Every certification, declaration, and test report backing Bioneau’s biopharma product range — organized by category, mapped to product lines, and available on request for audits and regulatory submissions.
Certifications & declarations
Compliance categories
Certified quality system
Product platforms covered
Filings with FDA and equivalent bodies covering material contact and drug master file status.
Biological safety testing across cytotoxicity, sensitization, and systemic response.
Compendial testing against European and US Pharmacopeia benchmarks.
Declarations confirming material origin, contact safety, and freedom from restricted substances.
Compliance with EU restricted-substance and chemical-safety directives.
Long-term stability and extractable/leachable profiling per ICH guidance.
Certification of the facility-wide quality management system.
Tell us which categories and product line you need, and our Quality Assurance team will send the full document set — no need to chase down items one by one.
For enquiries contact us at monika@bioneau.com
