PD Holdings, LLC is a specialty particle processing and delivery form technology expert for Pharma, OTC and Nutritional product applications.

Services

Contract Manufacturing

We look forward to develop your new product or extend the life cycle of your existing product right from R&D feasibility assessment through commercial validation and full manufacturing. Our experienced in-house R&D team can assist you to leverage your ideas and plans to make your product launch a success.

The technical support we provide our customers includes the following:

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  • Instrumented tablet studies
  • Stability studies
  • Formulation assistance
  • Taste Panel Evaluations
  • DMF documentation
  • Technical Service Reports 

Quality by Design (QbD), approach for new drug product development based on ICH Q8R standards.

 

QbD process is managed internally through the following key phases:

Target Product Profile (TPP) – client input that accurately describes the end product and its ideal requirements
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Determine Critical Quality Attributes (CQA’s)
Link raw material attributes & process parameters to CQA’s and perform Risk Assessment
Development of a Design Space
Design & Implement a Control Strategy
Manage Product Lifecycle Opportunities, including Continual Improvement