We help organisations to manufacture new medicines quickly. We help them to gain rapid regulatory approval for clinical studies. This involves some or all of the following activities:
Audit, selection and management of Contract Manufacturing Organisations and Contract Research Organisations
Management of technology transfer
Writing of Investigational Medicinal Product Dossiers (IMPD)
Qualified Person services
GMP audits and improvement programmes
Training in GMP, quality systems and risk management
Evaluation of facility designs
Investigations into manufacturing and quality control non-conformances and implementation of corrective and preventive action