Modular Formulation Development

To overcome difficulties with in-house research and development, companies are turning to specialized and experienced finished product development experts for their know-how to support in all drug development phases, including:
 Establishing product target profiles
 Developing suitable analytical methods and galenical formulations
 Scaling up
 Validating methods and processes
 Conducting stability studies
Customizing Drug Product Development Strategies
Effective strategies can be designed and potential for process optimization can be evaluated by technical and commercial expertise, including:
 Commercial, patent and regulatory aspects to increase the viability of development projects
 Taking a developed lab formulation through the stages to reach commercial success
 Developing suitable quality-by-design and suitable commercial scale manufacturing requirements already during early development.
Selecting Suitable Development Partners
With a network of established development partners, a right match can be found for the concerned project. All important factors, such as technical capabilities, competitiveness, logistics and IP, can be analyzed to select a development partner that meets requirements.
Project Management
Project management, including compiling, implementing and monitoring project plans and development activities, can be done by understanding complexities that arise when collaborating with cross-functional development teams. This enables us to accurately plan and realize relevant tasks.
Assessing, Improving and Implementing Manufacturing Processes and Analytical Methods
Practical skills and experience in analytical and formulation development enables to ensure that processes are properly described, implemented and followed. Matching analytical requirements with formulation development helps to develop, implement and assess suitable instructions for analytical methods and galenical processes.
Onsite Supervision of Critical Development Activities
When it is not feasible to manage a project over phone or have an onsite staff, the supervision of critical development steps can be handled by experts, making it possible to respond quickly to unexpected events.
Finished Drug Product Marketing
The varied complex steps required to bring finished drug products from development to commercialization can be done by experienced solution providers. By recognizing the importance of cross-functional interaction between all disciplines – including API, commercial, technical, regulatory, patent, quality and supply chain – and by coping with unexpected twists along the way, the entire process can be held together covering all stages of the pharmaceutical value chain. Complete solutions can be provided to meet the specific needs of each project.
Complementary Services.
Custom Synthesis Services: support API issues and potential custom tailored solutions. More
Finished Product Manufacturing Services: identify contract manufacturers, organize commercial scale manufacturing and delivery of finished products.
Quality Management Services: qualify API and FDF production sites including audit reports.
Regulatory Services: offer national, MRP, DCP, CP filing, variations, and communication with regulatory authorities.
Intellectual Property Services: patent landscape evaluation, generation and protection of novel IP, support in case of patent application.
Business Development Services: internationalize product development.