Active Pharmaceutical Ingredient (API)
- Technical review and critique of the synthetic route from gram to Kilo lab to commercial scale.
- Support in defining the development plan for API, including assessment of other possible routes and cost of goods.
- Critique and selection of appropriate CRO (s) for development and manufacture of clinical, development and commercial materials.
- Provision of technical oversight of the selected CRO.
- Direct support for readiness and real time support for Pre Approval Inspections.
- Problems solving.
Analytical Development
- Scientific and technical support to API and Dosage Form analytical method development, testing and appropriate stability programmes.
- Critique and selection of appropriate CRO(s) for analytical method development, analytical testing (including GMP) and stability programmes.
- We have our own designated Analytical Laboratory.
Formulation, Drug Delivery & Development
- Technical support in development of appropriate dosage forms covering early enabling formulations through to a final commercial product.
- Scientific support in developing the most appropriate dosage form based upon the physico-chemical properties of the API.
- Expertise in all types of formulations e.g. tablets, capsules (including controlled & modified release, soft gelatin capsules), semi-solids, parenterals, nano technology, transdermals, biotechnology products.
- Critique and selection of appropriate CRO(s) for development of the dosage form.
- Provision of technical oversight of the selected CRO.
- Design of the appropriate DoE and QBD/PAT strategy.
- Direct support in trouble shooting and resolution of technical problems.
- Primary and secondary packaging development.
Clinical Trial Supply & Commercial Manufacturing
- Selection of appropriate GMP compliant CRO(s) for API and Dosage Form manufacture and testing of supplies (including packaging, labelling, blinding, assembly and distribution) for clinical trials and also commercial supply.
- Problem solving.
- Direct support for readiness and real time support for Pre-Approval Inspections.
Regulatory CMC Documentation & Filings
- Development of regulatory filing strategy for key global markets.
- Scientific and technical support for regulatory submissions (IND's, NDA) including support in drafting CTD documents and interacting with the agencies (FDA/EMA) including answering queries.
Technical Training Courses
- Selection from a library of available courses e.g. GMP compliance/CAPA, Lyophilisation Development, Semi-Solid Formulation Development, Tablet and Capsule Development, Technology Transfer, SUPAC and API change control.
- Development of customised training courses.
- Site implementation of training courses on a large or small group basis.
- Utilisation of experience to provide highly interactive presentations and use of case studies.