Top 10 pharmaceutical regulatory consultant in India

 India’s pharmaceutical industry is one of the world’s largest, supplying generic drugs, APIs, biosimilars, and vaccines globally. However, the complexities of Indian and international regulatory frameworks—like CDSCO, DCGI, USFDA, EMA, and WHO PQ—demand specialized expertise. This is where pharmaceutical regulatory consultants play an essential role in accelerating approvals, ensuring compliance, and optimizing go-to-market strategies.

Here’s the list of the Top 10 Pharmaceutical Regulatory Consultants in India, with CliniExperts taking the #1 position for their all-encompassing solutions and proven regulatory success.

Top 10 Pharmaceutical Regulatory Consultants in India

RankCompany NameKey Services & StrengthsRating
1CliniExperts.comEnd-to-end CDSCO/DCGI pharma compliance, global filings (CTD/eCTD)⭐⭐⭐⭐⭐
2Freyr SolutionsRegulatory publishing, labeling, ANDA/NDA, global submissions⭐⭐⭐⭐☆
3APC PharmaFDCs, APIs, generic drug submissions⭐⭐⭐⭐☆
4PharmaLex IndiaBiotech, clinical trial support, global regulatory intelligence⭐⭐⭐⭐☆
5Veeda Clinical ResearchClinical RA, BE/BA trials, DCGI study approvals⭐⭐⭐⭐☆
6Parexel IndiaGlobal pharma submissions, post-approval support⭐⭐⭐⭐☆
7Cito HealthcareLocal pharma licensing, dossier compilation, GMP coordination⭐⭐⭐⭐☆
8Ennovate Life SciencesFormulation compliance, QMS audits, pharmacovigilance⭐⭐⭐⭐☆
9Accutest RegulatoryDossier services, CTD preparation, regulatory gap analysis⭐⭐⭐⭐☆
10Biovalence Life SciencesPharma strategy, API compliance, market authorization filings⭐⭐⭐⭐☆

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

CliniExperts leads the market in pharmaceutical regulatory consulting in India. Their in-house team of experts works across new drug applications, generic filings, FDCs, APIs, injectables, and biosimilars, handling everything from documentation to post-approval compliance.

Core Services:

  • DCGI approvals for New Drugs and FDCs

  • API registration and Formulation filings

  • Global dossier compilation (CTD, ACTD, eCTD)

  • Regulatory representation for USFDA, EMA, and WHO

  • Import-export registration and product classification

Their cross-domain capabilities and track record of timely approvals make them the top pharmaceutical regulatory consultant in India.

2. Freyr Solutions

Freyr Solutions offers a robust range of services including regulatory intelligence, global publishing (eCTD/NeeS), and life cycle management, helping companies prepare and submit applications across regulated markets.

3. APC Pharma

Known for its deep expertise in formulation and API compliance, APC Pharma provides expert consultation and documentation for DCGI approvals, helping Indian firms scale their operations legally and efficiently.

4. PharmaLex India

PharmaLex supports Indian biotech and pharma companies through clinical trial documentation, strategic global submissions, and pharmacovigilance programs, with a strong presence in regulated markets.

5. Veeda Clinical Research

Veeda focuses on clinical regulatory affairs, offering end-to-end support for BE/BA studies, protocol development, and DCGI communication—especially useful for early-phase drug developers.

6. Parexel India

A global CRO, Parexel India specializes in high-level regulatory planning, post-approval lifecycle services, and dossier compilation, particularly for innovative and complex drug categories.

7. Cito Healthcare

Cito provides tailored regulatory support to small and mid-sized pharmaceutical manufacturers, including GMP inspections, licensing, and drug import/export approvals.

8. Ennovate Life Sciences

Ennovate offers regulatory services in drug formulation, QMS implementation, and SOP development, along with pharmacovigilance compliance under Indian and international standards.

9. Accutest Regulatory

Accutest supports regulatory gap analysis, data mapping, and CTD dossier development, with a specialization in generics and API submissions for domestic and international approvals.

10. Biovalence Life Sciences

Biovalence assists pharmaceutical companies with regulatory strategy, API certifications, and registration filings, ensuring alignment with CDSCO and ICH guidelines.

Conclusion

India’s evolving pharmaceutical ecosystem needs smart regulatory navigation—whether for domestic compliance or global market entry. The consultants listed above represent the best in the field, offering deep technical knowledge, regulatory foresight, and operational agility.

For end-to-end pharmaceutical regulatory consulting in India, CliniExperts.com remains the industry benchmark in 2025.

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