We provide DossierMgmt, SPL/SPM Global eCTD format conversion services and solutions. We deliver the best quality services to our clients, regardless of the complexity of the requirements. We are well known for our expertise and quality of work. We work in a timely manner though various milestones to deliver the expected results on time.
We quote the most competitive price for our services, based on the market research and quality work
eCTD Services
USFDA
ANDA, IND, NDA, BLA, DMF, Originals, Amendments, Annual report Submissions, Labeling Supplement Submissions, Periodic Adverse Drug Experience Report (PADERS), eCTD baseline Submissions
European Medicinal Agency
MA, Originals, Variations, Renewals, ASMF, CEP, PSUR with Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), National Procedure (NP)
Health Canada
Regulatory activities for Division 1 human drugs can also be filed in eCTD format. We support NDS, SNDS, ANDS. Module 1 Specifications in both the formats, version 2.2 and Validation Criteria version 5.0
Gulf Cooperation Council
MA, Renewals of MA, PSUR, Variation Type 1, Variation Type 2
Swizz Medical Council
Initial submissions, Responses,
Variations
South Africa health and products regulatory affairs
Initial submissions, Responses, Variations
Therapeutic Goods Administration Austrailia
Initial submissions, Responses, Variations
Thai Food and Drug Administration
Initial submissions, Responses, Variations
Therapeutic Goods Administration Austrailia
Initial submissions, Responses, Variations