We offer effective FDA regulatory support for all sizes of firms – from start-up to large corporations. Our FDA consulting services are fully tailored to address your particular business needs. We coordinate efforts to deliver your services on time and within budget. We maintain constant accessibility and support both on- and off-site during the course of your FDA consulting project.
WE CAN HELP YOU WITH:
- Product development
- Lifecycle management
- Manufacturing and clinical strategies.
- Product and Facility Registrations
- Labeling Registrations
- INDs, BLAs or NDAs
- Quality System Regulations
- GCP system Development
- GMP, GCP and GLP Audits
- Regulatory data and filing Audits
- GAP Analysis
- Inspection and Warning Letter Responses
- Consent Decree
- Recall Management and GMP.
– Quality/Clinical/Regulatory Assessment Audits