Services provided
Design Phase Support: Early-stage regulatory advice and technical direction to help ensure products are developed with approval requirements in mind.
Approval Route Assessment: Identifying the most appropriate approval route based on intended production volumes, target markets and regulatory requirements.
Technical Documentation: Preparation, review and management of technical documentation required to support approval applications.
Testing Planning & Management: Identifying applicable testing requirements, coordinating test programmes and managing the approval process.
Authority & Test Service Liaison: Liaising with technical service providers, test laboratories and regulatory authorities throughout the approval process.
Conformity of Production (CoP): Support with CoP requirements, quality systems, audit preparation, audits and ongoing production compliance.
Training & Technical Support: Providing training, guidance and ongoing support to help develop internal knowledge and competence.