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 MOREPartner with DDReg for end-to-end New Product Marketing Authorization Services
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 New Product Marketing Authorization Services?
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
We offer end-to-end regulatory solutions to simplify the approval process for pharmaceutical companies:
- Regulatory Documentation Review – Ensuring accuracy and compliance in product dossiers and technical documents.
- Gap Analysis & Remediation – Identifying and addressing regulatory gaps to meet global submission requirements.
- CTD Authoring – Crafting CMC sections, non-clinical and clinical overviews, and summaries for submissions.
- Biowaiver Justifications – Supporting cost-effective approval strategies with scientifically backed justifications.
- Global Submission Support – Managing MRP/DCP/CP/RUP procedures in the EU, WHO PQ, EAEU Procedure, Zazibona procedures and other international markets.
- Regulatory Content Development – SmPC, PIL, PI Preclinical/Clinical authoring, and comprehensive dossier compilation.
- Artwork & Labeling Reviews – Ensuring compliance with country-specific packaging and labeling guidelines.
- Agency Query Responses – Crafting strategic responses to regulatory inquiries to prevent delays.
With over a decade of expertise, DDReg helps pharmaceutical companies navigate the ever-evolving regulatory landscape with precision and efficiency.