Cost-effective manufacturing support that optimizes outcomes during the development of new drug products.
How a drug is delivered can impact the result of the first clinical evaluation stage of a new drug product. For first-in-human (FIH) studies this might be a liquid, gel, cream, capsule, tablet or powder in a bottle ready for reconstitution.
Our solution
We offer a comprehensive range of services to help you ensure your drug product uses the right delivery approach.
Whether you decide upon tablet, capsule, liquid, gel or cream, our experts will support you using all early stage manufacturing technologies, including micro dosing systems. We cover both liquid and solid dosage forms, including cytotoxic and potent, and can support you with the manufacturing of controlled drug products.
Good manufacturing practices (GMP) allow us to manage even the most complex formulations, working in line with strict regulatory requirements and to the highest quality assurance standards.
Additionally, our experts can provide analytical characterization, preformulation and formulation data services to support you during clinical trial and investigational medicinal product dossier (IMPD) submissions.
Scaling-up
With advanced facilities and in-house analytics, we provide a framework to enable effortless scaling-up of products for clinical manufacturing beyond phase I.
We will support you through the clinical evaluation process, from practical advice on the preparation of technical transfer packages to the licensing out of products or transfer to commercial contract manufacturers.
Benefits
- Cost-effective solutions
- Global network of experts
- Access to the latest technologies
- State-of-the-art testing facilities
We are recognized as the benchmark for quality and integrity. Wherever you operate in the world, we support you at every step of your product’s development – from raw materials to end product – helping you develop the right delivery system for your drug product.