Emerging Company Representation
The company struggling to become established has any number of legal challenges, from determining and establishing its corporate structure to various rounds of funding and eventually perhaps an IPO or the sale of the business or a product line. We assist companies in meeting these challenges, and we also draw on the extensive in-house legal experience of our corporate lawyers to act as general counsel to companies not yet big enough to have their own internal lawyers.
As companies grow, we assist them by advising senior management and directors on issues ranging from corporate governance, including Sarbanes-Oxley compliance, to mergers and acquisitions. Working side-by-side with a corporate lawyer who understands the challenges and will assist the company in making appropriate decisions is integral to a company’s success.
We help emerging company clients focus on and protect the value of their intellectual property at the earliest possible stage of a company’s life. Our significant litigation experience can help companies to protect intellectual property as they grow and succeed. The cross-disciplinary experience of lawyers in Porzio’s Life Sciences Industry Group provides clients with sound advice on regulatory, transactional, litigation, intellectual property, and other key business issues. We help emerging company clients anticipate potential problems before they arise, avoid common mistakes, and successfully confront the challenges they face at different stages of their development.
The emerging company turns to Porzio’s lawyers for further guidance in the following regulatory compliance areas:
- Compliance Program Development Porzio develops comprehensive compliance programs for Life Sciences companies according to the OIG Guidance for Pharmaceutical Manufacturers, the Prescription Drug Marketing Act and state statutes and regulations. We draft written standards of conduct as well as policies, procedures and protocols demonstrating a company’s commitment to compliance. Further, we frequently conduct education and training programs on a company’s compliance program to all affected employees.
- Licensing and Distribution Porzio counsels clients on the particular laws related to the wholesale distribution of prescription, device, and over-the-counter (OTC) products in all 50 states and the District of Columbia. Our attorneys have extensive experience analyzing the individual state wholesale distribution statutes and regulations and advising clients on whether a license to manufacture or distribute a product is required and how best to obtain any necessary licenses. Our significant experience with the various state boards of pharmacy allows Porzio to provide clients with the most relevant and current information. Porzio also counsel clients on the implications of federal initiatives in the wholesale distribution arena.
- Sales Force and Management Training Porzio routinely conducts sales force and executive management training on a variety of sales and marketing-related topics, including FDA-regulated promotion (including off-label issues), permissible conduct of sales representatives under the anti-kickback statutes and the PDMA, and requirements and protections under federal and state False Claims Act. We also provide training on the principles of the PhRMA Code, AdvaMed Code, OIG Guidance for Pharmaceutical Manufacturers, AMA Guidelines and ACCME Standards. In addition, our attorneys frequently work with the legal, compliance, marketing, and distribution departments in developing training programs tailored to the department’s specific needs or concerns. Porzio not only conducts in-person training, but also utilizes a variety of remote training methods. For example, we work closely with our subsidiary Porzio Pharmaceutical Services to provide interactive web-based training through e-Porzio, which offers testing and certification capabilities.
- State Reporting Our attorneys have extensive experience in counseling Life Sciences companies of all sizes on aggregate spend tracking and reporting requirements and solutions. Our services include: interpretation and application of existing state law requirements to business practices; gap analyses of existing data sources, documentation, and aggregate spend procedures; development of policies, procedures, and business rules governing interactions with healthcare professionals and organizations in compliance with state law requirements; design and implementation of aggregate spend solutions to comply with existing and pending aggregate spend tracking and reporting requirements; and preparation of state disclosure reports.
