New Product Marketing Authorizations
Pursuing a submission package is a complex and time-sensitive process. Every country has its own regulatory framework, making it challenging for pharmaceutical companies to ensure they fulfill all requirements for a successful submission.
DISCOVER MOREEnd-to-End Support for New Product Marketing Authorization
DDReg specializes in marketing authorization for pharmaceutical & biotechnology products, helping companies streamline regulatory approvals and accelerate market entry. Our team of experts has successfully filed new product marketing authorization applications in over 120 countries, ensuring compliance with ICH, WHO, and regional authorities.
Why Choose DDReg for Gap Analysis & Remediation?
DDReg is a trusted partner for the global pharmaceutical and biotechnology industry seeking faster market entry through timely grant of Marketing Authorization for pharmaceutical or biologics products. With over a decade of expertise, we have successfully managed marketing authorization and global regulatory approvals across 120+ countries. Our team of experts understands the complexities of the regulatory process and provides tailored solutions to streamline the process. From pre-submission reviews, gap analysis & remediation to dossier compilation and agency query responses, we ensure a seamless pathway to approval. With our in-depth regulatory knowledge and commitment to quality, DDReg helps you accelerate market entry while maintaining full compliance with ICH, WHO, and regional health authorities.
Our New Product Marketing Authorizations Expertise
With over a decade of expertise, DDReg helps pharmaceutical companies navigate the ever-evolving regulatory landscape with precision and efficiency.