Ready dossiers, adaptable to your regulator
We give you access to registration dossiers and technical documentation from our manufacturing partners, and assist in adapting them to the requirements of the regulator in your market.
Scope
Access to ready dossiers
CTD and ACTD dossiers for finished products from partner manufacturers in India, Sri Lanka and other countries.
Drug Master Files
Type II DMFs for APIs and Type IV for excipients: the open part for your dossier and a letter of access from the manufacturer.
Gap analysis
We check the documentation against your regulator’s requirements and list what has to be added or updated.
Adaptation to the regulator
Conversion between CTD, ACTD and national formats, the regional Module 1, translations and labelling.
Data from the manufacturer
Validation, stability and bioequivalence data come from the manufacturer. Where new data is needed, we arrange it with the manufacturer and accredited laboratories.
Regulator queries and lifecycle
Answers to regulator queries together with the manufacturer, and support with variations and renewals.
Documentation available on request
Prepared by the manufacturers and their accredited laboratories. We provide access to it and adapt it to your market.
- CTD dossiers
- ACTD dossiers
- National-format dossiers
- DMF Type II and Type IV
- Letters of access
- Product development report
- Process validation
- Analytical method validation (AMV)
- Stability data
- Bioequivalence study reports
- Modules 4 and 5 (literature based)
- PSUR
- GMP certificates
- Certificates of analysis
Most requests start with a DMF
A Drug Master File holds the complete information on an API: its chemistry, manufacture, raw materials, stability, purity, impurity profile and packaging. The manufacturer keeps the closed part confidential and files it with the regulator. You receive the open part and a letter of access for your dossier. We arrange Type II DMFs for APIs and Type IV DMFs for excipients in CTD format and, on request, full technology transfer of the molecule.
How it works
Request
You name the product, the market and the regulator.
Match
We find the partner manufacturer with a suitable dossier.
Adapt
Gap analysis and adaptation to the regulator’s format.
Register
Support with submission and queries until approval.
Tell us about your project
We will come back with options and next steps.