Supportive Services

At Pragya Dossier-DMF Services, we specialize in providing Technical Document Writing Services in compliance with the Common Technical Document (CTD) guidelines. Our expertise lies in meticulously preparing comprehensive and well-structured documentation that meets regulatory standards and ensures smooth approval processes.

Our team of experienced professionals ensures that every document is crafted with precision, clarity, and adherence to the specific requirements of regulatory authorities. Whether you need assistance with Module 1 (Administrative Information) or the intricate details of Modules 2-5, we offer tailored solutions that align with your product’s needs.

Our Technical Document Writing Services include:

• Module 2 Summaries: Expert preparation of quality overall summaries, nonclinical overviews, and clinical summaries.

• Module 3 Quality Documentation: Detailed documentation of the manufacturing process, control of drug substance and product, and other quality-related aspects.

• Module 4 Nonclinical Study Reports: Comprehensive reporting of nonclinical study data, ensuring compliance with regulatory expectations.

• Module 5 Clinical Study Reports: Preparation of clinical study reports with a focus on clarity, accuracy, and regulatory requirements.

List of Documents:
SmPC, PIL, Pack Insert
BMR, PDR, PV, AMV / MFR
COA, MoA & Spec - FP, RM and PM
Stability - Protocol & Report
M2-Overviews, M4, M5 (with literature)
PSUR, CT and BE Report

With Pragya Dossier-DMF Services, you can be assured of high-quality documentation that facilitates your product’s journey from development to market approval.