Product Development Report Services

At Pragya Dossier-DMF Services, we offer comprehensive Product Development Report (PDR) services in alignment with CTD (Common Technical Document) guidelines. Our expert team ensures that your product's development journey is meticulously documented, covering all critical aspects from formulation design to manufacturing processes.

Our PDR services include:

• Formulation Development: Detailed documentation of the formulation process, including ingredient selection, compatibility studies, and optimization.

• Process Development: A thorough record of the manufacturing process, process validation, and scale-up studies.

• Stability Studies: Comprehensive stability data to ensure product quality over its shelf life.

• Analytical Method Development: Development and validation of analytical methods, ensuring consistency and reliability in product analysis.

• Regulatory Compliance: Preparation of reports in accordance with the latest regulatory requirements, facilitating smooth approvals from health authorities.

Trust Pragya Dossier-DMF Services for precise, regulatory-compliant Product Development Reports that streamline your path to market approval.

PDDS provide Stable, validated and BE passed technology (Formula & Process)

Right Manufacturing Process = Advantages in Export

Product technology includes:
-Batch formula, process or MFR or BMR; we also provide CDP separately on demand

PDR Report Include
3.2.P.2.1 Components of the Drug Product - Drug Substance & Drug Product
3.2.P.2.2 Finished pharmaceutical product
3.2.P.2.3 Manufacturing Process Development
3.2.P.2.4 Container closure system
3.2.P.2.5 Microbiological attributes
3.2.P.2.6 Compatibility