Our experts can help you comply with local, regional and global health regulatory requirements to ensure Market Access in Europe, Middle East and Africa regions: Our expertise is to ensure that new products reach new markets meeting legislation and competent authorities’ requirements on pre and post marketing basis.
We can help you on Regulatory Affairs, Vigilance and Business Development based on ensuring the Quality and Safety of products, processes and systems.
We can provide individual services or full-service combining all mandatory safety and compliance aspects beginning from the development, safety assessment, label and claim, review, dossier building and notifications / registrations.
We cover a large portfolio of products: Food Supplements, Cosmetics, Medical Devices, Drugs.
Services can include:
• Developing new formulas and/or products
• Identification of applicable requirements according to the product classification, including regulatory requirements, market and customer drivers, etc.
• Preparing regulatory strategy and submissions
• Compiling and redaction of regulatory files and application forms.
• Creating a comprehensive Product Information File (PIF) to satisfy all EU and other states requirements
• Ensuring compliance, label and claim review
• Vigilance support (redaction and submission)
• Responsible person services
• Brand registration and protection
• Market Access : Ensure global health compliance and registration
• Third-party technical liaison: subcontractor, distributor, etc.