Facilitates Smooth Product Registration

DMFs are critical documents in the pharmaceutical industry, providing comprehensive information about the chemistry, manufacturing, and control (CMC) of active pharmaceutical ingredients (APIs). Our expertise ensures your APIs meet all regulatory standards, facilitating smooth and successful product registrations worldwide.

Critical Documentation
In Registration

DMF Compilation in CTD/
Country Specific Formats

Globally accepted standard or country specific, you name it. We ensure you meet the specific guidelines as per your requirements.

Open & Close Part DMF Writing

We prepare the shareable information part of your DMF as well as the detailed confidential aspects as per your manufacturing processes.

Review of DMF for Submission

We ensure completeness, accuracy, and consistency, correcting any deficiencies before submission to enhance your chances of swift approval.

Type II DMF Submission to US FDA

We prepare and ensure your DMF is compliant with US FDA requirements and handle the entire submission process through the FDA’s Electronic Submissions Gateway (ESG).

CEP Submission and Preparation

We assist in obtaining the Certificate of Suitability from the European Directorate for the Quality of Medicines & HealthCare (EDQM), ensuring your API’s compliance.

Canada Submission & Preparation

We support the submission of your DMF to Health Canada. Our team ensures It meets Canadian regulatory guidelines and receives timely approval.

Confused about developing a dossier for the finished product?
We provide comprehensive services in the preparation of Drug Master Files.

Facilitates Smooth Product Registration

Critical Documentation
In Registration

DMF Compilation in CTD/
Country Specific Formats

Open & Close Part DMF Writing

Review of DMF for Submission

Type II DMF Submission to US FDA

CEP Submission and Preparation

Canada Submission & Preparation

Committed To Reliable
Documentation

Robust Stability
Studies

Analytical Method
Validation

Provide Timely
Updates

Quality Control
Measures

Deatiled Manufacturing
Description

Clear, Consistent
Format

Confused about developing a dossier for the finished product? We provide comprehensive services in the preparation of Drug Master Files.

Facilitates Smooth Product Registration

Critical Documentation In Registration

DMF Compilation in CTD/ Country Specific Formats

Open & Close Part DMF Writing

Review of DMF for Submission

Type II DMF Submission to US FDA

CEP Submission and Preparation

Canada Submission & Preparation

Committed To Reliable Documentation

Robust Stability Studies

Analytical Method Validation

Provide Timely Updates

Quality Control Measures

Deatiled Manufacturing Description

Clear, Consistent Format

Confused about developing a dossier for the finished product?
We provide comprehensive services in the preparation of Drug Master Files.

Critical Documentation
In Registration

DMF Compilation in CTD/
Country Specific Formats

Committed To Reliable
Documentation

Robust Stability
Studies

Analytical Method
Validation

Provide Timely
Updates

Quality Control
Measures

Deatiled Manufacturing
Description

Clear, Consistent
Format