At Medwisdom Lifescience, we provide regulatory affairs consultation combined with strategic planning to simplify your path to product approval. Our team—including former FDA managers, NDA application reviewers, and seasoned industry experts—is dedicated to delivering simple, reliable, and effective regulatory solutions that overcome compliance hurdles and challenges.
We specialize in providing transparent and efficient regulatory consultation to help you mitigate potential delays and meet your goals on time. Our services cover preparation of CTD, ACTD, and eCTD dossiers for product registration in compliance with global standards.
We support brand pharmaceutical products as well as generic drugs, preparing and submitting key FDA-required documents such as:
Deep expertise • Indian regulatory mastery • Global compliance success
Our experienced team possesses in-depth regulatory knowledge covering pre-clinical studies, Chemistry, Manufacturing and Controls (CMC), and clinical trials across diverse therapeutic categories — including biologics, vaccines, small molecules, and advanced therapy medicinal products (ATMPs) such as gene therapy.
We offer project-specific regulatory strategy and complete lifecycle support, guiding your product from early development stages through to successful market authorization and commercialization.
Medwisdom Lifescience is a trusted name in Indian regulatory affairs with strong insight into global regulatory landscapes. Our strategic approach identifies, analyzes, and aligns with requirements — enabling seamless compliance for Pharmaceuticals, Medical Devices, Cosmetics, Nutraceuticals, and biologics.
With expert knowledge of Indian regulations — including the Drugs and Cosmetics Act 1940, Rules 2020, and Medical Device Rules 2017 — combined with native language proficiency and authorized agent status, we deliver accurate, efficient, and commercially valuable regulatory outcomes.
We offer a wide range of regulatory affairs consultancy services in India as mentioned below:
Comprehensive support for pharmaceutical product registration and compliance in India.
Full assistance for medical device licensing, registration, and compliance through CDSCO and related portals.
Complete regulatory support for cosmetic import, manufacturing, and post-market compliance in India.
MedWisdom Lifescience provides expert regulatory guidance to help you achieve fast, compliant product approvals globally.
Contact UsRegulatory Affairs Consulting involves expert guidance to help companies in pharmaceuticals, cosmetics, medical devices, and nutraceuticals successfully register and maintain their products. Our consultants resolve regulatory queries, prepare compliant dossiers, and ensure timely approvals from authorities worldwide.
We provide regulatory consultancy services primarily for:
We offer a full range of regulatory services including:
We provide global regulatory support with strong expertise in:
We also specialize in Indian regulations (CDSCO, Drugs & Cosmetics Act).
Timelines vary depending on product type, country, and complexity:
We provide realistic timelines after reviewing your product and target markets.
Yes. We offer complete post-approval services including:
We help ensure long-term regulatory compliance and market success.
