I offer flexible consulting and support services in pharmaceutical regulatory affairs, tailored to your company’s individual needs.
My services include:
- Regulatory Affairs Consulting: Support with regulatory strategies, requirements and procedures throughout the product lifecycle.
- Marketing Authorisation Applications: Assistance with the preparation, compilation and maintenance of marketing authorisation dossiers.
- Variations and Lifecycle Management: Support with variation classification, submission planning and post-authorisation regulatory activities.
- Product Information: Preparation, review and maintenance of Summary of Product Characteristics (SmPCs), package leaflets and labelling.
- Electronic Product Information (ePI): Support with the evolving requirements and implementation of electronic product information.
- Regulatory Tools and Resources: Practical tools to support variation classification, fee calculations, workload estimates and the assessment of regulatory protection periods.
I offer project-based consulting as well as ongoing support, either as a freelance consultant or through an employment arrangement.
My aim is to provide clear, reliable and practical regulatory support that helps you manage your projects efficiently and meet regulatory requirements with confidence.
Please feel free to contact me to discuss your requirements.