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.
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 and validate new analytical methods and to import and modify existing methods.
Our regulatory departments have substantial experience in supporting global submissions of our partners' sterile pharmaceuticals. CMC parts of the files are drafted in the CTD standard, guidance is offered based on knowledge of the relevant regulatory regimes worldwide, and interaction with the regulatory bodies side by side with you, our partner, is our day-to-day business.
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.
All our manufacturing sites have conditioned warehousing spaces. Storage of all materials 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
We are experienced in sourcing all the materials needed for manufacturing your sterile pharmaceuticals according to your product specifications from suppliers that we have audited and qualified in our vendor programs.
Life Cycle Management
As a full-service provider we support our partners throughout all stages of the product life cycle. We contribute at clinical trial levels, secure supply during growth of a product, and offer additional services during the later stages of the life cycle.