Knowing the rules is not enough to navigate regulatory compliance minutiae—you need to understand them like a regulator does. Health Policy Associates (HPA) has built its reputation on this perspective, leveraging its expertise to guide clients through the intricate requirements of agencies like the Food and Drug Administration (FDA). This philosophy stems from Founder Vincent Bucci, who brought invaluable insights from his time at Pfizer, where he tackled compliance challenges head-on. This expertise earned his newly founded consultancy an invitation to assist with the FDA’s Application Integrity Policy—a program addressing companies submitting misleading or falsified data. HPA’s work involved examining nearly every aspect of a medical device or biotech company’s operations that contributed to regulatory submissions—clinical study protocols, electronic data capture (EDC) systems, standard operating procedures (SOP), quality management systems, interactions and manufacturing processes. Essentially, HPA scrutinized everything that could potentially cast a submission in a negative light from the FDA’s perspective. HPA is perhaps the only medical device consulting firm with services covering regulatory, clinical, quality systems and manufacturing assistance for companies of all sizes. For early-stage companies, HPA is truly a “one-stop” shop. “The arrangement allowed us to build a unique relationship with the agency and gain insights into its culture and thought process. It also gave us a firsthand view of how companies encounter regulatory challenges. Once we identified these issues, our role was to develop and implement strategies to resolve them,” says Dan Howell, VP of business development. Today, that foundational experience shapes HPA’s role as a trusted partner for biotechnology and medical device companies. From regulatory pre-submissions to complex filings like Investigational Device Exemptions (IDE), 510(k) premarket notifications and premarket Approvals (PMA), HPA ensures companies avoid costly missteps while building a foundation for long-term success. The Roadmap to Regulatory Readiness Effective preparation is a cornerstone of success in the life sciences industry, especially for small startup medical device companies, which comprise a significant portion of HPA’s client base. Operating on limited financial reserves, these companies face the dual pressures of innovation and efficiency. Shaving months and even years off development timelines to final product approval can conserve precious resources, minimize cash burns and keep them on course toward achieving their goals.
Biomanufacturing
Polbionica is a mission-driven pioneer in regenerative medicine and transplantology, advancing the clinical use of 3D bioprinting to address critical gaps in organ replacement and tissue engineering. Based in European Union, the scientific and technological innovator creates functional tissue models and organ prototypes designed for human transplants. Its innovations are leading to the societal transformation of medicine, elevating biotechnology and 3D bioprinting from services to civilizational milestones. “We are pushing the boundaries of what’s biologically and clinically possible, offering new solutions where conventional medicine has reached its limits,” says Michał Wszoła, CEO. Polbionica’s flagship achievement is the world’s first fully functional Bionic Pancreas—ATMP (Advanced Therapy Medicinal Product). The living, bioprinted organ with functional vasculature can produce insulin and glucagon, offering a groundbreaking therapeutic solution for brittle, complicated diabetes and chronic pancreatitis. Sized like a natural pancreas and designed for minimally invasive transplantation, the Bionic Pancreas-ATMP restores metabolic control, reduces pain, cancer risk, and helps patients regain independence while lowering healthcare costs. .
Regulatory and Compliance
The road from discovery to patient care is filled with twists and turns. This journey demands navigating regulatory shifts, advancing R&D, securing investor support and strategically positioning for commercialization or a successful exit. Facet Life Sciences stands as the perfect support for early-stage companies, helping them chart a clear and strategic path forward from drugs, biologics, and devices. This regulatory affairs and development advisor exclusively works with smaller companies to truly support them at every stage — from investor acquisition to bringing lifesaving innovations to patients. The company is experienced in all therapeutic areas, with specialties in radiopharmaceuticals, psychedelics, ophthalmics, CNS, and oncology. Its broad scientific knowledge base combined with clinical support, statistical analysis, commercialization strategies and investor engagement enable it to provide comprehensive end-to-end support focused exclusively on smaller companies and non-profit research centers. Facet’s expertise and experience positions it as an advisory powerhouse that helps companies turn their R&D efforts into lifesaving innovations, aligning with FDA requirements and company goals. “We look at the science, the data that supports that science, and the ability to tell a compelling story about what that data truly translates into,” says Ken VanLuvanee, president. This time-tested model drives Facet’s excellence. Its approach presents regulators with a clear, data-backed case that meets safety and efficacy standards—one that regulators can confidently support in bringing a therapy to the clinic or market. Facet helps clients prepare Investigational New Drug (IND) applications and guides their interactions with the FDA from pre-IND meeting to marketing approval/launch. Its expertise in chemistry, manufacturing and controls (CMC), nonclinical, clinical, and regulatory ensures a complete solution as a product progresses through development. This scientific foundation is further strengthened by statistical clinical trial optimization, enabling companies to refine study designs, shorten trial durations, and reduce costs. The goal is to simplify the entire process for biotech firms, driving reductions in time, resource, and expense. Facet helps clients move efficiently from discovery to development, then to market or divestiture at any stage. It integrates financial and commercial insights to drive long-term value at each development stage by applying health economics research (HEOR) to align clinical trials with market potential, ensuring a client’s efforts are in line with market and investor interests as the foundation for either divestiture or product launch. By tying investment strategies to development and commercialization expertise, Facet ensures decisions that are both scientifically and commercially sound. One example involved a small biotech firm developing a promising compound. The client faced significant challenges, including limited resources, regulatory uncertainty and an unclear market path. Facet stepped in to assemble a team of regulatory, statistical and market experts who analyzed the available data and identified the most viable patient population. Through a structured evaluation of FDA approvability, market potential and patient availability, Facet helped the client determine the best indication to pursue..
