Our Testing Services

A: Pharmaceutical Analysis/Testing

Time is essence in quality control testing. PDTRC is well equipped with the personnel and equipment to meet your company’s needs. Utilizing the brightest academic ideas and scientific solutions to provide more flexible and R&D-intensive solutions for your drug development needs including the following:

• Analytical Method Development and Validation
• Qualitative and quantitative drugs testing/ analysis
• Physical and Physico-chemical determinations
• Limit tests (Heavy metals, Ash, and Anions)
• In-Process materials testing
• Finished Products Testing
• Impurity, Metabolite and Degradation Product Identification and testing
• Organic volatile impurities/Residuals solvents
• API Testing (USP/NF, EP, BP, JP)
• Quality control Release Testing
• Dissolution Testing/ profile
• In Vitro Release Rate Studies
• Stability Studies testing

B: Microbiological Testing

PDTRC offers wide range of Microbiological Testing services including:

• Sterility Testing
• Bacterial Endotoxin Testing
• Microbiological Assay for Antibiotics
• General Microbiological Testing (Coliform, Aerobic, E-Coli, Salmonella, Yeast/Mold)
• Microbiological testing of water
• Efficacy of disinfectants

C: Stability Testing

PDTRC’s dedicated stability team provides services to demonstrate how the quality of an active pharmaceutical ingredient or medicinal product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the active pharmaceutical ingredient or a shelf life for the medicinal product and recommended storage conditions. Stability studies includes.

• Stability studies protocol/ design
• Shelf life stability of the product
• Long term, accelerated and intermediate stability studies
• Stress testing of API (To identify likely degradation products)
• Freeze and Thaw Stability Studies
• Formulation Evaluation Stability Study
• Formulation Capability Study

D: Bioequivalence Center

PDTRC understands Bioavailability/Bioequivalence and has the type of expertise you need in a CRO partner to assure your study is done right. PDTRC has a strong SOP driven culture and ensures compliance with all statutory and mandatory requirements. We provide our clients a dedicated Project Management team to serve as a single, knowledgeable point of contact and a dedicated Business Development team that is involved and able to assist in all aspects of your bioequivalence studies.

• Fasting Bioequivalence Studies
• Food Effect Bioequivalence Studies
• Multiple dose and Steady State Studies
• Pharmacokinetics of single dose
• Relative Bioavailability and Absolute Bioavailability