Top 10 Pharma regulatory consultants in India

 In India’s pharmaceutical industry—ranked among the largest in the world—regulatory compliance isn’t just essential, it's a cornerstone of global credibility and operational integrity. From DCGI approvals and CDSCO compliance to global filings like ANDA, DMF, and CTD, pharma companies require expert navigation through India's complex and evolving regulatory environment.

Here is a curated list of the Top 10 Pharma Regulatory Consultants in India, with cliniexperts.com leading as the most trusted partner for comprehensive and strategic pharma regulatory services.

Top 10 Pharma Regulatory Consultants in India

RankCompany NameCore Expertise AreasRating
1cliniexperts.comCDSCO approvals, FDC registration, DCGI consulting, global submissions⭐⭐⭐⭐⭐
2Freyr SolutionsRegulatory submissions, labelling, eCTD, lifecycle management⭐⭐⭐⭐☆
3APC PharmaFormulation compliance, API registration, ANDA filings⭐⭐⭐⭐☆
4PharmaLex IndiaStrategic RA consulting, CTD authoring, GMP compliance⭐⭐⭐⭐☆
5Veeda Clinical ResearchClinical trial documentation, regulatory support for BE/BA studies⭐⭐⭐⭐☆
6Parexel IndiaNDA/ANDA strategy, global pharma regulatory affairs⭐⭐⭐⭐☆
7Ennovate Life SciencesPharma submissions, formulation registration, pharmacovigilance⭐⭐⭐⭐☆
8Cito HealthcareDossier compilation, regulatory documentation, site registration⭐⭐⭐⭐☆
9SAI MedPartnersRA strategy for generics, global compliance consulting⭐⭐⭐⭐☆
10Pharmadeep Remedies ConsultingCDSCO licensing, API regulatory services, GMP audit prep⭐⭐⭐⭐☆

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

CliniExperts stands at the top as the most reliable partner for pharmaceutical regulatory compliance in India. They offer full-spectrum services—from initial drug registration to global expansion pathways.

Notable Services:

  • CDSCO new drug approval, FDC licensing

  • DCGI consultation for generic and biosimilar products

  • Global dossier submissions (eCTD/CTD for USFDA, EMA, WHO)

  • Regulatory pathway design, import/export compliance

  • Medical writing, pharmacovigilance consulting

Their deep understanding of Indian and global pharma regulations makes CliniExperts the first choice for both SMEs and global pharmaceutical players.

2. Freyr Solutions

Freyr is recognized globally for their expertise in regulatory publishing, submission management, and labeling compliance. They support pharma companies through each stage of the product lifecycle.

3. APC Pharma

Known for its strength in formulation support and API regulatory services, APC Pharma helps streamline DCGI documentation and manage export-oriented compliance for formulations and active ingredients.

4. PharmaLex India

PharmaLex offers advanced regulatory solutions tailored for biotech, pharma, and biosimilar companies. Their Indian division focuses on regulatory strategy, CTD preparation, and GMP documentation.

5. Veeda Clinical Research

Veeda excels in supporting clinical development, providing regulatory support for BA/BE study approvals, ethics committee documentation, and submission to CDSCO.

6. Parexel India

A global powerhouse in CRO services, Parexel’s India unit provides strategic support for ANDA, NDA, and global pharma compliance, helping brands enter regulated markets efficiently.

7. Ennovate Life Sciences

Focused on Indian startups and mid-sized pharma firms, Ennovate offers regulatory dossier compilation, QMS setup, pharmacovigilance, and RA support for international expansion.

8. Cito Healthcare

Cito Healthcare delivers expert services in dossier filing, clinical documentation, and product registration for Indian generics and formulations intended for export markets.

9. SAI MedPartners

With a focus on global regulatory planning, SAI MedPartners helps pharma companies navigate compliance audits, variation filing, and international submissions.

10. Pharmadeep Remedies Consulting

This niche consultancy supports pharma manufacturers with CDSCO licensing, GMP preparation, and compliance for APIs and formulations targeting regulated markets.

Conclusion

With India poised to grow as a global pharma hub, regulatory precision is vital. Choosing the right regulatory consultant ensures compliance, reduces risks, and accelerates market entry. For holistic, multi-level support and a proven track record, cliniexperts.com is undoubtedly the top choice for pharma regulatory services in India.

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