With continual innovations in patient care delivery, organizations offering life sciences solutions must be simultaneously nimble while also navigating the complexities of the US and global healthcare systems. Pinnacle provides an array of services to support a variety of life sciences organizations, including medical device, pharmaceutical, biologic, and tissue companies. Our team of experts – including our life science professionals at Pinnacle’s affiliate company MRC Global (MRC) – deliver comprehensive solutions for regulatory, quality, clinical, transactional, physician leadership, and key opinion leader advisory services. MRC is a trusted advisor to US and global life science companies and works in collaboration with Pinnacle’s other service lines to provide an unparalleled range of consulting, valuation, regulatory compliance, and value-based services. We have blended the expertise of MRC’s professionals with the service offerings provided by Pinnacle’s professionals to develop a life science service line that goes beyond regulatory management and extends to valuation, strategy, and other consultative advisory services. Our experience across these types of projects includes a variety of life science developments such as medical mobile applications, implants, biologics, capital equipment with software, personal protection equipment, and dental devices.
Life sciences innovations play an increasingly critical role in healthcare delivery. As a result, organizations offering these advancements must meet a variety of governmental requirements to remain compliant with a myriad of healthcare-related requirements. Pinnacle’s team of experts offer services that involve detailed knowledge and experience with regulatory submission and quality management systems pertinent to developments in life sciences technology. Our MRC team uses their consultants’ comprehensive expertise involving the regulatory submissions process to create and present submissions for approval and provide solutions for our clients’ regulatory needs. In addition, MRC’s team of consultants also address our clients’ quality system needs to ensure compliance with applicable regulatory requirements, which include domestic and international medical device regulations. As part of this process, our team provides quality assurance consulting services to advise and create a quality management system in compliance with regulatory requirements applicable to our clients’ products and services. Collectively, the reporting, submissions, and advisory services offered by Pinnacle provide our clients with the opportunity to gain full-service expertise from our experienced professionals whose focus remains solely in the realm of life sciences innovations.
With the life sciences industry evolving at an increased pace, market participants including biotechnology firms, pharmaceutical companies, and medical technology manufacturers must navigate a balance between prompt action to grow market share while also focusing on regulatory compliance, lower costs, and innovation. Our team assists life sciences clients as they aim to execute growth opportunities and work through business, regulatory, and scientific challenges. Our team at MRC offers comprehensive services to life sciences clients, including those such as:
In addition to PHC’s valuation services pertaining to provider compensation, business, and real estate, our team of subject matter experts regularly perform fair market value analyses to support life sciences transactions. Our life sciences team ensure that we provide our clients with the highest level of expertise by remaining up to date on legal and regulatory issues affecting healthcare valuations, including the Stark Law, Anti-Kickback Statute, Office of Inspector General (OIG) advisory opinions, and the Physician Payments Sunshine Act. By remaining current on these matters, PHC’s life sciences team aims to provide thought leadership and provider relations services that protect life sciences companies from significant risks related to regulatory scrutiny. For instance, our process minimizes risks while maximizing the potential surrounding the proper alignment with the every-important Key Opinion Leaders (KOL) and Healthcare Professionals (HCP) within the life sciences space. By providing a thorough and effective third-party review of KOLs and HCPs, life sciences companies can better develop these alliances and use this information to determine fair market value compensation. In addition to these critical thought leader roles, our team regularly supports our clients’ other life sciences needs including strategic transactions, litigation support, implant & human cellular-based offerings, co-branding allocations between sponsoring companies and participating physician groups, intellectual property valuations, and more. Our collective goal continues to entail collaborating with clients such that they are better equipped to navigate a complex marketplace and understand the key information necessary to make informed, yet compliant, decisions.
Pinnacle’s experts provide an array of valuation and transaction services to support our clients in developing and marketing new life sciences innovations. As part of these efforts, we regularly perform assessments pertaining to matters such as:
With the ever-increasing rate of life sciences innovations, market participants must navigate critical decisions at a rapid pace to remain nimble and competitive. To assist our clients with this complex balance, Pinnacle offers life sciences companies the necessary consulting services to perform at a high level, resonate with investors, and achieve strategic goals. Our team of strategy consultants and financial experts work with life sciences companies by providing market research, analytical modeling, and financial advisory consulting to support strategic initiatives and identify new opportunities. The collective goal of these efforts is to provide the resources and expertise our clients need to improve operations and enhance financial outcomes. Regardless of the business cycle stage (i.e., start-up, commercialization, or exit), we assist clients in strengthening core components that improve internal performance and elevate external market value.
Pinnacle provides the necessary consulting services to assist clients in the life sciences arena with planning and achieving strategic objectives. These projects range across a broad array of subject matters and include activities such as: