Custom Research & Manufacturing (CRAM)
PDH offers its clients a full range of new product development and product lifecycle services, ranging from R&D feasibility assessment through commercial validation and full manufacturing. PDH has an experienced in-house R&D team that assist customer’s develop new products and technologies, leveraging their extensive experiences in the various particle processing and spray technologies.
The technical support we provide our customers includes the following:
Instrumented tablet studies
Research & Development stability studies
Preliminary taste panel evaluations
DMF and other regulatory support documentation
Technical Service Reports applicable to specific formulations
PDI has adopted a best practices, Quality by Design (QbD), approach for new drug product development based on ICH Q8R standards.
This 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, including price points and inactive ingredient limitations
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