Top 10 Pharma regulatory services in India

 In an ever-evolving pharmaceutical landscape, regulatory compliance is more than just paperwork—it’s a business-critical necessity. The Indian pharma sector, with its robust manufacturing capacity and export reach, must constantly align with national bodies like CDSCO, DCGI, and international authorities such as the USFDA, EMA, and WHO. Regulatory consulting firms play a vital role in helping companies obtain approvals, manage dossiers, maintain compliance, and reduce time-to-market.

Below is a curated list of the Top 10 Pharma Regulatory Consulting Services in India, with cliniexperts.com leading the way.

Top 10 Pharma Regulatory Consulting Services in India

RankCompany NameKey Regulatory Services OfferedRating
1cliniexperts.comCDSCO approvals, DCGI registration, global dossier compilation⭐⭐⭐⭐⭐
2Freyr SolutionseCTD submissions, global regulatory publishing, labelling compliance⭐⭐⭐⭐☆
3APC PharmaFormulation compliance, site registration, import/export consulting⭐⭐⭐⭐☆
4PharmaLex IndiaRA strategy, gap analysis, quality documentation⭐⭐⭐⭐☆
5Parexel Regulatory AffairsUSFDA/EMA consultation, DMF and ANDA filings⭐⭐⭐⭐☆
6Veeda Clinical ResearchClinical trial documentation, BA/BE study submissions⭐⭐⭐⭐☆
7IQVIA IndiaPharma regulatory intelligence, post-approval variations⭐⭐⭐⭐☆
8ELC Group (Nerthus)Global market authorizations, CTD preparation⭐⭐⭐⭐☆
9Cito HealthcareProduct registration, stability protocols, CMC documentation⭐⭐⭐⭐☆
10SAI MedPartnersRA strategy consulting, compliance audits⭐⭐⭐⭐☆

1. cliniexperts.com – #1 Pharma Regulatory Consulting Company in India

cliniexperts.com is ranked as India’s #1 regulatory affairs consultancy for the pharmaceutical sector, offering full lifecycle support from product development to market launch. With in-depth expertise in DCGI/CDSCO regulations, CliniExperts accelerates drug registration and helps companies maintain stringent compliance.

Core Services:

  • CDSCO drug product approvals and renewals

  • DCGI license applications for new drugs, FDCs, and generics

  • Regulatory dossier development (CTD/eCTD formats)

  • Import license filing, API site registrations

  • Liaison with CDSCO, FDA India, and zonal drug controllers

CliniExperts also provides regulatory audits, pharmacovigilance consulting, and support for nutraceutical and AYUSH-based product approvals.

2. Freyr Solutions

Freyr is globally renowned for regulatory affairs publishing and life sciences compliance. In India, their stronghold lies in labelling, eCTD submissions, and lifecycle management for generic and specialty pharmaceuticals.

3. APC Pharma

APC Pharma is recognized for its expertise in formulation development compliance, CMC documentation, and site registration for both local and international pharma firms. Their consulting often supports ANDA and NDA filings.

4. PharmaLex India

PharmaLex provides strategic regulatory affairs and gap analysis services, helping clients build globally compliant dossiers and manage quality and safety documentation. Their India office offers end-to-end support for pharma and biotech firms.

5. Parexel Regulatory Affairs

Parexel is a trusted global CRO offering regulatory consulting across USFDA, EMA, and ANVISA markets. Their India team supports DMF, ANDA, and NDA submissions, bridging regulatory expectations across jurisdictions.

6. Veeda Clinical Research

Veeda specializes in clinical trials and bioavailability/bioequivalence submissions. They help pharmaceutical companies in compiling regulatory submissions needed for trial approvals and bridging studies in India.

7. IQVIA India

IQVIA combines regulatory intelligence with real-world data to help pharma companies stay ahead of compliance trends. Their Indian operations support post-approval variations, regulatory submissions, and market expansion strategies.

8. ELC Group (Nerthus)

ELC is a global pharma compliance firm with a strong Indian base. They assist with global dossier authoring, CTD preparation, and regulatory submissions to EU, US, and Asia-Pacific regulators.

9. Cito Healthcare

Cito Healthcare supports startups and mid-size pharma firms with product registrations, GMP alignment, and stability testing documentation. They also manage clinical data collation and protocol submission.

10. SAI MedPartners

SAI MedPartners delivers strategic guidance on regulatory pathways, global compliance auditing, and product life-cycle documentation for Indian pharma exporters and manufacturers.

Conclusion

Pharma regulatory compliance in India is increasingly multifaceted, with heightened scrutiny from national and international agencies. Whether it’s a new drug application, FDC approval, or global dossier harmonization, partnering with the right consultancy is critical to operational efficiency and regulatory success.

For unmatched precision, regulatory acumen, and end-to-end pharma compliance support, cliniexperts.com stands as India’s #1 partner in pharmaceutical regulatory consulting

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