The increasingly complex Medical and Pharmaceutical regulations and requirements of local health authorities, and the need to remain abreast of rapid changes in global and local markets, demand dedicated teams of consultants and an organization focused firmly on the healthcare sector.

MCPL is one of the leading India based consultancy firm which offers regulatory solutions to the all key healthcare sectors, including,

  • Facility Development:
    • API Manufacturing (WHO, USFDA, EU GMP, TGA, PICs etc)
    • Formulation Manufacturing(WHO, USFDA, EU GMP, TGA, PICs etc.)
    • Medical Devices and Invitro Diagnostic Devices (Indian Medical Devices Rules 2017, ISO 13485 etc.)
  • Regulatory Services for Pharmaceuticals, Medical Devices, Diagnostics, Biologicals, Veterinary health care etc.

We provide consistent, high quality and cost effective consulting in the areas of regulatory, clinical, safety and manufacturing.

Ways we can help our clients includes

Regulatory Guidance

The overall quality of any regulatory application is largely dependent on an understanding of the requirements and its degree of compliance with relative regulatory guidelines or policy. Our experts knows how to evaluate product data and according to that they guide our client’s for different regulatory applications. We help our client in the aggregation of numerous data sources, followed by appropriate analysis, filtering and interpretation to produce a range of defined outputs.

Regulatory Communications

We have a proven history of effective communication with the different regulatory authorities in India. As a regulatory consultant we ensures that messages received from the regulatory agencies are interpreted and understood correctly, to ensure that issues raised are adequately addressed, without unnecessary waste of time and resources.

Regulatory submissions

We will help you in the preparation and submission of regulatory dossiers across all key healthcare sectors, including pharmaceuticals, biotech, medical devices and generics. We just not transmit the dossiers to the regulatory agencies but also proactively follow them up, identifying and responding to questions and issues as they arise. For more detail about different types of regulatory services offer by MCPL, please refer our services section listed on this website.

Regulatory Training

MCPL provides a broad range of regulatory training programs which are tailored to an organization’s precise, individual needs. We help our client in learning and understanding most aspects of regulatory affairs and operations.

Apart from these, if you would like more information please /contact us and we will be happy to explore with you how we can best help you.

Why to choose us?

  • Over 20Years of extensive regulatory consulting experience
  • Backed by competent and well Qualified Team of regulatory consultants
  • In depth understanding of Indian Regulatory Systems (State, Zonal and Central) as well as of regulations on special pharmaceutical products viz medical devices, rDNA based biotech products, orphan drugs, vaccines and combi-vaccine and blood derivative products.
  • Ability to develop and maintain partnership with various Indian and multinational companies.
  • Ability to identify needs of clients and complete the assignment on time and on budget.
  • Immediate & Truthful advice and service.

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