Regulatory & Compliance
Life sciences companies face compliance and regulatory requirements and restrictions unique to their industry. Often times a long-term vision of the compliance/regulatory landscape is necessary to ensure that commercialization strategies are fully achieved.
Our consultants have deep-seated knowledge of the regulatory hurdles companies face while commercializing a product. Our team has experience working collaboratively with leadership teams on developing initial label strategies including FDA inquiries and requests. We also help walk clients through the often complex and highly nuanced license/registration process and ensure that the correct documentation is in place prior to beginning commercial activities.
Our team also knows that in today’s ever-changing regulatory landscape, establishing an effective compliance and ethics program is a business necessity in order to protect life sciences companies. At its core, an effective compliance program protects companies by detecting and preventing improper conduct and promoting adherence to the company’s legal and ethical obligations. In addition, an effective compliance program shows a company’s commitment to responsible conduct. While there is no “one-size-fits-all” program for every company, there are several core components that must exist to ensure compliance program effectiveness. Our team is experienced at developing fit-for-purpose compliance solutions designed specifically for specific business needs. We also review established compliance and ethics programs to determine whether any gaps exist or revisions are needed.