SUPPORT SERVICES
Based on our aim to be a full-service provider to our partners, we have built a large portfolio of supporting activities that facilitate the development of formulations and processes and manufacturing of products in an efficient and cost-effective manner.
Laboratories
We provide full QC support - physical, chemical, and microbiological - for starting materials, finished products, and in-process control. In-house expertise is available to develop new analytical methods and to import and modify existing methods.
As new products become viable candidates for clinical trials, full validation of the analytical procedures is performed.
Regulatory
Our regulatory departments have substantial experience in supporting global submissions of our partners' products. In collaboration with the development department, the CMC parts of the files are drafted efficiently in the CTD standard to assure the quickest route to the market.
During contract development of research products, the regulatory staff interacts with the project team offering guidance and recommendations based on knowledge of the relevant regulatory regime, including FDA requirements. For commercial manufacturing, regulatory assistance is available to support submissions worldwide, including INDs and NDAs.
During the review process, our regulatory staff and development and manufacturing experts interact with the regulatory bodies side by side with you, our partner.
Stability Studies
Each of our plants has qualified in-house climate chambers and can do ICH-compliant stability studies, using carefully set conditions depending on product characteristics, regulatory requirements and the desired shelf life.
Logistics
All our manufacturing sites have conditioned warehousing spaces. Storage of active ingredients, excipients, packaging materials, intermediates and final product is possible at ambient temperature (15°C-25°C) and at 2°C-8°C.
Worldwide shipping and distribution services are available on demand and are used by a number of partners.
Procurement of Materials
Our purchasing staff is experienced in sourcing all the materials needed to manufacture our partners' products. We generally take care of sourcing all excipients and packaging materials according to your product specifications from suppliers that we have audited and qualified in our vendor programs. Increasingly, our existing partners also rely on us to purchase the active ingredient. Of course, we can also handle materials purchased by our partners as customer-owned inventory.
Life Cycle Management
Being a full-service provider also means that we support our partners throughout all stages of the product life cycle. This means being able to contribute at clinical trial level, to secure supply during (strong) growth of a product, to manufacture a product at full size, and being able to offer additional services during the later stages of the life cycle. We offer sourcing risk management in the form of setting up manufacturing processes at multiple sites, and we draw up business continuity plans together with our partners.