We are confident that you will enjoy working with our passionate team of experts. Through our open approach and teamwork, we believe we are your partner of choice that you can rely on to develop new ideas to generate greater opportunities for your business.
We have the expertise, flexibility and the resources to provide a full range of pharmaceutical custom development services. Ranging from investigational new drug (IND) support from pre-clinical to Phase III clinical trials and technology transfer for commercial supply, our development experts can support your products at every stage of the product lifecycle.
Our custom development capabilities include:
- Route scouting
- Process development, optimization and scale-up (early to late stage, small to large scale)
- Risk management
- Clinical batch supply
- cGMP (FDA) and non-GMP routine production
- Development, optimization and validation of analytical methods
- Synthesis and purification of analytical reference standards and impurities
- Quality by Design (QBD)
- ICH stability studies
- Safety and toxicology assessments
- Regulatory support
- Supply chain