Training

Training Services for Dossier and Drug Master File Preparation in CTD Format

At Pragya Dossier-DMF Services, we offer specialized Training Services to help professionals and organizations master the preparation of Dossiers and Drug Master Files (DMFs) in CTD (Common Technical Document) format.

Our training programs are designed to provide a comprehensive understanding of the CTD structure and its components, including:

• Module 1: Administrative and Product Information

• Module 2: Summaries (Quality, Non-Clinical, and Clinical)

• Module 3: Quality (Pharmaceutical documentation)

• Module 4: Non-Clinical Study Reports

• Module 5: Clinical Study Reports

What We Offer:

• Hands-on Workshops: Practical, real-world exercises that simulate the preparation and submission process.

• Guidance on Regulatory Requirements: In-depth explanations of global regulatory guidelines.

• Expert-Led Sessions: Led by industry experts with extensive experience in dossier preparation and regulatory submissions.

Our training ensures participants gain the necessary skills and knowledge to confidently navigate the complexities of CTD dossier and DMF submissions, enhancing regulatory compliance and streamlining the submission process.

Key Features:

• Expert-Led Sessions: Learn from industry experts with extensive experience in dossier preparation and DMF submission in CTD format.

• Hands-On Training: Engage in practical exercises that simulate real-world scenarios, ensuring you gain practical knowledge.

• Regulatory Compliance: Stay updated with the latest guidelines and best practices for dossier and DMF submissions as per global regulatory standards.

• Customized Content: Tailored training modules that address specific needs of your organization, whether you are new to the field or looking to enhance your existing skills.

• Certification: Upon completion, receive a certificate acknowledging your expertise in dossier and DMF preparation in the CTD format.

Who Should Attend:

• Regulatory Affairs Professionals

• Quality Assurance and Control Personnel

• Pharmaceutical Scientists

• Technical Writers

• Anyone involved in the preparation and submission of regulatory documents