Pro Bono:

• A Free Regulatory "Initial Assessment" is offered to Small Start-up Biotech
  companies and to Pre and Post Spin- Outs from Universities.

Services Offered

• Guidance on regulatory and development strategy
• CMC regulatory affairs,
• Product manufacturing and testing,
• Scale up and Process Validation
• Facility inspections, and program management
• Change Control Corrective Actions
• Deviations Management
• Non Conformance Management
• FDA Compliance
• Out of Specifications (OOS) management
• Review and assembly of IND’s, BLA’s and CTD’s
• Development of timelines, budgets, and personnel requirements for “tech transfer”
• Mock Audits
• Preparation for FDA meetings
• Advisory Meetings
• Due Diligence Review of Regulatory Files

Validation/qualification of:

• Overall Validation Programme assessment
• Manufacturing Process
• Facilities
• Equipment

Compliance:

• FDA dispute resolution process
• Surveillance Inspection reports

Audits/Inspections:

• Mock FDA inspections (GMP&GLP)
• Quality Systems Review
• Due diligence audits and assessments
• Mock Pre-Approval Inspections

Quality Assurance:

• Document System development and review
• Quality System evaluation/development

Manufacturing/Quality Control:

• Development/review of CMC section of regulatory submissions
• Process Development/technology transfer
• Management manufacturing operations

Professional Translation from Japanese to English & English to Japanese
huw@innestranslation.com