In applications for Generic and Generic Plus medicinal products, the concept of bioequivalence is fundamental.
The purpose of establishing bioequivalence is to demonstrate equivalence in biopharmaceutics quality between the generic medicinal product and a reference medicinal product in order to allow bridging of preclinical tests and of clinical trials associated with the reference medicinal product.
Lamda’s role is to help our partners navigate through the complex landscape of clinical development by proposing the optimal clinical development plan for success. We provide support in designing clinical studies and we handle the project management throughout this phase. In addition, we manage projects in which clinical studies can be waived or cases where more complex data or studies are needed. In the latter case, we also provide assistance in the preparation of and participation in scientific advice meetings with the Authorities.
Lamda cooperates with a group of experienced professionals and well trusted Clinical Research Organisations (CROs) to execute the Clinical Development Plan successfully.
We devise and implement product specific development strategies capable of delivering high-quality formulations and robust manufacturing processes.
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.
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.