Welcome to

Primera Analytical Solutions Corp.

For years, Primera has provided extensive services to pharmaceutical, biotechnology, life science, chemical, cosmetic, and dietary supplement industries in bioanalytical, analytical, formulation developments, as well as clinical trial analysis. We are committed to being a customer-focused company that cultivates long-term business relationships, in-depth research and development partnerships, and responsive, reliable, cost-effective services. We are registered with FDA and are in full compliance with GLP/cGMP regulations.

Bioanalytical analysis

Primera provides comprehensive bioanalytical services in method development, validation, and application on quantitative measurements of active pharmaceutical ingredients and/or their metabolites for non-clinical and clinical studies. We also provide in vitro metabolism services. With strong technical expertise and up-to-date regulatory knowledge, our experienced scientists and experts have helped our customers to achieve their primary objectives within specified timeframes. We take great care to ensure quality and are meticulous about details throughout the analysis. We are in compliance with FDA GLP regulations.

Analytical services

Primera specializes in customized analytical method development using state-of-the-art analytical tools, with the understanding of the unique need of various customers. Our technical know-how and extensive experience with organic, inorganic compounds, as well as biochemicals allows us to develop sensitive analytical methods to identify and quantitate bioactive substances, chemical and biochemical substances, impurities, degradants, and preservatives in a wide range of test matrices for lot release and stability assessment. We are in compliance with cGMP regulations.

Formulation development

Primera delivers high quality formulation development services including pre-clinical/phase I formulation, pre-formulation study, formulation screening, formulation testing, stability testing, bioavailability enhancement, novel drug delivery, and generic product development. Our formulation development team offers unsurpassed skill and experience in designing formulation strategy, developing and optimizing formulation methodologies and supporting analytical procedures.

Clinical trial analysis

Primera offers biostatistics, data management, and medical writing services for increased demands in clinical trial analysis and consulting. In partnership with TMC Inc., we support large and small companies in protocol design, statistical analysis plan development, production summary tables/graphs/data lists and CRF tabulations, statistical analysis, strategic consulting, data entry, data validation, query management, medical coding, and clinical study reports.