The life cycle of a medicinal product never ends: new regulatory and legal requirements have to be met, technical and technological changes need to be undertaken, and documentation needs to be amended to the latest state of knowledge. You need to keep track of deadlines and communicate and implement changes with partners and the authorities.
We support you with specific aspects or we can take on the entire spectrum of necessary regulatory, analytical and technical activities. Our goal is to ensure that your products are marketed without restriction.
Regular review and update of the marketing-authorisation dossier
Preparation, submission and processing of the relevant change requests for the competent authorities (e.g. variations, change notifications)
Planning and implementation of change-control processes
Evaluation and processing of deviations in, for example, procurement and manufacturing
Monitoring and meeting deadlines
Tasks as part of quality management
Monitoring regulatory compliance in the supply chain
Conducting audits of suppliers and service providers
Preparation and follow-up of inspections by the competent authorities
Dr. Andrea Klüting Vigilance & Regulatory Affairs Business Development HWI group
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