Veristat to Acquire Certara’s Regulatory Affairs and Medical Writing Business
Veristat, a science-first, full-service clinical research organization (CRO) and consultancy specializing in advancing complex therapies from early development through regulatory submission, has announced its intended acquisition of Certara’s Regulatory and Medical Writing business. The strategic move is designed to significantly strengthen Veristat’s global regulatory, medical writing, and submission capabilities, while expanding its capacity to support biopharmaceutical innovators navigating increasingly complex development pathways.
The transaction is being supported by WindRose Health Investors, LLC, a New York-based healthcare-focused private equity firm and long-standing partner of Veristat. WindRose continues to play an active role in supporting Veristat’s long-term growth strategy and its mission to accelerate the delivery of life-changing therapies to patients worldwide.
Once completed, the acquisition will bring more than 200 experienced regulatory and medical writing professionals into Veristat’s global organization. These experts are widely recognized in the industry for their “white-glove” advisory approach and deep expertise in authoring high-quality clinical, non-clinical, and regulatory documentation across the entire drug development lifecycle. Their integration is expected to meaningfully enhance Veristat’s ability to support clients with end-to-end regulatory strategy, submission planning, and documentation services.
Strengthening a science-driven CRO platform
Veristat has built its reputation over more than three decades as a specialized CRO that focuses on complex clinical development programs, particularly in areas where regulatory pathways are challenging or evolving. The company has consistently emphasized scientific rigor, statistical expertise, and regulatory insight as core pillars of its service model.
According to Veristat leadership, this intended acquisition aligns directly with the company’s long-term strategy of building an integrated, science-led platform that can support sponsors from early-stage clinical planning through to global regulatory approval.
“Over the past 30+ years, Veristat has strategically invested in organizations, people, and resources to help our clients solve their most complex clinical development, regulatory, and commercialization challenges,” said Kim Boericke, Chief Executive Officer of Veristat. “By combining our complementary strengths and talented teams, Veristat will have unmatched capabilities in biostatistics, medical writing, and regulatory affairs, made even stronger by a shared focus on science-based insights, strong client partnerships, innovation, and impact. We will be able to bring even more life-changing medical therapies to patients with unmet needs—and that’s an exciting prospect for all of us.”
The acquisition is expected to significantly deepen Veristat’s already established expertise in regulatory writing and submission management, a critical component of modern drug development programs. Regulatory documentation is often one of the most complex, time-consuming, and resource-intensive aspects of bringing a therapy to market. By expanding its in-house capabilities, Veristat aims to reduce friction for sponsors and improve the efficiency and quality of global submissions.
Certara’s Regulatory and Medical Writing business: a strategic addition
The acquired unit from Certara is known for its specialized focus on regulatory writing, clinical documentation, and strategic regulatory consulting services. It has built a strong reputation for supporting pharmaceutical, biotechnology, and medical device companies through all phases of development, including preclinical documentation, clinical trial submissions, regulatory filings, and post-marketing requirements.
The team’s expertise spans a wide range of therapeutic areas and regulatory jurisdictions, enabling clients to navigate differing global requirements, including those of the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other international regulatory authorities.
With more than 200 professionals expected to join Veristat, the acquisition represents a substantial expansion of the company’s global workforce and intellectual capital. These experts bring decades of combined experience in regulatory science, medical writing, and submission strategy, further enhancing Veristat’s ability to support complex, multi-regional clinical programs.
Strategic alignment and industry impact
The combination of existing capabilities with Certara’s Regulatory and Medical Writing business is expected to create a more integrated and comprehensive service offering. In particular, the expanded organization will be positioned to provide:
- End-to-end clinical development support
- Integrated biostatistics and regulatory writing services
- Streamlined global submission strategies
- Enhanced expertise in complex therapeutic areas
- Improved efficiency in regulatory documentation workflows
This integration is particularly significant in the current biopharmaceutical landscape, where development timelines are under increasing pressure, regulatory expectations are evolving, and the complexity of clinical programs continues to grow. Companies developing advanced therapies—such as gene therapies, cell therapies, oncology treatments, and rare disease drugs—often face heightened documentation requirements and regulatory scrutiny.
By combining scientific, statistical, and regulatory writing capabilities under one roof, aims to reduce inefficiencies caused by fragmented service providers and improve the overall quality and consistency of regulatory submissions.
Role of WindRose Health Investors
The transaction is also notable for the continued involvement of WindRose Health Investors, LLC. As a healthcare-focused private equity firm, WindRose has been a key strategic partner to Veristat, supporting its expansion through both organic growth and targeted acquisitions.
WindRose’s backing underscores investor confidence in business model and its long-term positioning within the global CRO and clinical development services market. The firm’s continued involvement is expected to provide financial stability and strategic guidance as integrates the new business unit and expands its global footprint.
Industry context and competitive positioning
The clinical research and regulatory services industry has seen increasing consolidation in recent years, driven by growing demand for integrated service providers capable of managing end-to-end drug development processes. Sponsors are increasingly seeking partners that can offer not only operational execution but also strategic regulatory insight and scientific expertise.
In this context, Veristat’s acquisition of Certara’s Regulatory and Medical Writing business reflects a broader industry trend toward consolidation and capability expansion. By combining complementary expertise, CROs are seeking to differentiate themselves in a competitive market where speed, accuracy, and regulatory success are critical success factors.
The expanded Veristat organization is expected to be particularly well positioned to serve mid-sized biotech companies, emerging biopharmaceutical innovators, and larger pharmaceutical sponsors seeking specialized support for complex development programs.
Operational continuity and next steps
Until the transaction is finalized, both Veristat and Certara’s Regulatory and Medical Writing business will continue to operate as separate and independent entities. Both organizations have confirmed that they will continue to support existing clients without disruption throughout the transition period.
The acquisition is expected to close in the second quarter of 2026, subject to customary regulatory approvals and closing conditions. Following completion, integration efforts will focus on aligning operational processes, unifying service offerings, and leveraging combined expertise to enhance client delivery.
Veristat’s intended acquisition of Certara’s Regulatory and Medical Writing business marks a significant step in the company’s evolution as a leading science-driven CRO. By adding more than 200 experienced regulatory and medical writing professionals to its organization, Veristat is positioning itself to offer a more comprehensive, integrated, and efficient suite of clinical development services.
Supported by WindRose Health Investors, the move strengthens Veristat’s long-term growth strategy and reinforces its mission to accelerate the development of innovative therapies for patients with unmet medical needs. As the pharmaceutical and biotechnology industries continue to evolve, the combined capabilities of Veristat and Certara’s regulatory team are expected to play an increasingly important role in helping sponsors navigate complex regulatory environments and bring new treatments to patients more efficiently and safely.
About Veristat
Veristat is a full-service CRO and consultancy that helps life sciences companies bring novel therapies to market fast. With 30 years of experience and support in more than 100 regulatory approvals and deep expertise in rare disease, neurological disease, oncology, and advanced therapies, Veristat integrates strategic planning, regulatory insight, and trial execution to overcome complex challenges and accelerate success. From early planning through approval, Veristat delivers tailored solutions that drive meaningful outcomes for patients worldwide. For more information, visit www.veristat.com.
About Certara
Certara accelerates medicines using proprietary biosimulation software, technology, and services that transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.
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