3D Pharma Consulting provides in-depth and holistic formulation and CMC development support for new product development, re-formulation and lifecycle management to enable new product opportunities.
Tailoring to your requirements, we can support the entire formulation development programme or parts, from the initial assessment through pre-formulation to product development, manufacturing, non-clinical and clinical testing. We provide up-to-date knowledge and expertise of established and emerging drug delivery technologies, formulation approaches, quality requirements and regulatory considerations. Throughout formulation and product development, we can assist with the compilation regulatory CMC documentation. Our formulation and product development services include:
- Formulation strategy and design
- Manufacturing process assessment, design, development and technology transfer
- Sterilisation route assessment, testing and validation
- Preparation of regulatory CMC packages
- Selection and management of CROs and CDMOs
- Development of analytical methods for product characterisation, stability programmes and drug-device compatibility testing
- Requesting, executing and interpreting Scientific Advice from regulatory agencies