Finished Product Development
The development of technically and commercially suitable galenical formulations plays a vital role in managing the lifecycle of innovative and generic finished drug products. We provide a complete range of services for developing and manufacturing finished drug products, and we have expertise and experience to overcome challenging galenical or analytical hurdles.
Full Drug Product Development
With an extensive global network of external development and manufacturing partners, we are able to draw on many pharmaceutical technologies that can be applied to produce a multitude of finished drug products.
Some of the technologies available for the development of finished drug products include:
Modular Development Support
We offer expertise in overcoming difficulties with your own developments. Our experienced team of finished product development experts is ready to apply their know-how to support you 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
We design customized development strategies and evaluate the potential for process optimization. Our technical and commercial expertise enable us to create effective strategies 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 global network of established development partners, we are able to find the right one for your project. We analyze all important factors — such as technical capabilities, competitiveness, logistics and IP — to select a development partner that meets your requirements.
We provide leadership in project management, including compiling, implementing and monitoring project plans and development activities. From our experience, we understand the complexities that can 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
Our practical skills and experience in analytical and formulation development enables us to ensure that processes are properly described, implemented and followed. We develop, implement and assess suitable instructions for analytical methods and galenical processes. This includes matching analytical requirements with formulation development and vice versa.
Onsite Supervision of Critical Development Activities
We recognize the importance of onsite supervision of finished product development. Managing a project over the phone or having your staff onsite is not always possible. We provide onsite supervision of critical development steps. This makes it possible to respond quickly to unexpected events.
We understand the many and complex steps required to bring finished drug products from development to commercialization. By recognizing the importance of cross-functional interaction between all disciplines — including API, commercial, technical, regulatory, patent, quality and supply chain — we make sure all the pieces fit together. Our experience also enables us also to cope with unexpected twists along the way.
The specialist teams at Midas cover all stages of the pharmaceutical value chain and are able to provide complete solutions to meet the specific needs of each customer.
As well as finished drug product development, we offer a range of 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. More
Quality Management Services — qualify API and FDF production sites including audit reports. More
Regulatory Services — offer national, MRP, DCP, CP filing, variations, and communication with regulatory authorities. More
Intellectual Property Services — patent landscape evaluation, generation and protection of novel IP, support in case of patent application. More
Business Development Services — internationalize your development. More
If you intend to develop finished drug products, Midas is the one-stop-shop to provide you with all-round carefree solutions tailor-made to your needs.Please contact: