Drug Registration Services
Our Services
We provide an End-to-End regulatory services that compile, publish, and manage IND (Investigational New Drug), NDA (New Drug Application), ANDA (Abbreviated New Drug Application), DMFs (Drug Master Files), ASMF (Active substance master file procedure), CEP and also BLAs (Biologic License Applications) dossiers for global regulatory authority such as USFDA Agent Services, EMA, MHRA, GCC, Health Canada, SAHPRA, JFDA, AUTGA, SWISSMEDIC.
- eCTD Dossier Publishing & Compilation.
- Dossier QC Review and Submission.
- ACTD, CTD, and NeeS submission.
- Technical Validation of received documents.
- DMF publishing from type I to IV.
- Query response and management.
- Bookmarking and Hyperlinking as per the validation criteria.
- Document Formatting - Word Style Guides and PDF Navigation.
- Conversion of NeeS or paper dossiers to eCTD for Baseline submissions.
- Easily add new supplemental and amendments to existing Dossier applications.
- Compile file consolidated Dossier with all supplements and amendments into a single document.
- Review of quality documents like Specifications, Analytical Methods, Validation Reports and Stability Data, and Batch Records.
- Preparation and review of Reports of information required for the development of regulatory CMC.
- Life cycle management