From mock audits to warning letters to full remediation exercises, we have the insight to strengthen your compliance and minimize your risk position. We work with you to understand your current quality management systems and identify necessary changes, while ensuring data integrity is secure. Our regulatory compliance experts are trusted and distinguished leaders, who are committed to Pharmatech’s unique End-to-End and Top-to-Bottom philosophy; balancing regulatory requirements with business needs.
COMPLIANCE REMEDIATION – COMPLIANCE THROUGH SCIENCE®
Poorly designed and executed compliance remediation activities have the potential to cripple your organization, now and in the future. Pharmatech’s approach of achieving Compliance Through Science®, i.e. employing objective evidence to demonstrate compliance, is directly aligned with the FDA’s requirements for quality and product predictability. Our team, consisting of seasoned industry experts and former FDA consumer safety officers (investigators, compliance officers, and directors), have the knowledge and experience to craft focused solutions, based upon your organization’s capabilities and business requirements that will allow your business to rapidly move back into compliance and, more importantly, will allow your organization to sustain its compliance when back in the marketplace.
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.
QUALITY SYSTEMS DEVELOPMENT, AUDITS AND GAP ASSESSMENTS
QUALITY RISK MANAGEMENT