Regulatory Support
Wehavea proven history of effective communication with various regulatory authorities in India. As a regulatory consultant, we ensure that communications received from regulatory authorities are interpreted and understood correctly to ensure that the issues raised are adequately addressed without unnecessary waste of time and resources. Our team guides organizations to understand the Regulatory guidelines and helps in correcting the issues that are raised by regulatory authorities
The overall quality of any regulatory application depends largely on the understanding of the requirements and the extent to which they are consistent with the relative regulatory guidelines or policies. Our experts know how to evaluate product data and, accordingly, orient our customers to various regulatory applications. We help our client to add numerous data sources with the subsequent analysis, filtering, and interpretation appropriate to obtain a series of specific results.
We will help you prepare and submit regulatory documents in all key health sectors, including pharmaceuticals, biotechnologies, medical and universal devices. We simply do not transfer files to regulatory authorities, but we also closely monitor them, identifying and answering questions and problems as they arise. For more information on the various types of regulatory services offered by MCPL, see our services section on this website.
We offer a wide range of Regulatory Programs that adapt to the specific individual needs of the organization. We help our clients learn and understand most aspects of regulatory issues and operations.
We possess capabilities for preparing ANDA in CTD, Technical Dossiers and Drug Master Files (DMFs) for a range of products
CostaricaPharma’s Regulatory Support indulges in analyzinga few case studies. Our insight in Regulatory Case Study and White papers:
Case study 1:Designing new operating model
Case study 2: Optimising Processes
Case study 3: Labelling Update Process Improvement
Case study 4: Creating an Outsourcing Solution
Regulatory Supplies
We will help you prepare and submit regulatory documents in all key health sectors, including pharmaceuticals, biotechnologies, medical and universal devices. We simply do not transfer files to regulatory authorities, but we also closely monitor them, identifying and answering questions and problems as they arise. For more information on the various types of regulatory services offered by MCPL, see our services section on this website.
Regulatory:
We possess capabilities for preparing ANDA in CTD, Technical Dossiers and Drug Master Files (DMFs) for a range of products
