• L-1/286 A, Kalkaji, Ali,
    South Delhi, Delhi-110019
  • Mon - Sat 9.30am - 06.00pm
    Sunday CLOSED
  • (+91)-965 476 1239
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REGULATORY

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.

Our expertise covers:

Preparation and filing of Registration dossiers for submission to various regulatory agencies all over the world (including eCTD, CTD format & ACTD Format).

  • Compilation of dossier as per latest country specific guidelines
  • Assistance in Response to queries for submission to the Regulatory Agencies.
  • Total development of product from lab scale to pilot plant scale to actual production scale for Drug Substance and Drug product.
  • Provide analytical support in analytical method development / validation, Routine analyses of products
  • Complete stability programme management service is provided as per ICH guidelines
  • Special requirements in a cGMP and GLP compliant environment.
  • Monitoring and liaisoning with the CRO’s for Clinical and BE Studies.

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.

Our select services include:

  • Preparation,submission and interpretation of Regulatory documentation
  • Technical review and consulting
  • Technical review and consulting
  • Clinical Trial Applications
  • Vigilance and reporting systems
  • Regulatory and manufacturing compliance
  • Strategic and regulatory planning
  • Liaison with Regulatory Authorities
  • Preparation of Patient information leaflet (PIL), writing, proof reading, and user testing: for compliance with labelling laws.
  • Risk Management (ISO 14971)
  • Reviewing labeling for compliance with FDA requirements.
  • onducting audits of manufacturers to assure compliance with GMP guidelines
  • Arranging and attending meetings with Agency officials on behalf of our clients
  • Providing recall advice and assistance as needed.

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.

For Business Enquiry

For Business inquiry fill our short feedback form or you can also send us an email : info@maverickr.in and we’ll get in touch shortly, or Contact Number
(+91) 9654761239.

mavericKR Solutions is one of the world's leading management consulting firms.