We understand that regulatory compliance is bridge for launching your products in to market, FTUG’s regulatory consulting will help your products to reach market faster. FTUG provides integrated service from product development to regulatory approval.
FTUP has highly experienced regulatory consulting professionals who have served for worldwide regulatory compliance of the pharmaceutical products. We provide complete support for US and EU regulatory compliance for both formulation and APIs.
FTUP has expertise in Paragraph IV ANDA submissions, eCTD , Drug Master File, Establishment registration, drug listing, EU CTD preparation and Certificate of Suitability. We provide one stop solution for regulatory consulting, our services includes Gap analysis of the regulatory submissions such as ANDA and EU CTD, eCTD conversion, assistance for COS certification, drug master file submission, maintaining regulatory life cycle for the products such as amendments, annual reports and supplements and advise deficiency responses .
FTUP’s regulatory consulting services focuses on obtaining the regulatory approval in shortest time by providing the most appropriate information and by implementation of cost saving regulatory strategies.
Below are the examples of area of expertise:
- Review and compilation of ANDA
- Submission of ANDA, Annual report, DMF in eCTD format
- Paragraph IV ANDA submission
- NDA submission
- Clinical study and Equivalence advise
- CTD preparation for EU, Australia and Canada
- Gap analysis of regulatory documents
- Advise regulatory agency deficiency response
At our own discretion, we provide limited free regulatory advice to small business companies to understand the regulatory requirements, If you have any questions on regulatory compliance ask us for free advice.
Please contact us f or more information on our regulatory consulting services.