We offer Services in Regulatory Affairs as follows;
Regulatory Services
Pharma, Biotech, Medical Devices, Nutraceuticals, Herbals registrations and getting marketing approvals across the Globe
DMF, CEP, ASMF. KDMF, Technical, CMC writings. We have filed more than 500 DMF and more than 250 CEP. Camphor DMF/CEP also filed for one of the client in 2020.
Audits & PAI as per country-specific requirements
Regulatory Compilation of all modules CTD-M1, M2, M3, M4, M5 and Global Submissions (pCTD, eCTD, ACTD, NEES formats) and Technical, CMC writings, GMP Validation documentation support as per USFDA, EMA, TGA, MCC, UK-MHRA, SFDA, GCC, CFDA , RoW, Russia & CIS, Indian DCGI & CDSCO and other country-specific requirements
Sugam Portal submissions for CDSCO/DCGI
Preparation of Device Master File/technical documentation/Plant Master File
ISO 13485:2016 Certification ; ISO 9001:2015 Certification
Risk Analysis and Risk Management for all Classes of Medical Devices and IVDs as per ISO 14971 requirements
Regulatory Filing to USFDA like 510(k)
US agent and e-filing Support
CE marks, UKCA marks and All EU Registrations
Conformity Assessment
Preparation of Device Master File/technical documentation/Plant Master File