We provide consulting services in the field of solid state research, crystallization, particle technology and pharmaceutical development:
- Data review and strategic guidance
- Preparation of Request for Proposals
- Selecting suitable CRO/CDMO and overseeing projects, e.g.
- polymorph, salt, cocrystal, and amorphous dispersion screening
- preformulation and formulation development
- physicochemical testing of drug substance and drug products
- solid state and particle size method development and validation
- experimental design for crystallization process development for purification, polymorph and/or particle size control
- de-risking and troubleshooting of drug substance and drug product processes
- scientific review of project updates and reports
- Defining API needs and supporting drug product development activities
- Analytical support for solid state, particle & PAT techniques
- Preparation of summary reports or presentations
- Regulatory guidance associated with solid forms and particle characteristics
- Technical writing for relevant sections of IND and NDA
- Strategic guidance for intellectual property protection
- Scientific review of patents