Securing market access and ensuring reliable product availability
Regulatory expertise and supply continuity across international markets
At Provepharm, regulatory expertise and supply chain security are strategic pillars in ensuring sustainable and reliable access of our medical dyes to international markets.
Our integrated organization is built on strong central expertise, long-term industrial partnerships, and a consistent commitment to quality at every stage of the product life cycle.
Key figures
74
SKUs managed
12
Post-Marketing Requirements (PMRs) & Clinical Studies
38
marketing authorizations (active) and 3 CE markings
A centralized governance model at the core of execution to ensure an optimized regulatory pathway
Our global headquarters leads the key functions required to ensure consistent and controlled execution at an international level:
- Close coordination across Regulatory Affairs, Clinical Operations, CMC manufacturing, and Commercial teams
- Deep in-house expertise in Chemistry, Manufacturing and Controls (CMC)
- Precise and controlled adjustment of manufacturing processes to support regulatory submissions and global supply
Optimized regulatory pathways, integrated from early development stages
Our Regulatory teams are engaged from the earliest phases of development and throughout the entire product lifecycle, from proof of concept to market launch.
Their scope of involvement includes:
- Demonstrating proof of concept during preclinical phases
- Designing clinical study protocols to evaluate product efficacy and safety
- Generating robust clinical evidence of efficacy and safety in patients to support registration and post-approval commitments
- Expertise in pharmacopoeial development, in collaboration with the USP (US) and the EDQM (EU) for the preparation and establishment of monographs.
A model designed to secure long-term market access
- Strong in-house API process expertise enabling strong technical leadership and effective oversight of CMOs
- Strategic, long-term partnerships with best-in-class GMP CMOs and API supplier, with patented APIs manufacturing process for supply reliability
- Dual/multiple-sourcing strategy securing scalable, resilient supply
- End-to-end secure, traceable supply chain meeting the hightest pharma standards
Supporting healthcare professionals
to address their needs and support the evolution of clinical practices
Our product portfolio
A unique portfolio of high-quality drugs and medical devices with multiple uses.