Being compliant with stringent global regulatory requirements is becoming a challenging issue for product registrations and drug approvals. DDReg can partner to help you define Regulatory strategies right from the product development to lifecycle management to addressing all submission requirements, and to comply with the mandatory requirements.
Regulatory Strategies for global filing of products;
Strategies for moving products approved in one region to another market (e.g USA to Europe or vice versa)
Stability study planning for all possible presentations / container closure system
Identification of reference medicinal product as per the global commercialization plan and defining the Regulatory route map.
DDReg is a global pharmaceutical consulting firm that deals with regulatory services for leading pharmaceutical companies. We are trusted partner of leading pharmaceutical companies to manage their regulatory affairs portfolio.