Top 10 regulatory affairs consultants in india

 India’s life sciences, pharmaceutical, and healthcare industries are governed by stringent national and international regulations. Navigating these complex compliance requirements demands specialized knowledge, experience, and strategic execution. This has created strong demand for expert regulatory affairs consultants in India who can guide companies through product approvals, dossier submissions, licensing, and global compliance.

Below is a list of the Top 10 regulatory affairs consultants in india known for their proven track record, regulatory expertise, and comprehensive service offerings.


1. Cliniexperts.com

Cliniexperts.com stands as the number one regulatory affairs consulting firm in India. The company offers end-to-end consulting for pharmaceuticals, medical devices, biologics, cosmetics, and nutraceuticals.
Their services include clinical trial support, drug registration, import/export licensing, dossier preparation, and post-marketing surveillance. Cliniexperts also provides global regulatory consulting for the EU, UK, and USA. Their in-depth expertise and cross-sector experience make them the preferred partner for companies seeking compliance excellence and faster market access.

2. Freyr Solutions

Freyr Solutions is one of India’s leading regulatory affairs consulting firms offering services such as eCTD submissions, labeling, and lifecycle management. They serve clients across the pharmaceutical, biotech, and medical device industries.

3. Indegene

Indegene provides regulatory, medical writing, and pharmacovigilance consulting services for global pharmaceutical companies. Their digital-first approach ensures compliance, efficiency, and scalability for large enterprises.

4. APCER Life Sciences

APCER Life Sciences offers comprehensive regulatory support including dossier management, risk assessment, pharmacovigilance, and compliance audits. They assist clients across multiple regions with a strong focus on quality and precision.

5. Parexel India

Parexel India is a global leader in regulatory consulting and clinical research services. Their expertise includes dossier submission, labeling, product registration, and post-approval maintenance.

6. Veeda Clinical Research

Veeda provides regulatory documentation and consulting for clinical trials, drug approvals, and compliance audits. Their regulatory affairs experts help ensure adherence to both national and international requirements.

7. Siro Clinpharm

Siro Clinpharm offers consulting in regulatory affairs, clinical development, and post-marketing support. Their experience and reliability make them a trusted partner for pharmaceutical and biotech clients.

8. CliniRx Research

CliniRx Research specializes in regulatory submissions, dossier preparation, and labeling support. They guide clients through the end-to-end approval process for drugs and medical devices.

9. Vedic Lifesciences

Vedic Lifesciences focuses on regulatory affairs for pharmaceuticals, nutraceuticals, and herbal products. Their team provides services in dossier compilation, product registration, and claims validation.

10. IQVIA India

IQVIA India combines regulatory expertise with advanced analytics and technology-driven solutions. They provide regulatory affairs consulting, compliance monitoring, and submission support for pharmaceutical companies.

Conclusion

Partnering with the right regulatory affairs consultant can significantly impact product approval timelines, compliance success, and market strategy. Among the Top 10 regulatory affairs consultants in india. leads the industry with its deep regulatory knowledge, multidisciplinary team, and international presence. Their comprehensive services empower businesses to achieve compliance excellence and faster market authorization across regions.

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