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