divineGRP team always manages to be one step ahead of future demands by constantly monitoring market developments, focusing on -
Selection of API manufacturer ensuring uninterrupted supply of patent-free drug substance of the highest production standards, following CGMP inspection of the facility and assessment of the quality documentation.
Analytical method development and validation
Design and Monitor of Pre-formulation and formulation trials for all dosage forms at a selected laboratory
Selection of finished product manufacturing site that integrates the effectiveness of the technology transfer, balances geographically the first commercial launches opportunities and accredits the reliability of the commercial supply.
Design and monitor manufacture of validation batches, select approved CRO ,design of Bioequivalence study protocol.
Development Data Collection, Evaluation & Dossier Compilation
For us at divineGRP, all stages of development are equally significant. By valuing every step and challenge, we are able to support our clients from the simplest to the most critical CMC and quality demands throughout the compilation of their pharmaceutical dossier.
divineGRP operations and services within the product development sector are governed from the values of quality, consistency, flexibility, safety and efficiency throughout all stages of the development process.
divineGRP fortifies its support to the strategic partners by adding on intellectual properties, specially developed for specialty products.
divineGRP’s confidence stems from partnering specialised CRO’s and our experts’ extensive exposure to various challenges and numerous accomplishments within the EU and the global pharmaceutical market, enabling us to fully support the following range of services: