Preclinical Pharmaceutical Capabilities

Preclinical Pharmaceutical Capabilities

Current Capabilities:

* Process and Formulation Analysis:

  • Process and Formulation Analytical Methods Development
  • Drug Substance HPLC Purity Profiling, Stability Indicating Method Development
  • Method Validation under GLP per FDA-CDER and ICH Regulations and Guidelines
  • QA Phase Inspections and Data Review
  • DS and Drug Product (DP) Impurity Identification and Characterization
  • Stability Studies for DS/API (12-24M)
  • DS and Analytical Reference Standard (ARS) Characterization
  • GC Residual Solvent Analysis
  • Issuance of Certificate of Analysis (COA)
  • DP HPLC Purity Profiling, Stability Indicating and Assay Method Development

* Bioanalysis Studies:

  • LC/MS and CE/MS method development
  • Method validation for drugs/metabolites per FDA or ICH
  • Quantitative bioanalysis of preclinical and early clinical samples
  • COA and recertification for test substances, reference and metabolite standards
  • Metabolite profiling for cold and C-14 labeled compounds, ID and characterization
  • Metabolite isolation/enrichment by fraction collection, prep and/or semi-prep columns
  • Quantitation of test article and metabolites

* Metabolism Studies:

  • in-vivo analytical ADME services and in-life phase through a partnering company
  • in-vivo study types include mass balance, tissue distribution, metabolite profiling / radio profiling and ID, discovery PK, formulation bioavailability screening and cassette PK
  • in-vitro metabolism studies with pooled liver microsomes, hepatocytes and S9 fraction
  • Interspecies comparisons in mouse, rat, dog, rabbit, pig, monkey and human
  • P450 isozyme phenotyping

* Other Services:

  • Non-Clinical Pharmacological and Toxicological studies
  • DP Extractable and Leachable Studies
  • Dissolved O2 Analysis in DP
  • Small-scale, in-house, non-cGMP Drug Substance (DS) Synthesis
  • ARS Synthesis
  • Large-scale Synthesis Support at Manufacturing Sites
  • Developing DS and DP Specifications
  • Process Scale-Up Transfer to Manufacturing Sites
  • Product Chemistry (i.e. physical/chemical chracterization, storage stability analysis, etc.)
  • Particle Size & Surface Characterization: Particle surface, shape and area calculation by Light Microscopy Technique utilizing powerful computer software and digital camera/video

* Pharmaceutical aNDA Capabilities for Oncological Agents:

  • USP methods Transfer and Validation
  • Formulations Development
  • Formulation Stability Studies
  • Specification
  • Drug Substance and Drug Product Manufacturing Support

Regulatory Capabilities:

We are experienced in the following areas of IND Submissions for Oncological Agents:

  • Preparation of CMC Dossier
  • Preparation of Toxicology Section
  • Preparation of
  • Bioanalytical and PK Sections

Near-Future Capabilities:

* DP Development including Liquid and Gel Formulations

We have developed IND, CTX and aNDA packages for several clients. If you would like to request business references please contact us.