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Timely, Successful CE Mark & FDA Approvals for Aesthetic Indications
Successfully gaining CE Mark and FDA approval in the highly regulated field of dermal fillers and medical treatments/devices for aesthetic indications requires expertly executed clinical trials, highly accurate data collection and analysis, and a thorough understanding of the application process. HPA brings an unmatched breadth of expertise guiding medical and biotechnology manufacturers through the end-to-end development process of products for aesthetic indications, with specific expertise in dermal fillers, facial sutures, lasers, and neurotoxins and other injectables.
HPA Product Assurance Solutions
HPA’s Product Assurance team is a group of seasoned veterans, each with 20-30+ years in the medtech/biotech industry, with deep expertise in various aspects of product assurance, from operations to QA, RA, and compliance. HPA delivers solutions tailored to your specific product assurance needs, providing the precise expertise you need to successfully bring your medical device and biologic innovations to market.
HPA: Expert Guidance for Bringing Connected Health Innovations to Market
The use of technologies such as smartphones, social networks and internet applications is enabling patients, consumers and medical professionals to monitor and manage health and wellness in new ways. But bringing innovative new connected health products to market can be a complex process. Health Policy Associates (HPA) has the experience and expertise in connected health that can help your company navigate the tricky waters of this evolving space.
HPA Quality Assurance
Quality assurance becomes increasingly challenging as medical device, drug and biologic products move through the manufacturing process. With a QA team unmatched in the industry, Health Policy Associates (HPA) has been setting the gold standard in healthcare quality assurance for more than 23 years.
Helping Companies Bring Innovative Wound Care Solutions to Market
Successfully bringing innovative wound care solutions to market presents a number of unique challenges to medical device and biologic companies. For almost a decade, Health Policy Associates, Inc. (HPA) has been providing an unmatched breadth of clinical consulting expertise to the end-to-end process of bringing innovative new wound care therapies to market.
Data Management and Analysis
As industry standards have evolved over the last 20+ years, HPA has nimbly responded to changing requirements and the particular needs of our clients. In addition to our regulatory and clinical experience, HPA has robust database management capabilities including software development and a wide scope of data analysis services.
Helping Cardiovascular Companies Advance Novel Therapeutic Technologies
In HPA’s 23-year history, our team has worked with a wide variety of novel cardiac implants/devices and diagnostic tools. Whether your needs involve assistance with regulatory strategy/submission or clinical trial strategy, design and execution, HPA has the experience and expertise to get your technology from prototype to commercialization.
Advisors for Private Equity Firms and Corporate Strategic Investors Assessing Potential Growth Opportunities
With the highest understanding of healthcare technology, business strategy and due diligence, Health Policy Associates, Inc. (HPA) helps companies make decisions that drive successful business outcomes. Whether you’re trying to expand into new markets or looking for faster revenue growth, HPA provides fresh perspectives, relevant insights, and executional strategies.
Are You Prepared for the FDA? HPA Has the Experience You Need
Preventing and resolving compliance issues for new medical products requires specialized expertise in developing and implementing GMP (Good Manufacturing Practice) quality systems, understanding FDA and international and compliance requirements, and managing interactions with the FDA during audit and inspection processes.
Helping Biologic, Cellular and Gene Therapy Companies Advance Novel Therapeutic Technologies
Recent progress in cell and molecular biology, and improvements in our understanding of both stem and gene cell therapies have delivered us to a whole new frontier in medicine. HPA can provide expert assistance in overcoming the unique challenges associated with bringing these therapies to market.
Clinical Trial and Strategy Execution
HPA utilizes robust and streamlined processes that enable us to accomplish our commitment to quality and timelines within budget for your clinical trials. Our experienced team tailors a project plan to address the varied needs of each project and executes that plan seamlessly in partnership with your team.
Regulatory Expertise for US FDA and OUS Submissions
HPA provides solutions to regulatory challenges that confront the healthcare industry from FDA and other worldwide regulatory agencies. By working constructively with regulatory authorities, we seek solutions for our clients that resolve regulatory and compliance issues.