Tissue establishment licensing services including responsible person activities and market approvals, market access and key quality processes in both EU and US
Services in the area of quality and regulatory affairs covering human tissues to import/ export, obtain approval and market the medical products in all countries.
Regulatory Strategy and Due Diligence
- Fast track opportunities to import products into the EU and market in different countries
- Strategic regulatory road map to obtain product licenses in various countries
- Strategic road map combining regulatory and commercial aspects to facilitate new funding
- Gap assessments RA/ QA/ QC
QA/ QC/ Licensing
- Market Access and Market approval including registrations of human tissues: prepare human tissue dossiers, ensure compliance to local regulations, manage registrations / notificationsleading to market approval.
- Tissue establishment license approval
- Tissue licenses
- Manage inspections by human tissue Competent Authorities
- QMS for tissue establishments / audits
- Stem cell banking quality management systems and licenses
- Responsible person services
- Batch release, review donor files to allow import of tissues allografts into the EU
QA/ QC / GMP Development
- Set-up or improvement compliant quality management systems
- Risk Management
- Validation Processes, Methods
- (Interim) Quality Management or quality support.
- Multiple regulatory and logistical strategies for human tissues (bone, (including DBM), skin, nerve, amnion) including market approval/ registration or notification trajectories in Europe, US, South America, Middle East, Australia e.g.
- Tissue establishment licenses trajectories and approvals in various EU and non-EU countries