Medical Devicesand IVDs
- Regulatory Pre-Market Submission Strategies
- US Pre-market Submissions – PMA, HDE, IDE, EUA, Pre-Sub/Q-Sub, and 510(k)
- Global Pre-Market Submissions – European CE Mark Technical Files/Design Dossiers (MDR and IVDR), Canada Medical Device Licence, Japan, Australia, Latin America, etc.
- CLIA Waiver Applications and Submissions
- Clinical Trial Strategy, Design, and Project Management
- GCP Auditing
- Quality System Design, Development, and Auditing – including ISO 13485, FDA QSR, MDR/IVDR, MDSAP, Health Canada, Australia TGA, and Japan MHLW requirements
- Adverse Event, MDR, and Vigilance Reporting Assistance
- Recall and Field Corrective Action Assistance
- Risk Management Design, Development, and Auditing – including ISO 14971 compliance
- CAPA Design, Development, and Assistance
- Import/Export Compliance Review and Assistance
- Labeling Compliance Review and Assistance
- Establishment Registration and Device Listing Assistance – including FDA and State of CA FDB
- FDA Form 483 and Warning Letter Review and Assistance
- Conduct assessments of client analytical studies, clinical studies, procedures, and programs to determine regulatory gaps and compliance
- On-site training available on all the above listed topics
- FDA, Notified Body, and Competent Authority liaison and negotiator
- Due Diligence Auditing
Pharmaceuticalsand Biologics
- Regulatory Pre-Market Submission Strategies
- Pre-market Submissions – ANDA, OTC Monograph, BLA, IND, and Pre-IND
- Clinical Trial Strategy, Design, and Project Management
- GCP Auditing
- Quality System Design, Development, and Auditing – including ICH and FDA cGMP requirements
- Adverse Event and Pharmacovigilance Reporting Assistance
- Recall Assistance
- Risk Management Design, Development, and Auditing – including ICH Q9 compliance
- CAPA Design, Development, and Assistance
- Import/Export Compliance Review and Assistance
- Labeling Compliance Review and Assistance
- FDA Form 483 and Warning Letter Review and Assistance
- Conduct assessments of client analytical studies, clinical studies, procedures, and programs to determine regulatory gaps and compliance
- On-site training available on all the above listed topics
- FDA and Competent Authority liaison and negotiator
- Due Diligence Auditing
DietarySupplements
- Pre-market Compliance Assessment
- Clinical Trial Strategy, Design, and Project Management
- GCP Auditing
- Quality System Design, Development, and Auditing – including FDA cGMP requirements
- Complaint Handling and Adverse Event Reporting Assistance
- Recall Assistance
- Risk Management Design, Development, and Auditing
- CAPA Design, Development, and Assistance
- Import/Export Compliance Review and Assistance
- Labeling Compliance Review and Assistance
- FDA Form 483 and Warning Letter Review and Assistance
- Conduct assessments of client analytical studies, clinical studies, procedures, and programs to determine regulatory gaps and compliance
- On-site training available on all the above listed topics
- FDA and Competent Authority liaison and negotiator
- Due Diligence Auditing
