Whether you are implementing a brand new Comprehensive Compliance Program or reassessing your existing policies and procedures, we can help you reach your compliance goals effectively and cost-efficiently. Our clients appreciate our in-house experience, which ensures that our solutions are practical and workable and keyed to the way our clients do business.
Through risk assessments and gap analyses, policy and procedures, compliance counseling and unique training solutions, our clients enjoy a complete package that meets all of their compliance needs.
Comprehensive Compliance Programs
Our process begins with a review of your current operations and the development, implementation and management of a Comprehensive Compliance Program for your operations. We customize each program to each client, ensuring that the plan is place is appropriate for your products, markets, marketing plans and growth potentials.
On-Call Counsel to Business Units
While we serve as Chief Compliance Officer, we will be on-call for your various business units, ready to provide relevant, appropriate advice for their particular operational needs. This effort touches upon all your relevant business units, including sales, marketing, human resources, medical and clinical affairs.
Our program provides assistance to label communications, ensuring that products carry all necessary language given its FDA approval. We will serve as a labeling Review Team Member or provide ad-hoc counsel to these efforts as needed.
Allocation Assessment & Review
How your company spends its resources matters greatly, and our program will ensure that allocations made as part of patient assistance programs, grants and charitable giving maximize their intended purpose while also complying with relevant anti-bribery and anti-kickback laws governing the transmission of funds to third parties.
The education of your management and staff is critical to every compliance program since compliance is everyone’s responsibility, not simply one person’s job. Our program will touch upon all relevant training, including all-hands staff trainings, focused presentations, interactive and online resources and written guidance and handbooks (often in line with your HR efforts).
We will also work diligently to ensure external communications are in compliance with the law, paying particular attention to ad boards, CME programs, speaker bureaus and speaker programs, publication planning and the dissemination of medical and clinical trial information.