Analytical Studies of API, Excipients, Raw Material, Final Products
Analytical support for pre-clinical drug discovery activities
- Development of qualitative and quantitative analytical HPLC, LC/MS or LC-MS/MS methods of small molecule drugs in support of preclinical drug discovery studies.
- Acquisition, processing and reporting pre-clinical and pharmacokinetic and toxicokinetic data, including ADME, protein binding and metabolites identification.
- Development of qualitative and quantitative bioanalytical LC-MS/MS methods of small molecule drugs and metabolites in biological matrices (plasma, urine, and various tissues).
- Analytical support for pharmacokinetics studies, dose formulation and dose verification, metabolite identification, stability, solubility, and other experimental needs.
- Development of extraction protocols for various biological matrices using liquid-liquid extraction (LLE), solid phase extraction (SPE) and protein precipitation techniques.
- PK data generation and interpretation for non-compartmental analysis using WinNonlin software.
- Biologics
- Lyophilization process development
- Proteins and peptides analytical methods
- Stability studies
- Small Molecules Pre-formulation and Formulation Studies
- Solubility profile
- Particle size distribution
- Drug-excipient interactions
- pH profile, log pKa
- REGULATORY CONSULTING SERVICES
- FDA, DEA, and EPA audits and submittals
- cGMP/GLP regulatory compliance and audits
- Strategists, auditors for Method Development, Validation, Transfer