Finished Product Manufacturing
We offer a complete package to ensure effective project management — from API sourcing and technology transfer to variation filing — or just the modular services you require.
Finished Product Contract Manufacturing Service Modules
Identification and Qualification of Suitable Contract Manufacturer
For over twenty years, we have developed a worldwide network of pharmaceutical contract manufacturers, which enables us to offer almost every type of contract manufacturing project, regardless of the dosage form and active ingredient. We combine first-rate sourcing expertise with excellent regulatory and GMP know-how to identify the contract manufacturer that best matches your requirements.
Site transfers — which are the most laborious part within every manufacturing project — will be supervised by dedicated technical project managers with many years of experience. This ensures a smooth transfer of all aspects — including project management, quality and regulatory services — on the way to routine production. Time and cost optimization are key issues within our project realization. So we are in continuous contact with contract manufacturers to ensure they stay within the defined limits of budget, critical path and timelines.
Customizations of Equipment, Dossier and Product Characteristics
If your product is considered to be no longer competitive in the market, due to product costs, quality or regulatory reasons, we will tailor solutions by paying attention to your special requirements. Sometimes a technology transfer alone is not sufficient to solve the problems; whereas in other situations a site transfer is not even needed. For example, we can also find solutions to match your needs with regard to:
- Changes of API or excipient source
- Optimization of formulation
- Optimization of manufacturing process using customized equipment
- Optimization of product characteristics.
If required, we can offer to switch to an alternative dossier. Even if you would like to extend your product portfolio with a new dosage form during life cycle management or to overcome an obstacle which up to now prevents a smooth product transfer, we will find a solution.
For all these services you will get a dedicated and experienced project manager.
In addition to finished product manufacturing, we offer a range of complementary services to meet your needs and challenges.
Finished Product Development Services — can provide reformulations and partial developments, e.g. due to change of equipment. More
Quality Management Services — qualify API and FDF production sites. More
Regulatory Affairs Services — offer national, MRP, DCP, CP filing and variations. More