eWAY-eCTD SOLUTIONS

eWAY-eCTD Solutions delivers inclusive regulatory operational services to Pharmaceuticals (FP & API), Biopharmaceutical & Healthcare, CMO & Clinical Research.

As a Pharma Industry expert, we are aware that most of the countries are slowly moving towards the paperless dossier/submission.

This change shows the transformation of the pharmaceutical industry to comply with regulatory requirements (submission in electronic format either in R-CTD, in NeeS and/or in the eCTD format as per the health authority requirements) and to make avail drug products on time to the consumer.

eWAY-eCTD SOLUTIONS

eWAY-eCTD Solutions support for dossier/submissions in non-regulated/semi-regulated/ROW countries i.e. ASEAN, CIS, AFRICAN, LATAM, MENA region, R-CTD Suite is fully compliant with;

Common Technical Document (CTD) Format

ASEAN Common Technical Dossier (ACTD) Format

Country Specific/Region Specific Format

R-CTD: Emerging market like LATAM, MENA, APAC, ASEAN, and CIS region

Type of Services

• eSubmission Management
• Document/Submission Level Publishing
• Regulatory Publishing On-site/Off-site
• Regulatory Publishing Strategy
• eSubmission Troubleshoot Assistance

Type of dosage form

• Oral Solid Dosage Form (Tablets and Capsules)
• Parenterals (Powder for Injection, Solution and Suspension)
• Topicals (Cream, Ointments and Suppositories)
• Others (Ophthalmic, Otic and Inhaler)

Type of Applications

• ANDA, NDA, BLA and IND
• MAA via CP, NP, MRP and DCP
• NDS, SNDS, ANDS, SANDS and CTA
• MAA for Generic and NCE via NP and GCC Procedure