Analytical development

Understanding of your drug substance, drug product or manufacturing process can only be achieved through experienced analytical studies and robust analytical data. Our team provide a full method design, development, and review of early-stage analytical methods for assisting early-stage dosage form development as well as the design, development, and review of analytical method qualifications, preparing validation protocols and reports as per ICH / USFDA requirements.

To support route scouting and process development activities and to accelerate your clinical programs, we provide a comprehensive range of analytical services. Our analytical development and Quality Control teams have in-house access to a comprehensive range of state-of-the-art analytical techniques. We provide full stability studies alongside our analytical and quality control teams. We offer a full service of design, development, and review of early-stage analytical methods for assisting early-stage dosage form development as well as the design, development, and review of analytical method qualifications, preparing validation protocols and reports as per ICH / USFDA requirements. We provide full stability studies alongside our analytical and quality control teams.

Characterization studies

Obtaining the optimal physical form for your API is important as this impacts downstream product performance. Optimizing characteristics such as size/shape, particle size distribution, flow, density, bioavailability and melting point enables more efficient formulation and manufacturing process development at the drug product stage.

Formulation studies

We provide support and in-depth characterization expertise related to the development and stability assessment of all types of oral solid dosage forms. We have comprehensive experience and competence within the dry powder inhalation field and have assisted in progressing inhalation projects.

Method development and validation

Analytical method development and validation is critical to development and achieving the reliable analytical data you need to reach your next development milestone. Our team is updated on current regulatory expectations and relevant chemistries that provide you with the best method and validation plans combined with our advanced instrumentation resulting in accurate, reliable analytical methods.

Impurity profiling

Our team provides expert determination and identification of residual solvents to help ensure that residual solvents have been reduced to acceptable levels in drug products, drug substances and excipients. We have extensive experience in working with ICH Q3C or USP <467>. We support your project by following the ICH Q3D guidance risk-based approach to assessing the presence of elemental impurities in drug products.

Genotoxic pharmaceutical impurities

Pharmaceutical genotoxic impurities analysis services delivered from our GMP laboratories to support the identification, quantification and control of genotox impurity levels in APIs or drug products to meet regulatory expectations. Our services are supported with the preparation of toxicological risk assessments.

Stability studies

We provide ICH pharmaceutical stability storage and testing across the development and lifecycle of pharmaceutical products. These allow the evaluation of active pharmaceutical ingredient (API) or drug product stability under the influence of a variety of environmental factors such as temperature, humidity and light.

Instruments

We are constantly investing in our capabilities and modernizing our equipment and facilities. Our laboratories are fully equipped with a mix of modern state-of-the-art instrumentation, and internally designed, innovative equipment.