Services
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.
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.
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.
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.
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.
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.
Utilizations of experience to provide highly interactive presentations and use of case studies.
