FDA FORM 483, EIR AND EMA RESPONSE

It is critical to the ongoing success of any organization to be able to effectively respond to a regulatory inspection report with a thoughtful and cogent plan for remediation. Pharmatech has the complete product development lifecycle compliance experience, led by former FDA consumer safety officers (investigators, compliance officers, and directors) and European QPs, to generate an effective response to any regulatory action. Our experts, will highlight for you the near term and long term impact of remediation commitments, and work with you to establish and execute a plan that is both effective from a compliance perspective, but will also be consistent with the needs of your business and organization.

WARNING LETTERS AND CONSENT DECREES

Warning Letters and Consent Decrees are significant regulatory actions that require a focused plan that is coupled with a comprehensive understanding of the FDA’s compliance philosophy with a true appreciation for the  strengths and weaknesses of your business. Many of these regulatory actions result in onerous and inflexible operating and compliance systems that can make it very difficult to ensure consistent production of a high quality product.   Pharmatech’s team of former FDA consumer safety officers (investigators, compliance officers, and directors), with our industry expertise, can  produce a remediation plan tied to the success of your business.  These plans have been found to be effective, efficient, and capable of demonstrating to the agency that you have a sustainable and fully compliant system.