Integrated Drug Discovery and Development Services
Our integrated offering allows clients to access multiple outsourcing choices across the research and development value chain. We offer the following services
Analytical Services
Method Development & Validation
Extractables & Leachables
Syringability, Injectability, & Inhalation Study
Manufacturer Validation
Raw Material Qualification
ICH Stability & Release Testing
Impurity Analysis & Contaminant Identification
Pre-Clinical, Clinical, & Post-Approval
Pre-Formulation & Formulation
Formulation Optimization
Solid Stage Characterization
IND & NDA Submission Support
Counterfeit Analysis
Degradation Analysis
API Analysis
USP Monograph Testing
Dissolution Studies
Overcoming Solubility Issues
Toxicology Analysis
Clinical Trial Material Manufacturing
Excipient Base Identification
Bioequivalence Analysis
Disintegration Studies
Custom Synthesis
Process R&D
Chemistry R&D and Custom Synthesis
The HDH Pharma scientific team has earned its reputation through its problem solving skills and out of the box thinking when coping with challenging chemistry.
Reaction Optimization
Synthetic route development
Feasibility analysis of synthetic pathways
Methodology studies for process development
Exploratory studies for original compound synthesis
Custom Synthesis Services:
Impurities
Building Blocks
Reference Compounds
Reaction Intermediates
Pharmaceutical Reference Standards
Building blocks and screening compounds Including:
4, 5, 6, and 7– membered heterocycles, fused heterocycles
Lipids, Carbohydrates, and Nucleosides
Pyridines, Pyrimidines, Purines, Substituted Benzenes, Pyrazoles, Osoxazoles, Oxadiazoles, Indoles and Benzimidazoles
Aza-benzimidazoles, and Azitidine, Pyrrolidine, Piperidine