We devise and implement product specific development strategies capable of delivering high-quality formulations and robust manufacturing processes.
To achieve our clients’ goal, several studies are performed as a means of achieving deliverables assigned to certain distinct development phases:
- Preformulation phase: Analysis of bibliographic data, review of existing patents investigation of the most relevant physicochemical properties of the candidate drug substances.
- Formulation development phase: Screening and optimisation studies, varying in nature depending on project’s particular characteristics, provide the necessary level of information for the provision of the optimum composition. Throughout the development phase, contemporary approaches, aligned with the latest ICH recommendations; including the adoption of Quality by Design (QbD)-oriented principles and tools (e.g. statistical experimental design and risk assessment techniques) are implemented for building up the respective development programmes. Development of analytical methods is integral part of this phase.
- Process development phase: Screening and optimization process activities, challenging critical process parameters, give rise to robust and transferable processes. The availability of state-of-the-art equipment, fully representative of and simulating that of industrial scale offers large flexibility in the selection of CMOs, facilitating ultimately the smooth transition from R&D to production scale.
- Scale-up (technology and site transfer activities): Scale-up tasks are effectively undertaken by our skilled team, contributing to the minimizing of tech-transfer risks.
Our state-of-the-art laboratories offer a wide range of analytical services to support your exact needs under strict quality procedures which meet GMP requirements and following ICH guidelines.
In applications for Generic and Generic Plus medicinal products, the concept of bioequivalence is fundamental.
Continuous evolution in science and changes in the regulatory environment and health sector, creates the need for professional regulatory guidance throughout the lifecycle of a healthcare product.