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Top 10 Regulatory Services Companies - 2022
Change is coming to the regulatory landscape in the life sciences sector. There is a lot of uncertainty as the market shifts and stakeholders try to understand the changes coming—making the need to plan more urgent than ever. From increased scrutiny of data integrity to the tracking of medicinal products, to changing political landscape and policy changes, today’s shifting regulatory priorities will need to be front and center as you develop your compliance strategies, actions, and investments in 2021 and beyond.
The Office for Life Sciences has pledged to increase R&D spending to 2.4% of GDP by 2027, with a goal of bumping this budget up in the future. As the life sciences industry advances at pace, so too does the regulatory environment in which it operates. In recent years we’ve seen an increasingly complex landscape of regulation in life sciences, with changes in science and technology creating opportunities as well as challenges when it comes to working in the industry.
Many life science organizations continue to develop risk and compliance initiatives despite ongoing regulatory uncertainty and the looming question of how Covid-19 will impact the sector.
Regulation in the life sciences industry aims to not only ensure the safety and efficacy of products, but also to ensure innovative therapies can pass through investigative and regulatory processes as quickly as possible. The challenges of this are myriad, particularly as technology continues to develop and scientific breakthroughs change the way drugs and devices are manufactured.
As more products become more complex, regulators must establish the best – and quickest – ways to evaluate them. These products include digital pills, connected medical devices and new molecular entities – all of which have the potential to improve public health if introduced to market safely and efficiently.
All of this rapid development and change means the regulatory landscape must acquire new skills and talent in order to meet market demand and stay ahead of the curve. This is great news for life sciences candidates who are prepared to up skill and adapt to changes in the market.
We present to you, “Top 10 Regulatory Services Companies - 2022.”
Nominate a Company
Our subscribers nominate the companies with whom they have collaborated and gotten results. If you think there is a company that deserves to be on our upcoming prestigious annual list of Top 10 Regulatory Services Companies , please write to us about them and the reasons you think they need to be on the list
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https://regulatory-services.lifesciencesreview.com/vendor/criterion-edge-assuring-comprehensive-expertise-in-regulatory-writing-cid-253-mid-18.html
We are more than writers. We are consultants, analysts, and scientists
—Laurie Mitchell, President
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Johner Institute supports medical device manufacturers in establishing ISO 13485:2016 compliant quality systems, defining global market access strategies, writing parts of technical documentation, human factors validation testing, and risk evaluation and management. The company combines its consultancy expertise with purpose-built tools and an e-learning platform to help medical device manufacturers stay updated with ever-changing regulations, standards, and directives across countries. This enables manufacturers to successfully complete audits and inspections quickly, so that they can bring innovative, high-quality and safe medical devices and software to market faster.
Immanuel Bader, CEOWe are on a quest of educating people in the regulatory field
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The company combines its consultancy expertise with purpose-built tools and an e-learning platform to help medical device manufacturers to stay updated with ever-changing regulations, standards, and directives across countries
We are on a quest of educating people in the regulatory field
—Immanuel Bader, CEO
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OPOS helps providers maintain Medical Board regulatory and CDC guideline compliance to continue offering chronic pain patients access to opioid therapies.
OPOS plans to productize its service for risk assessment into a standalone product for doctors, physicians, practices, and organizations to efficiently streamline their regulatory compliance program in a profitable manner
—Justin Kromelow, CEO & founder of OPOS
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WAYS Pharmaceutical Services is a regulatory submission management partner (RSMP) that provides expert services to life sciences teams. WAYS invests in the technology, processes, and skillsets required to maintain submission capabilities. Sponsors trust WAYS to organize, assemble, publish, and submit their regulatory submissions to health authorities. The company's team members have experience submitting to US FDA CDER, CBER and CDRH, Health Canada, European, and other regional health authorities.
Matt Stroschein, CEO, and Vanessa Phillips, Head of OperationsOur team members approach each client project with creativity, confidence, and empathy. That unique mix of skills makes their submission experience even more valuable to clients.
WAYS Pharmaceutical Services
Management
Matt Stroschein, CEO, and Vanessa Phillips, Head of Operations
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EG Life Sciences
EG Life Sciences, a company of Eliassen Group, delivers strategic consulting and innovative solutions for the pharmaceutical, biologic, medical device, and diagnostic industries
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Freyr Solutions
Freyr is a Global, Regulatory-focused solutions and services company for Life Sciences Companies supporting, Large, Medium, and Small firms
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NuEra Health Alliance Ltd.
NuEra helps improve efficiency, quality and planning, and reduce costs all while ensuring compliance with OPDP guidelines
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Pace Analytical
Pace Analytical has provides comprehensive analytical testing and emergency disaster response services to a broad range of clients, markets and industries
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Parexel
Parexel provides a suite of groundbreaking biopharmaceutical development services that help customers across the globe transform scientific discoveries into new treatments for patients
