Ensure full EU and global regulatory compliance for your medical products with expert guidance.
Overview
Pharmaceutical manufacturing facilities and contract manufacturing organizations (CMOs) place high priority on occupational safety and product safety. The challenge for manufacturers is to ensure safety is protected and aligned with Health Authority (HA) GMP guidelines.
By performing cross-contamination assessments (VICH GL 18, ICH Q3C), Permitted Daily Exposure (PDE) calculations, Accepted Daily Exposure (ADE) calculations, residual solvent analysis in ppm, LD50 determination, and occupational exposure assessments such as OELs and OEBs, Maven assists organizations in achieving end-to-end compliance.
Expertise
Product Safety
- Expertise in EMA GMP guidelines for health-based exposure limits
- Calculation of NOAEL, NOEL, and LOAEL
- PDE calculations for APIs and other exposure limits
- Region-specific regulatory support
- Derivation of ADE, TTC, LD50, residual solvents and impurities in ppm
- Cleaning validation monitoring across multiple products
- Access to toxicological literature and databases
- Support for ICH Q3C and ICH Q3D compliance
- Streamlined data collection and PDE reporting
Occupational Safety
- OEL calculation to ensure worker safety
- Establishment of occupational exposure bands (OEBs)
Advantages
- Highly qualified toxicologists and data scientists with deep expertise in risk assessment
- First-hand GLP experience and GMP process knowledge
- Robust QC and regulatory writing for audit-ready documents
- Faster delivery times compared to industry norms