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Medwisdom offers expert Regulatory Affairs Services designed to navigate the complexities of global pharmaceutical, biotechnology, and medical device regulations. Our services provide end-to-end regulatory support, from product development to market authorization and lifecycle management, ensuring full compliance with international standards such as US FDA, EMA, MHRA, WHO, TGA, CDSCO, and more.
We specialize in regulatory strategy development, dossier preparation (CTD, ACTD, eCTD), product registration, post-approval changes, gap analysis, and regulatory intelligence. Our multidisciplinary team collaborates closely with clients to tailor compliance pathways, mitigate risks, and accelerate time-to-market.
Medwisdom’s Global Regulatory Solutions are designed to support both emerging companies and established manufacturers seeking to expand into regulated markets. We bring in-depth knowledge of regional regulations and submission procedures, helping clients avoid delays and ensure smooth approvals.
Whether it’s managing new drug applications (NDAs), abbreviated new drug applications (ANDAs), medical device filings, or variations and renewals, Medwisdom provides accurate, timely, and audit-ready documentation. We also offer regulatory due diligence, labeling compliance, pharmacovigilance support, and liaison with health authorities.
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