mavericKRoffers a wide range of services and guidance for all size pharmaceutical companies inthe areas of regulatory affairs and Patents around the globe. As the global pharmaceutical market is constantly evolving, wehelp our clients to overcome thechallenges with highest level of professionalism and integrity. We are committed to navigate you through all regulatory hurdlesin an ethical and socially responsible way. Our team consists of industry trained regulatory professionals having invaluable pharma experience that aims to commercialize the product in both time and cost-effective manner.We constantly thrive upon to bring out transparency, accountability and uniformity in our services in order to ensure safety, efficacy and quality of our client’s product.
We support our clients by guiding the product development according to the country specific requirements, data generation, document compilation for submission to various Regulatory Agencies globally and coming out with regulatory strategies to enter new markets.
Preparation and filing of Registration dossiers for submission to various regulatory agencies all over the world (including eCTD, CTD format & ACTD Format).
Wecan work with you, for you or justprovide you expert regulatory, clinical and compliance services pertaining to Pharmaceutical medical device,Biosimilars,herbals and cosmeceuticals as these markets are highly competitive and ever growing.
MavericKR complements your organization by providing client tailored guidance on the matters of diverse product profiles and submissions for review and endorsement by the authorities such as FDA and other International Regulatory Authorities,Retrieving various legal documents from Local FDA such as Product Permission,Loan license, Certificate of Pharmaceutical Product (COPP), and Free sales certificate.Furthermore, we provide assistance on import procedures, import registration and assisting in obtaining clearance of products.We assist in getting Permission of Import registration as Finished formulation, API (Bulk drug), Cosmetics, Vaccines, Medical devices, Import NOC (Form 10), Import Test License and Export services such as B.E report, Clinical Trial report, B.E Export N.O.C, Embassy Attestation and Export N.O.C.