Dossier Services

Your Trusted Partner for Comprehensive Dossier Solutions

At Pragya Dossier-DMF Services, we specialize in providing high-quality dossier preparation and submission services in CTD (Common Technical Document) and ACTD (ASEAN Common Technical Dossier) formats. With extensive experience in regulatory compliance, we offer tailored solutions that cater to the specific needs of the pharmaceutical, herbal, and food product industries.

PDDS write (prepare / Draft) and review dossier as per European CTD / ASEAN CTD / ROW-CTD /non-CTD (country specific guideline)

We use latest Pharmacopoeia to prepare CTD Dossier and We strictly do not give our client prepared document to anyone and do not use other dossier data.

CTD Dossier Content

Module 1 - Administrative Information and Prescribing Information
Module 2 - CTD Summaries (Quality Overall Summary, Nonclinical & Clinical Overview)
Module 3 - Quality (S part - DMF & P Part - Finished Product)
Module 4 - Nonclinical Study Reports (Literature-Based)
Module 5 - Clinical Study Reports (Literature-Based)

Our Services

1. CTD Dossier Preparation: We offer complete CTD dossier preparation services, ensuring that your product complies with the regulatory requirements of various international markets. Our team meticulously compiles, formats, and reviews all necessary documentation to meet the stringent standards of global health authorities.

2. ACTD Dossier Preparation: Our ACTD dossier services are designed to streamline your product registration in the ASEAN region. We provide end-to-end support, from compiling technical data to ensuring compliance with regional regulatory guidelines.

3. ROW Dossier Preparation: For markets beyond the well-established regulatory frameworks, our ROW (Rest of the World) dossier preparation services provide customized solutions. We cater to diverse regulatory requirements, offering dossier preparation services that are flexible, thorough, and tailored to meet the specific needs of various countries and regions.

4. Dossier Review and Gap Analysis: We conduct thorough reviews and gap analyses of existing dossiers to identify areas of improvement. Our experts work closely with your team to enhance the quality and compliance of your submissions.

5. Regulatory Strategy and Consultation: Navigating the complex regulatory landscape can be challenging. Our regulatory experts provide strategic guidance and consultation to help you develop effective submission strategies that align with your business goals.

6. Document Management and Submission: We manage the entire documentation process, from initial preparation to final submission. Our services include electronic document management, ensuring that all files are organized, secure, and ready for submission to regulatory authorities.

Why Choose Us?

• Expertise and Experience: Our team consists of seasoned professionals with extensive knowledge of regulatory requirements across various regions. We stay updated with the latest industry trends to provide you with the most accurate and effective solutions.

• Tailored Solutions: We understand that every project is unique. That's why we offer customized dossier services that cater to your specific product and market needs.

• Commitment to Quality: Quality is at the core of everything we do. Our meticulous approach ensures that your dossiers are not only compliant but also of the highest standard.

• Timely Delivery: We recognize the importance of meeting deadlines. Our efficient processes and dedicated team ensure that your dossiers are prepared and submitted on time, every time.

Excellent Quality - All our services are customized and offered on a modular basis meeting the specific requirements of our customers. We use reference dossier (EU/US-CTD) to draft dossier.

Best Team - Our Team work in close association with our customers to deliver innovative and cost effective solutions to help maintain their competitive advantage from early stage of product development right through to licensing, manufacture in short throughout the life cycle of the product.

Unique Style of Work - We have sufficient professionals to do Job work; We allot work to experienced team; We use own customized software to organize documents

Get in Touch - Ready to take the next step in your regulatory journey? Contact Pragya Dossier-DMF Services today and discover how we can help you achieve your compliance goals with confidence.