WHO-GMP Formulations & Dossiers

eCTD & ACTD Regulatory Dossiers for International Drug Registration

Eliminate registration delays in foreign health authorities. Akuma Enterprise Pharma provides complete, audit-validated eCTD and ACTD dossier dossiers for our entire catalog of 100 finished pharmaceutical formulations.

Direct Answer Summary: Akuma Enterprise Pharma provides turnkey eCTD (electronic Common Technical Document) and ACTD regulatory dossier dossiers for international pharmaceutical registration. Covering Modules 1 through 5, our dossiers include Certificates of Pharmaceutical Product (COPP), batch manufacturing records, analytical method validation, and 24–36 month Zone IVb stability data.

5-Module CTD Dossier Architecture

Our dossiers strictly follow ICH and WHO registration guidelines:

Module 1: Regional administrative data, application forms, manufacturing licences, GMP certificates, Letter of Authorization (LoA), and package inserts.
Module 2: Quality Overall Summary (QOS), Non-Clinical and Clinical Overviews prepared by qualified pharmacologists.
Module 3 (Quality / CMC): Drug substance and drug product specifications, process validation on 3 commercial batches, container closure systems, and batch analyses.
Module 4 & 5: Non-clinical and clinical study reports, bioequivalence (BE) reference data, and literature safety profiles.

Zone IVb Stability Validation Data

Health authorities across tropical regions (ASEAN, Africa, Latin America) require climatic Zone IVb stability studies. We conduct testing under strict ICH conditions (30°C ± 2°C / 75% RH ± 5% RH and accelerated 40°C ± 2°C / 75% RH ± 5% RH) to provide complete real-time stability reports supporting 2-to-3-year shelf life claims.

Frequently Asked Questions

Are your dossiers available in electronic format (eCTD)?

Yes. We supply regulatory dossiers in fully validated eCTD XML tree structures or formatted high-resolution searchable PDF formats per customer preference.

Can you customize the package insert and artwork for local language requirements?

Yes. Our regulatory and design teams customize carton artworks, blister foils, and package inserts (PIL) into French, Spanish, Arabic, Portuguese, and other national languages.

What is the cost and timeline for obtaining a dossier?

Dossiers are provided to contracted distribution partners upon confirmation of commercial supply agreements, typically dispatched electronically within 3 to 5 business days.

Partner with Akuma Enterprise Pharma

Connect with our commercial export and contract manufacturing desk for product catalogs, custom batch pricing, and immediate eCTD dossier review.

sales@akumaenterprises-pharma.com dalle@akumaenterprises-pharma.com

Direct Contact: +91 07986147827 · Akuma Enterprise Pharma Pvt. Ltd. · SAS Nagar, Punjab - 140301, India.