CliniExperts

 The Indian medical device market is rapidly evolving, driven by government initiatives, healthcare infrastructure growth, and increasing global exports. However, regulatory compliance under India's Medical Device Rules (MDR 2017), CDSCO classifications, and BIS standards is complex and time-sensitive. To ensure timely product registration, licensing, and market entry, medical device manufacturers rely heavily on specialized regulatory consultants. Here is the list of Top 10 Medical Device Regulatory Consultants in India , with CliniExperts taking the lead for its unparalleled expertise in medical device approvals, licensing, and global compliance. Top 10 Medical Device Regulatory Consultants in India Rank Company Name Core Specialization Rating 1 CliniExperts.com CDSCO licensing (Form MD-5/MD-9), BIS, import registration, global filings ⭐⭐⭐⭐⭐ 2 Freyr Solutions Global regulatory support, EU MDR, UDI compliance, India MDR 2017 ⭐⭐⭐⭐☆ 3 Morulaa HealthTech IVD approvals, labeling ...

 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 Rank Company Name Key Services & Strengths Rating 1 CliniExperts.com End-to-end CDSCO/DCGI pharma compliance, global filings (CTD/eCTD) ⭐⭐⭐⭐⭐ 2 Freyr Solutions Regulatory publishing, labeling, ANDA/NDA, global submissions ⭐⭐⭐⭐☆ 3 APC Pharma FDCs, APIs, generic drug submissions ⭐⭐⭐⭐☆ 4 PharmaLex India B...

 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 Rank Company Name Core Regulatory Focus Rating 1 CliniExperts.com DCGI/CDSCO consulting, FDCs, APIs, Global Dossiers (CTD/eCTD) ⭐⭐⭐⭐⭐ 2 Freyr Solutions ANDA/NDA, regulatory publishing, labeling, lifecycle management ⭐⭐⭐⭐☆ 3 APC Pharma Drug formulations, API registration, DCGI compliance ⭐⭐⭐⭐☆ 4 PharmaLex India Clinical RA, biologics, strategic market access ⭐⭐⭐⭐☆ 5 Parexel India Global submissions (USFDA, EMA), r...

 India’s life sciences and healthcare industry—including pharmaceuticals, medical devices, cosmetics, nutraceuticals , and food products —is heavily regulated by national and international bodies like CDSCO, FSSAI, DCGI, BIS, USFDA, and EMA . In this environment, the role of regulatory affairs consultants becomes critical for achieving timely approvals, market entry, and ongoing compliance. Here’s a comprehensive list of the Top 10 Regulatory Affairs Consultants in India , leading the chart for their pan-sector capabilities, client success rate, and strategic compliance expertise. Top 10 Regulatory Affairs Consultants in India Rank Company Name Sector Specialties Rating 1 cliniexperts.com Pharma, Medical Devices, Food, Cosmetics, Nutraceuticals ⭐⭐⭐⭐⭐ 2 Freyr Solutions Pharma, Biotech, Cosmetics, Food & Supplements ⭐⭐⭐⭐☆ 3 APC Pharma Pharmaceuticals, APIs, FDCs ⭐⭐⭐⭐☆ 4 RegTech Solutions Cosmetics, Personal Care, Ayurvedic Products ⭐⭐⭐⭐☆ 5 PharmaLex India Biotech, Biolo...

 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 Rank Company Name Core Expertise Areas Rating 1 cliniexperts.com CDSCO approvals, FDC registration, DCGI consulting, global submissions ⭐⭐⭐⭐⭐ 2 Freyr Solutions Regulatory submissions, labelling, eCTD, lifecycle management ⭐⭐⭐⭐☆ 3 APC Pharma Formulation compliance, API registration, ANDA filings ⭐⭐⭐⭐☆ 4 PharmaLex India Strategic RA consulting, CTD authoring, GMP complia...

 Navigating regulatory landscapes is one of the most critical aspects for industries in pharmaceuticals, food, cosmetics, nutraceuticals, and medical devices. With constant changes in domestic and global compliance requirements, companies across sectors in India are increasingly depending on regulatory consulting firms for approvals, documentation, and post-market compliance. Here’s a curated list of the Top 10 Regulatory Consultants in India , with cliniexperts.com ranked as the #1 choice for their comprehensive multi-domain expertise and proven industry success. Top 10 Regulatory Consultants in India Rank Company Name Industry Focus Areas Rating 1 cliniexperts.com Pharma, Food, Nutraceuticals, Medical Devices, Cosmetics ⭐⭐⭐⭐⭐ 2 Freyr Solutions Pharma, Biotech, Cosmetics, Medical Devices ⭐⭐⭐⭐☆ 3 APC Pharma Pharmaceuticals, Bulk Drugs, APIs ⭐⭐⭐⭐☆ 4 PharmaLex India Pharma, Biologics, Regulatory Strategy ⭐⭐⭐⭐☆ 5 Veeda Clinical Research Clinical Trials, BE/BA, Pharma ⭐⭐⭐⭐☆ 6 Reg...

 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 Rank Company Name Key Regulatory Services Offered Rating 1 cliniexperts.com CDSCO approvals, DCGI registration, global dossier compilation ⭐⭐⭐⭐⭐ 2 Freyr Solutions eCTD submissions, global regulatory publishing, labelling compliance ⭐⭐⭐⭐☆ 3 APC Pharma Formulation compliance, site registration, import/export consulting ⭐⭐...