Regulatory Compliance

The New Compliance Environment
The Regulatory environment today is more complex than ever. As the FDA attempts to redefine its relationship and expectations from industry, the challenges of managing regulatory compliance only escalate.

Two critical initiatives have changed the paradigm for quality and regulatory compliance within the industry today. The Critical Path Initiative is intended to lean the drug and medical device development process and bring safer products to the marketplace with a lower candidate failure rate. The Risk-Based cGMP Initiative seeks to establish a regulatory oversight structure based upon risk mitigation through the application of scientific methodology. Couple this with new agency leadership and the uncertainty in establishing regulatory compliance has never been higher.

To achieve this transformation, the FDA has issued a series of new guidance documents intended to assist industry in interpreting these new requirements. This new guidance requires a strategic shift in thinking at all phases of the drug development lifecycle.

A New Solution: Compliance through Science
Pharmatech’s approach to regulatory compliance addresses the needs of this new regulatory model. Historically, compliance groups have leveraged former FDA specialists with the intent of determining non-compliance against specific elements of the cGMP guidelines. Understanding the agency’s perspective is a precursor to any assessment. Pharmatech’s Regulatory Compliance experts include former District and Regional Drug Specialists that were the architects of many of the policies being introduced by the FDA today.

Understanding a deficiency and proposing a resolution are two very different undertakings, recognizing that information alone will not ensure compliance. Pharmatech's industry specialists have decades of specific hands-on knowledge regarding all aspects of the drug-development process. This expertise allows us to craft a solution which will be effective, efficient and compliant.

The last piece of Pharmatech’s approach to regulatory compliance is the application of experienced industry experts from the biopharma industry to assist with the development of practical and compliant solutions which are designed to address your regulatory needs and your business needs. One of the challenges any firm has in implementing corrective actions is training and maintaining adherence to the new systems. We employ equipment specialists, technicians, analysts and operators that work side by side to make sure that corrective actions are successful. Together we establish an architecture and process to ensure that effective remediations are designed and implemented and that they may be sustained until they become part of an organization’s standard practice. We call this approach Compliance Through Science. This combination of top-tier former agency personnel with industry-leading experts and operational staff is unique to Pharmatech and is part of our proven methodology of achieving regulatory compliance success.

Pharmatech also recognizes the challenges facing the FDA and industry to coordinate and review compliance activities. In response, Pharmatech has developed a project management structure to leverage the strengths of each piece of the compliance puzzle. This framework puts Pharmatech at the center of the equation as a conduit between the Field Office, the Center and the Client.

The advantage for all parties is the objective evaluation of compliance remediation requirements and the development of metrics for long-term success. Pharmatech’s Regulatory Compliance Group provide guidance and communication of the issues to all parties in a uniform manner. Pharmatech’s sustained remediation capability provides the Center and Client with the assurance of a smooth transition to standard practice. This is one of many program structures which can be used effectively in a remediation scenario. Our experience with both industry and the agency allows us to tailor a solution for each client’s specific needs.

Our Regulatory Compliance Group can assist clients in responding to Agency inquiries and developing corrective action plans from a wide range of regulatory actions to ensure sustained compliance with domestic and foreign regulatory requirements.

Regulatory Compliance Group remediation and prevention capabilities:

Warning letters
Product Seizures
ANDA Application Withdrawals recommendations
Injunction Recommendations ,Establishing the post-injunction “Plan for Implementation” and Progress Metrics
Assessing the Adequacy of Application Integrity Plans (APIs)
Team leadership of Criminal (Title 18) Actions
Pre-approval and For-cause domestic and foreign inspection
Import Alerts resulting from violative Foreign Inspections
Regional and District FDA Training Courses

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Former FDA Personnel

Pharmatech's Regulatory Compliance Group consists of experienced former FDA District and Regional Drug specialists with considerable compliance expertise in preparing a wide range of regulatory action recommendations. Among others our key personnel include:

Leonard J. Farr - Senior Regulatory Consultant
Mr. Farr has over 41 years experience as a senior Compliance Expert with the FDA. He was designated as an Expert Drug Inspector by FDA for inspecting Quality Systems in the pharmaceutical and medicated feed manufacturing operations. Mr. Farr has received numerous citations from the agency for his performance and contribution to policy and education within the FDA and industry. Highlights include:

As a Drug Expert, performed pre-approval inspections of Drug Plants for NDA approvals in Dallas and Philadelphia Districts
Compliance Officer in Cincinnati managing Pharmaceutical Manufacturing CGMP violation cases and many other types of legal actions
Designed the Investigational Approach utilized by the National Steroid Taskforce yielding over 250 felony prosecutions in association with the FDA, DOJ, US Customs, Postal Inspection Service as coordinated by Dennis P. Degan.

Mr. James Sibert
Mr. Sibert has over 15 years experience with the FDA holding a number of senior management positions within the agency and in industry. Mr. Sibert is an expert in all compliance elements of the drug development lifecycle with particular expertise in laboratory compliance. Highlights include:

Directly responsible for NDA, ANDA, PMA, IND etc. approvals resulting in over 30 application/facility approvals in drug and medical device areas
Served as the U.S. Agent for several foreign pharmaceutical operations
Provided FDA readiness training to thousands of individuals in industry
Managed activities for the FDA’s testing laboratories