Combination Products - Voisin Consulting

Identification and justification of the most appropriate regulatory status - product qualification and classification
Preparation of science-based rationale for product development plan
Product-related risk management
Gap analysis for data requirements
Facilitation of interactions between client, Notified Bodies and Competent Authorities - Accompanying clients throughout their product development
Liaison with regulatory Authorities to ensure optimum pathway
Preparation and submission of device and drug sections of regulatory application(s) following regulatory requirements
Advice on GMPs relevant to drug and device