGI compliance⭐⭐⭐⭐☆
4PharmaLex IndiaClinical RA, biologics, strategic market access⭐⭐⭐⭐☆
5Parexel IndiaGlobal submissions (USFDA, EMA), regulatory strategy⭐⭐⭐⭐☆
6Veeda Clinical ResearchBE/BA studies, clinical trials, regulatory documentation⭐⭐⭐⭐☆
7Cito HealthcareDrug product registration, DCGI submission, dossier compilation⭐⭐⭐⭐☆
8Ennovate Life SciencesGMP consulting, formulation compliance, pharmacovigilance⭐⭐⭐⭐☆
9Accutest Regulatory ConsultingGlobal RA documentation, CTD formatting, dossier management⭐⭐⭐⭐☆
10SAI MedPartnersDrug lifecycle management, international RA pathways⭐⭐⭐⭐☆

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

CliniExperts leads the field as India’s most trusted pharma regulatory partner, supporting clients across formulations, APIs, injectables, biosimilars, and new drugs.

Key Offerings:

  • CDSCO and DCGI licensing

  • FDC approval, API registration, and drug import/export compliance

  • Global dossier creation (eCTD, CTD, ACTD)

  • Strategy for USFDA, EMA, WHO PQ filings

  • Pharmacovigilance, legal metrology, and labeling audits

Their integrated approach ensures seamless market entry and lifecycle compliance, making them the #1 choice for pharma businesses in India and abroad.

2. Freyr Solutions

Freyr provides advanced regulatory publishing, labeling, and strategic submissions support for global pharma and biotech companies. Their presence in multiple countries strengthens cross-border filings.

3. APC Pharma

A strong domestic player, APC Pharma specializes in DCGI consultation, API registration, and formulation submissions. Their precise documentation and strategic know-how support fast-track approvals.

4. PharmaLex India

This global consulting firm offers tailored support for clinical regulatory affairs, biologics, and complex submissions in India and regulated markets like the US and Europe.

5. Parexel India

As a global CRO, Parexel India supports end-to-end regulatory services, including ANDA, NDA, and post-marketing surveillance, backed by a robust global network.

6. Veeda Clinical Research

Veeda is a specialist in clinical trial regulatory services—including approvals for BE/BA studies and protocol documentation aligned with Indian and ICH-GCP standards.

7. Cito Healthcare

Focused on SMEs, Cito Healthcare offers hands-on support in drug registration, site audits, and regulatory correspondence with Indian and foreign health authorities.

8. Ennovate Life Sciences

Ennovate provides regulatory filing, QMS audits, and post-approval variation filings. Their experience includes regulatory planning for fixed-dose combinations and orphan drugs.

9. Accutest Regulatory Consulting

Accutest delivers high-quality dossier writing, data gap analysis, and submission management tailored for global pharmaceutical standards.

10. SAI MedPartners

SAI MedPartners focuses on product lifecycle regulatory strategy, especially for generics and branded generics seeking approval in global markets.

Conclusion

With regulatory frameworks becoming more dynamic and globally harmonized, having a knowledgeable partner is essential to avoid delays, fines, or rejections. Each consultant on this list brings unique strengths, but CliniExperts.com remains the standout for its cross-domain expertise, success rate, and strategic advisory.

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