Remediation & Regulatory Agency Response
The TCG team has a proven track record of helping companies navigate regulatory enforcement actions with successful outcomes. Where support is time-sensitive in response to an FDA-483, warning letter, or other enforcement action—we can rapidly mobilize a team of experts.
Services
Our approach is a holistic response to enforcement actions, ensuring that your response and CAPAs are comprehensive. We routinely respond to FDA/EMA/MHRA and other regulatory agencies.
We are an agency-recognized 3rd-party GMP and Data Integrity expert.
Enforcement Action Support
TCG has been retained to provide this support for numerous clients as a recognized third-party GMP and Data Integrity expert in:
- FDA Form 483
- Untitled Letter
- Warning Letter
- Official Action Indicated (OAI) Status
- Mandatory and Voluntary Recalls
- Import Detention / Alerts 66-40 Detention without Physical Examination (DWPE) and Refusals
- Consent Decree (Permanent Injunctions)
- Application Integrity Policy (AIP)
- CRLs, RFIs and Additional Information (AI) requests
With TCG, support starts with quick mobilization of resources for remediation plan development and implementation, whether it be for all or selected quality subsystems, enterprise-wide, or within selected facilities. Throughout the process, we actively collaborate with our clients, which is necessary for the successful adoption and integration of sustainable solutions.
We strongly feel that a Simple, Efficient, and Compliant Quality System is not only a means to compliance but also makes good business sense. Quality Systems that we have remediated and/or implemented have shown a marked reduction in scrap, rework, rejected materials, repeat deviations, Field Alerts, and Recalls. These benefits far outweigh the cost of implementing a robust Quality System.
Regulatory Agency Response and Remediation Services Include
- Investigation and Corrective and Preventive Action (CAPA) Backlog Support
- Coordination with regulatory/legal counsel
- Third Party Batch record verification/certification to support product release
- Third-Party Retrospective Forensic Review of NDA, ANDA for FDA Commitments
- Regulatory review of 510(k) submissions
- Support during meetings with regulatory agencies
- Agency reporting for status/progress updates
- General Quality System Improvements including, but not limited to:
- Change Control and Document Control Systems
- Training
- Quality Event (e.g. Deviation and OOS) and Investigation lifecycle
- Supplier Qualification and Management
- Sterility Assurance
- Data Integrity
- Qualification and Validation (methods, process, cleaning, computer systems, etc.)
- Risk Management
- Quality system metrics
- Remediation planning
- Investigator Training and Certification Programs
- Management of Third-Party supplier auditing program for clients
- Laboratory and Manufacturing-focused OOS and Investigation training
- Manufacturing Quality Assurance Oversight
- Sterile Manufacturing Quality Oversight (MQA)
- Contamination Control Strategy Development
- Interim Staff Augmentation
- Training/Coaching/Mentoring for Laboratory, Manufacturing and Quality
Project Management
TCG provides project management oversight on remediation efforts to ensure all aspects stay on schedule and that deliverables are achieved within a timely manner. The project manager tracks applicable regulatory commitments along with other Quality System remediation efforts as part of the remediation program. They monitor ongoing remediation activities and additional items that may emerge from existing Quality System remediation activities such as Investigations, CAPAs, etc.; therefore, ensuring that these activities are accounted for and incorporated into the remediation effort.
Contact Us
Have Questions?
Thank you for your interest in Toscano Consulting Group (TCG). Do not hesitate contacting us for any of your consulting needs.
Toscano Consulting Group
Phone: (786) 201-3663 Email: operations@thetcg.org
Hours
Mon | 09:00 am – 05:00 pm | |
Tue | 09:00 am – 05:00 pm | |
Wed | 09:00 am – 05:00 pm | |
Thu | 09:00 am – 05:00 pm | |
Fri | 09:00 am – 05:00 pm | |
Sat | Closed | |
Sun | Closed |