We specialize in guiding BioPharmaceutical and Biotechnology industries through the complex landscape of regulatory affairs, with a specific focus on Chemistry, Manufacturing, and Control (CMC) for biological products.
At MP BioReg Consulting, we specialize in guiding BioPharmaceutical and Biotechnology industries through the complex landscape of regulatory affairs, with a specific focus on Chemistry, Manufacturing, and Control (CMC) for biological products. Our mission is to help companies meet and exceed their CMC challenges, ensuring compliance and optimizing processes from development to market approval. "Navigating scientific and regulatory challenges in CMC? MP BioReg Consulting offers expert solutions to guide you through."
Regulatory strategy optimization
Scientific and CMC regulatory advice to optimize strategies throughout product lifecycle stages.
CMC dossier authoring
Authoring and review of comprehensive CMC dossiers, from clinical trials to new marketing applications and post-approval variations, as well as authorities briefing documents
Interim management support
Management support, including interim management and collaboration with technical teams, focusing on issue and risk management
Regulatory compliance training
Training and coaching for staff and managers to enhance regulatory compliance and efficiency.
Biological product strategy
Advisory consultation to pharma and biotech companies on various aspects of strategic pathways for biological products.
We are highly adaptable in our service delivery, offering on-site, remote, or hybrid solutions tailored to best suit the needs of each mission.
