Services
Regulatory Services
Medicon Lifesciences regulatory consultancy is an Indian based pharmaceutical regulatory resides in Vadodara Gujarat India. Medicon Lifesciences is also involved in a wide variety of regulatory consulting assignments which related markets e.g., USA, Europe, Canada, Australia etc. and less regulated markets e.g. India, Asia Pacific, CIS, Middle East, Africa and so on.
Medicon Lifesciences is a regulatory affairs consulting firm having expertise in submission and approvals for USA, EU and Emerging markets and expertise in filing and approvals of ANDA, NDA, NCE as well as branded Generic products across the globe. As well as we provide regulatory, product development expertise and resources, through all stages of product development to enhance submission preparation and achieve faster product approvals, leading to enhanced access to markets and opportunities. Medicon Lifesciences is Helping customers understanding regulatory requirements along with developing and implementing strategies leading to first cycle approvals in India.
Medicon Lifesciences is a regulatory affairs consulting firm having expertise in submission and approvals for USA, EU and Emerging markets and expertise in filing and approvals of ANDA, NDA, NCE as well as branded Generic products across the globe. As well as we provide regulatory, product development expertise and resources, through all stages of product development to enhance submission preparation and achieve faster product approvals, leading to enhanced access to markets and opportunities. Medicon Lifesciences is Helping customers understanding regulatory requirements along with developing and implementing strategies leading to first cycle approvals in India.
We can help you by assisting you in the following areas:
Our services include-
- Development, preparation, assembly and submission of complete Common Technical Documentation (CTD) for marketing authorization applications (MAAs) in both Europe and the USA.
- Orphan drug designation/applications
- Conversion of paper or NEES documents into electronic dossiers using e-CTD (electronic Common Technical Document) software
- Preparation of responses to regulatory authorities, comment letters, and assessment reports
- Provision of support for scientific advice meetings, representation to regulatory agencies and meeting planning
- Preparation and submission of European clinical trial authorization (CTAs) and ethics committee applications
- Risk management plans
- Due diligence and data evaluations.
- Preparation and submission of DMFs and ANDAs (CTD & eCTD formats) Facilitation for the timely approval of DMFs and ANDAs
- We evaluate and facilitate the resolution of complex exclusivity issues involving generic and branded products Domestic & International Expertise
- We undertake the regulatory work of Pharmaceuticals, Biologics, Medical Devices and Food Industry
- We perform due diligence audits of applications in association with the sale of pharmaceuticals
- Preparation of Dossiers for various markets
- Review of the existing dossiers for improvements