- Adaptive Trials
- Translational
- Clinical
- Regulatory
- Pharmaceutical
- Medical Device
- FDA Pre IDE Support
- FDA Submissions
- 510 (K) Submission
- Investigational Device Exemption Applications (IDEs)
- Premarket Approval Applications (PMAs)
- Investigational New Drug Applications (INDs)
- 513(g) Requests for Classification
- FDA Registration / U.S. Agent
- Canadian License Applications
- EU Directives / CE Mark
- FDA Quality System Regulations (QSR)
- ISO 13485 Compliance
- ISO 14971 Risk Management
- Quality Assurance Audits
- Ongoing Postmarket Compliance
- Trio Resourcing
- Therapeutic Expertise
- Medical Devices
- Japan
Global Reach
Aptiv Solutions has extensive pre-clinical, non-clinical and clinical operations powered by a team of more than 850 professionals working in North America, Europe, the Middle East and Japan.
International CRO
Adaptive Trial Design
Aptiv Solutions is the only CRO to offer design, simulation and execution
of adaptive clinical trials – and the only partner to make fully functional
adaptive clinical trials a reality.
Adaptive Clinical Trials
Medical Devices
We have helped our clients achieve over 600 510(k) clearances,
50 PMA approvals, and prepared dozens of technical files and
design dossiers to obtain the CE Mark.
Medical Device Services
Flexible, Customized Solutions
Aptiv Solutions offers comprehensive and innovative drug development
services – so our clients can adapt effectively and efficiently to rapidly
changing conditions.
Drug Development Services
Therapeutic Expertise
Aptiv Solutions has a broad range of therapeutic experience – and
particularly deep expertise in Oncology, Cardiovascular Disease,
Dermatology, Respiratory and Orphan diseases.
Clinical Trial Expertise
