Compliance Triage & Regulatory Responses

Undesirable inspection finding? Been issued an FDA 483? Warning Letter? Product Recalls or Injunction? PSC can help you to better respond to the compliance bodies. Being an external organization with professional staff in handling regulatory responses, we can easily identify and address the issue which is not in compliance. We can assess each observation, develop an action plan to achieve immediate, short-term and long term correction and to prevent recurrence. We can assist by collecting and collating data, preparing and revising draft reports, coordinating the review process, and finally submitting the reports with appropriate forms and cover letters to the regulators. At the end of the day, it is TRUST that PSC wants you to establish with the regulatory bodies.