Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced.
Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed.
Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies.
Quality Compliance testing is done a wide variety of raw material and finished product forms including High Potent Active Pharmaceutical Ingredients (APIs), Raw Materials and Excipients, Powders - Capsules/Semi-solids, Oils - Oral Solutions and Syrups, Liquids, Vitamins, Minerals, and Nutritional, Natural Health Products (NHPs) – Powders, Herbals – Suspensions, Finished Pharmaceutical Products (Tablets, Capsules/Semi-solids, Oral Solutions and Syrups, Gels, Creams and Ointments, Powders, Suspensions, Transdermals etc.
Bioanalytical Services for Preclinical and Clinical Studies covers Method Development, Method Validation, Lead Optimization Studies, Pharmacokinetic (PK) Analysis, Bioavailability Studies, Bioequivalence Studies, Dose Formulation Analysis, Clinical Kit Preparation, Sample Handling and Management, GCP Bioanalytical Services. Bioanalytical Technologies including Liquid Chromatography - Mass Spectrometry, Inductively Coupled Plasma – Mass Spectrometry, Capillary Electrophoresis and Nuclear Magnetic Resonance Spectroscopy and Bioanalysis of PEGylated and other Polymer-Linked Drug Assays.
“Bioavailability” refers to the extent to which a drug/nutrient reaches its site of action or a biological fluid such as blood that has access to its site of action.
CRO’s offer wide range of bionalysis services in medicinal chemistry which includes bioequivalence studies. They are experts in bioanalysis for bioequivalence studies in collaboration with the sponsor and/or the selected clinical phase center. It has a long list of validated bioanalytical methods and when not available, it performs the method validation free of charge for clients in a very short period of time. Moreover, many CRO’s also have a well-reputed service provider for the full management of bioequivalence studies thanks to strategic alliances with reliable GCP compliance clinical phase centers.
Drug Development Services / Drug Discovery Services include Contract Pharmaceutical Formulation Development Services, Contract Pharmaceutical Preformulation Development Services, Medicinal Chemistry Services / Medicinal Pharmaceutical Chemistry, Preclinical Pharmacology Services, Preclinical Drug Efficacy Testing and Modeling Services, Preclinical Pharmaceutical Screening Services, Preclinical Pharmacology Services by Therapy Type, Preclinical Study Design Services (Contract CRO), Preclinical Testing Services, Analytical Method Development Services, Analytical Method Validation Services, Drug Metabolism Pharmacokinetics Services (Contract DMPK Services), Pharmaceutical ADME Testing Services (Absorption, Distribution, Metabolism, Excretion), Pharmaceutical ADME-Tox Services (in vitro ADMET Services), Pharmaceutical Biomarker Testing Services / Biomarker Services, Pharmaceutical Contract Bioavailability Testing Services, Pharmaceutical Contract Bioequivalence Testing Services, Pharmaceutical Contract Drug Interaction Testing Services, Pharmaceutical Pharmacodynamics Testing Services (CRO), Pharmaceutical Pharmacogenomics Testing Services (CRO),Preclinical Toxicology Testing Services (in vitro) etc.