When regulatory strategy is embedded into clinical trial design, the difference is tangible—faster timelines and an easier path to market. CCS Associates (CCSA) has designed some of modern medicine's most complex and impactful clinical programs for more than four decades, fueling the development of life-altering diagnostic, preventive and therapeutic medical products. A woman-owned small business, CCSA provides leading-edge advisory and regulatory services in product discovery and development. Over the years, the company has played a key role in designing industry-grade master protocols and investigational new drug applications (INDs) like those for Lung-MAP and I-SPY 2, which have been in use for over a decade. Backed by in-depth expertise, it empowers nimble biotech startups and major government institutions to lead every stage of clinical development with clarity and confidence. “Our vast experience in handling regulatory affairs for several ground-breaking master protocols and INDs gives us a competitive edge,” says Linda A. Doody, Executive Director. A highly skilled leadership team with deep scientific knowledge is at the heart of the company’s operations. Dr. Doody has been with CCSA for over 35 years and has built the regulatory and safety departments from the ground up. Its unparalleled scientific acumen is the result of government partnerships, including programs with the National Heart, Lung and Blood Institute (NHLBI) and NIH’s Blueprint Neurotherapeutics Network (BPN). Many of CCSA’s commercial clients are referrals from previous government-sponsored collaborations. They rely on its hands-on approach and scientific depth to improve the odds of clinical trial success. In one instance, a company operating with a skeleton crew partnered with CCSA through the BPN program. Today, the organization runs phase 3 trials in multiple countries, with CCSA supporting its U.S. regulatory strategy. Long-term commitment is a core principle at CCSA. It guides early-stage innovators through complex clinical trials by staying on board beyond IND submission. Whether it’s ophthalmologic treatments, neurodegenerative disease therapeutics, cancer prevention or age-related drug development, the company delivers unparalleled scientific and strategic support throughout the entire R&D process. “We very often function as members of our clients’ teams, integrating ourselves into projects and working very closely with clients’ staff,” says Dr. Caroline C. Sigman, President and CEO. CCSA’s proficiency in managing INDs has been instrumental in conceptualizing and executing numerous master protocols. The I-SPY 2 platform’s transformational impact on breast cancer research is a perfect example. Designed to simultaneously evaluate multiple treatments using a shared control arm and adaptive design, I-SPY 2 delivers real-time insights and accelerates drug development..
Regenerative Medicine
Microbiological Considerations for Achieving Drug Manufacturing Excellence
Jessica Wilson Rayse, Assoc Director of Product Management, Accugenix, Charles River Laboratories [NYSE: CRL]
Cell and Gene Therapy
Meeting The Challenges Of Modern Healthcare Compliance
Vanessa Casella, Program Manager, Compliance Risk & Data Service, UChicago Medicine
Cell and Gene Therapy
Construction and Maintenance Risks: It's Never Just Removing a Ceiling Tile
Nancy Warren, MHA, MLT (ASCP), CIC, Infection Control Manager, Fox Chase Cancer Center
Regulatory and Compliance
Patient safety and management
Eileen Jaskuta, Vice President of Quality Patient Safety, Anne Marie Browne, System Director for Patient Safety and Quality, Main Line Health
Regulatory and Compliance
Silo Operations: A Detrimental Force in Healthcare
Dino Scanio, DHA, MPH, Multiservice Hospital Director of Clinics, Driscoll Children’s Hospital
IN MY OPINION
Regulatory and Compliance
Anchoring Quality Care with Collaboration
Amber Howard, Director of Corporate Risk Management, Infirmary Health
LAST WORD
Regenerative Medicine
A Lens Switch for Improved Compliance Effectiveness
Jordan Muhlestein, Corporate Counsel, Intermountain Health
IN FOCUS
Advancing Drug Development with 3D Bioprinted Tissue Models
The field of 3D bioprinting stands as a monumental frontier in biomedical science, rapidly transforming the capabilities in tissue engineering,
3D Bioprinting's Role in Combatting Donor Shortages
3D bioprinting holds promise in addressing organ donor shortages by creating patient-specific tissues.
EDITORIAL
The Tech Convergence Transforming Life Sciences
Another revolution is unfolding. 3D bioprinting is breaking new ground as advances in tissue engineering meet the precision of AI. It has moved beyond experimental curiosity to become a core enabler in personalized healthcare and regenerative therapies. A most compelling shift this year has been the convergence of AI with bioprinting platforms, where machine learning models are helping refine cell-laden bioink formulations and optimize printing paths for higher fidelity, cell viability and reproducibility. This marriage of automation and biology is reducing the trial-and-error phase that once slowed the field.
Driven by these trends, the regulatory services market is projected to grow at a CAGR of 8.6 percent by 2034. Meanwhile, the 3D bioprinting industry is expected to expand from $2.55 billion in 2025 to $8.57 billion by 2035, registering a CAGR of 12.9 percent.
The magazine features a thought leadership piece by Amber Howard, Director of Corporate Risk Management at Infirmary Health, discussing the importance of cross-departmental collaboration and a just culture in advancing patient safety and risk mitigation. Additionally, it includes insights from Vanessa Casella, Program Manager, Compliance Risk & Data Service at UChicago Medicine, on the value of collaboration and continuous learning in ensuring patient-centered, compliant care.
We also spotlight the stories of regulatory services companies delivering solutions that drive innovation. One such company is Health Policy Associates, which has provided consulting services to companies developing new medical device technologies, pharmaceuticals and biologics for over 30 years.
In this edition, featuring Top Regulatory Services Providers 2025 and 3D Bioprinting Solutions Company of the Year 2025, we hope you find the right partner to meet your organization's needs.
