Legal & Regulatory Compliance
The challenge of compliance with laws and regulations has exploded over the past 30 plus years, as state and federal governments and their agencies have attempted to exert ever-increasing amounts of prospective controls on society’s day-to-day operations. Often driven by the actions of “bad actors”, this “it cannot happen again” approach to regulation has resulted in an extensive fabric (or some would say patchwork) of overlapping, inter-connected and multi-layered laws and regulations.
The challenge of legal and regulatory compliance for trans-national corporations is especially difficult, as what was once local, state and federal regulatory schemes has now expanded to include international regulatory compliance efforts for even the smallest trans-national company.
Ensuring a company maintains a state of compliance with multiple legal frameworks requires identifying what the law is in each jurisdiction — a complex activity in itself — along with defining the relevance of the law and changes to each individual company’s unique situation. These activities are not simply a legal exercise — they require well-defined processes to ensure constant awareness of changes to laws and regulations across applicable jurisdictions, and, processes to distribute and ensure proper application of the current legal state. Developing a program that is successful is extremely difficult, and in practice, many companies have simply operated in an “ad hoc” awareness mode to understand current legal requirements.
Legal and regulatory compliance programs should, at a minimum, incorporate the following elements to ensure a baseline knowledge and application of requirements to their operation:
- Regulatory intelligence: a structured, formal approach to legal and regulatory requirements identification, and a determination / application of the requirements to affected areas within the organization;
- Regulatory Governance: an operating framework to ensure the application of the defined legal and regulatory requirements to the operations of the organization; and
- Audits, Assessments & Fraud Challenge Determinations: formal approaches to assess and correct existing operating models, with the added requirement for “fraud challenge” as most legal and regulatory frameworks were designed to ensure voluntary compliance, not to deter fraud.
The following are just a few of the legal issues and challenges The Garvey Law Firm can assist you with:
- State registrations (pharmaceutical, medical device, dietary supplement, API, dietary ingredients, etc.);
- FDA facility registrations;
- US Agency capability;
- Model document sets and implementation assistance;
- Corporate compliance program establishment and support;
- Corporate compliance investigations;
- Promotional claims reviews and support;
- Compliance program development, strategy, risk management and implementation;
- Healthcare provider compliance programs — Process, structure, validation / systems; and
- Import alerts and international products support.
Legal and regulatory compliance requires more than just skills of classical legal analysis. It requires the ability to identify risk; to apply process to ensure organizational adherence to legal standards and corporate statements of intent; and it requires the ability to understand where risks of failure within the organization may occur, to help remediate and resolve deficiencies in a manner that will reduce risk to minimal levels.