Critical Issue Management
for FDA 483 Warning Letters, Recalls & Safety Alerts
Agency Representation & Negotiation
Recalls, Field Corrections & Safety Alerts
483/Warning Letter/Consent Decree Resolution
Import Alert & Detention Removal Programs
Consent Decree Programs
Major Product’s Liability Litigation
Corporate or Multi-Facility Warning Letters
Monitoring of North American & European Union Regulatory Activities
What is Critical Issue Management?
Bioteknica can help resolve issues arising from FDA management mishaps including warnings, recalls, and safety alerts that may be issued by the federal agency by preventing these mistakes from happening.
We pride ourselves in following strict guidelines, ensuring all protocols, and noting every detail so that we are 100% compliant.
If you do find yourself now dealing with compliance management issues, we help clients like you by providing support in any of the above areas to ensure that you have the right risk assessments, management plan, and certifications needed in place and are able to resolve them.