Strong technical team with >20 years of experience of delivering 100+ early phase and 30+ commercialized products at global pharma
Molecule-Material-Medicine (MMM) driven formulation strategy expertise in enabling preclinical formulation development
Specialize in mini-tablet pediatric formulation
QbD-based versatile and strong agile manufacturing capability
Leverage all business units within Crystal Pharmatech
Top-of-the-line equipment and notch instruments for DS/DP characterization and formulation technology
cGMP facility and QMS that met NMPA, FDA, and EMA regulatory requirements
One-stop shop from preclinical to commercial manufacturing
Integrated clinical formulation development process from bulk manufacturing to packaging and supply
For biotech, Crystal Pharmatech offers practical, innovative, cost-effective and comprehensive solutions from early development to GMP manufacturing. By utilizing our Molecule-Material-Medicine (MMM) approach, we work diligently with you to move your molecule to medicine faster with optimal API formulation and form.
● Clinical info and needs
● DMPK understanding
● Pharmacodynamics
● Safety info
● Molecular profile
● API phase
● API physiochemical,
biopharmaceutical, mechanical
properties and stability
● Excipient functionality, physical
attributes, compatibility
● Properties of formulation
tailored for process
● Label as driver for design
● Interaction of composition and
process
● Impact of API(s) and excipients
properties and composition on
CQA
● Impact of CPP on CQA
● Control strategy for drug product
