We are equal partners in the development of robust technology for the rapid entry of pharmaceutical products into the global market. We develop, validate, support implementation of analytical methodology and interpret analytical data in support of drug substance (API), pharmaceutical dosage forms (DP) and stability from early development to commercialization.
Consulting and Training Services
PharmChem Analytical Consulting provides specialized services to clients that develop pharmaceutical products. Having 28 years in the Pharmaceutical Development Industry with major companies such as G.D. Searle, Monsanto, Pharmacia, Pfizer and Theravance led to a multitude of experience covering analytical support to all dosage forms and drug substances including biologicals. Whether a short-term or an extended project, PharmChem Analytical can greatly help provide the most efficient means of expediting product development along with helping to ensure critical quality and compliance. PharmChem Analytical can provide the depth of experience and expertise that can help expedite development projects, and provide the training and systems to be successful.
Pharmaceutical Analytical Chemistry Expertise
Pharmaceutical Development - Analytical support to pre-formulation, formulation, solid state evaluation, API, excipients, impurities, degradation products.
Quality Assurance - Quality risk management, Quality by Design (QbD), Statistical Process Control (SPC), Design of Experiments (DOE)
Chromatography - HPLC, UPLC, CE, HPIC, GPC, SEC, TLC, HPTLC, GC, SFC, etc. (e.g. affinity, normal phase, reverse phase, ion exchange, ion exclusion, ion pairing, pre-column and post column derivatives, high temperature, Tandem methods, etc.)
Spectroscopy - UV/VIS, FTIR, NIR, MS, Fluorescence, Multi-Angle and Dynamic Light Scattering, Liquid Scintillation, Atomic Absorption, Inductively coupled plasma, X-ray diffraction etc.