Our contract research services are aligned to help our customers identify the optimal dosage form and reduce costs during the development of their products.
Over the last 26 years we have worked with a variety of large and small companies and learnt a few things about service provision.
Our Contract Research and Contract Manufacturing services are integrated in order to provide our Customers with a “one-stop-shop” for all their formulation, clinical development and product supply needs. From pre-clinical discover to product life-cycle management we work closely with our Customers in order to minimise costs and development timelines.
Our Contract Research services include:
- API characterisation that is useful in understanding the physico-chemical properties of new molecules and predicting any challenges in the design of a viable formulation.
- Our proprietary ExcipBaseTM database contains API-excipient compatibility information that we have collected from various formulation screens (positive and negative data) we have undertake over the years and is complemented by published research data.
- Our high-throughput ExcipScreenTM service provides a quick and inexpensive route to a compatible formulation for your drug substance. ExcipScreenTM has been designed with liquid-fill formulation in mind since we can undertake excipient screening at elevated temperatures (up to 75 deg.C) that provides the same temperature range as used in development and commercial scale liquid filling equipment.
- The design of scaleable formulations for poorly soluble drugs and those with unusual physico-chemical properties (e.g. hygroscopic, deliquescent or air/oxygen sensitive products).
Clinical Trial Supply
We offer the supply of clinical trial finished drug product throughout the development process and can package and ship product globally.
- Finished drug product supply and packaging throughout the clinical trials process (Phases I through to IV), complaint with EU Clinical Trials Directive, including QP release.
- Life-Cycle management solutions including the redesign of older formulation to improve drug release and bioavailability or re-targeting. This can sometimes lead to the creation of new intellectual property and facilitate life-cycle extension strategies for near-patent expired products.
- These services are supported by state-of-the-art analytical testing, QA and QC departments.
Our fully GMP compliant development and manufacturing facility is based in Ziefen, near Basel, Switzerland and is routinely inspected by Swissmedic and regularly audited by our customers.
Our contract research services covers the following area
- Formulation design & optimisation including API characterisation
- Fast-into-man prototype development
- Formulation design and process development
- European Phase I-IV clinical trial supplie
- Process scale-up, validation & technology transfer (if required to Customer or 3rd party facility)
- Product characterisation
- Stability testing to ICH standard
- International registration support
For more information on how we can be of help, please contact us now.