About us

At Pragya Dossier-DMF Services, we specialize in providing comprehensive and high-quality dossier and Drug Master File (DMF) services in the Common Technical Document (CTD) format. With a deep understanding of global regulatory requirements, we are committed to supporting pharmaceutical companies in navigating the complex landscape of drug approval and compliance.

Our Expertise

Our team of experienced professionals is dedicated to delivering tailored solutions that meet the specific needs of our clients. We excel in preparing dossiers in CTD, ACTD, and ROW formats, ensuring that every document is meticulously crafted to meet the stringent standards set by regulatory authorities worldwide. Our services include:

• CTD Dossier Preparation: Comprehensive support in compiling and submitting dossiers in the CTD format, ensuring compliance with international regulatory guidelines.

• Drug Master File (DMF) Services: Expert assistance in the preparation and submission of DMFs in CTD format, helping our clients safeguard their intellectual property and facilitate smooth regulatory approvals.

• Analytical Method Validation: Adherence to ICH guidelines to validate analytical methods, ensuring accurate and reliable data for regulatory submissions.

• Bioequivalence Studies: Conducting and documenting bioequivalence studies in accordance with country-specific guidelines to support drug approval processes.

• Product Development Reports: Detailed and compliant reporting of product development activities as per CTD guidelines.

• Technical Document Writing: Specialized in crafting technical documents with precision and clarity, meeting the requirements of regulatory bodies.

• Clinical Trial Report Writing: Expertise in writing comprehensive and compliant clinical trial reports that align with regulatory expectations.

Our Commitment

At Pragya Dossier-DMF Services, we are driven by our commitment to excellence, precision, and client satisfaction. We understand the critical importance of accurate documentation in the pharmaceutical industry and strive to provide services that ensure our clients' success in the global market.

By partnering with us, you gain a trusted ally in your regulatory journey, equipped with the knowledge, experience, and dedication to help you achieve your goals. Let us handle the complexities of regulatory documentation so you can focus on what you do best – developing and delivering safe, effective, and innovative pharmaceutical products.