Kinapse Outsourcing

Kinapse Outsourcing provides cost-effective writing and analytical services for business critical information and documents for reporting and submissions.

Our outsourcing services span:

Medical writing:

• Clinical / regulatory (e.g. clinical study reports, safety narratives, investigator brochures, etc.)
• Clinical trial disclosure documents (protocol and results summaries)
• Scientific communications (eg manuscripts, posters, abstracts, etc)
• Quality checking (of clinical and regulatory documents)
• Reference checking (of scientific communication documents)

Regulatory affairs, CMC and publishing:

• Regulatory documentation writing and submissions written in common technical document (CTD) format (including Module 4 and 5)
• Chemistry, manufacturing and controls (CMC) documentation writing and submissions

Pharmacovigilance:

• ICSR processing and reporting services
• Pharmacovigilance organisation design
• Process improvement
• Capability building and inspection readiness
• Productivity consulting
• PV auditing