We are ISO 21001 : 2018 Certified
Common Technical Document (pCTD, eCTD, ACTD, NEES)
The electronic Common Technical Document, or eCTD, is a standard format required by Health Authorities to submit regulatory data. The importance of eCTD in regulatory affairs is that it allows to provide detailed information about drugs and medicines with the objective to obtain approval from the agencies involved in regulating the marketing authorization of medicines.
We promote advanced use of e-tools for greater productivity in the preparation and submission of eCTD using Agencies’ gateways and portals while being in direct contact with the authorities.
- MAA CTD for Europe Submission, South Africa-CTD, Australia-CTD, Kenya & Uganda CTD.
- 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.
- ACTD i.e., ASEAN CTD (Malaysia, Thailand, Philippines, Singapore, Myanmar, Cambodia, Vietnam, Indonesia, Brunei, Laos) Preparation and submission of ANVISA GMP Inspection documents, ANVISA CTD dossiers, Validation package.
- Expertise in solving the difficult eCTD/eDMF/NeeS validation warnings and errors.
