August 7, 2025
Envol Biomedical welcomes Dr. Daniela Schwotzer as Director of Toxicology, strengthening its GLP toxicology services and expanding preclinical capabilities across respiratory, CNS, and ocular indications.
Envol Biomedical is entering a bold new chapter in its evolution—one marked by its transition into full GLP toxicology services, expansion into new therapeutic areas, and a continued commitment to excellence in nonhuman primate (NHP) studies.
Envol Expands GLP Capabilities by Introducing to Dr Daniela Schwotzer
Leading that charge is the newest addition to the team, Dr. Daniela Schwotzer, a board-certified toxicologist with deep experience across regulated studies, global CRO environments, and inhalation toxicology.
As Envol’s new Director of Toxicology, Dr. Schwotzer is poised to significantly enhance the company’s capabilities in GLP study design and execution. With over 120 GLP programs under her belt, many of which led to successful IND submissions, her leadership marks a key turning point for Envol’s growing portfolio of preclinical services.
Strengthening GLP Toxicology at Envol Biomedical
For biotech sponsors evaluating CRO partners for IND-enabling toxicology, GLP compliance and experience are essential. Envol’s investment in expanding its GLP capabilities demonstrates a commitment to scientific integrity, regulatory excellence, and sponsor trust.
Dr. Schwotzer, a Diplomate of the American Board of Toxicology (ABT), brings rare and highly sought-after credentials to the role. Her background spans inhalation toxicology, diverse species models, and complex study oversight. Most notably, her leadership ensures clients will have an experienced scientific authority managing and guiding GLP programs from design through execution.
“Putting my name on a GLP study signals to sponsors that the experience is there,” she explained. “There’s confidence that the work will meet regulatory standards, because I’ve done it before—many times.”
A Scientific Leader with Global Perspective
Dr. Schwotzer’s career began in Europe, where she earned her Master’s in Toxicology from the University of Düsseldorf and completed a PhD in Inhalation Toxicology at the Fraunhofer Institute. Her journey then brought her to Lovelace Biomedical in New Mexico, where she led toxicology studies for nearly seven years, eventually earning her DABT certification and managing a broad spectrum of GLP and non-GLP studies.
This global perspective—bridging regulatory practices, scientific rigor, and operational complexity—positions her uniquely to elevate Envol’s quality systems and study operations as the company scales.
Expanding Capabilities Across Therapeutic Areas
While Envol is best known for its expertise in nonhuman primate preclinical models, the organization is actively expanding its capabilities across additional indications and delivery methods. Dr. Schwotzer will be instrumental in this evolution, helping to build new service offerings in:
- Inhalation Toxicology
- CNS and Ocular Delivery
- Respiratory Studies
- New Species and Study Types Beyond NHPs
With prior experience overseeing studies involving dogs, rats, mice, and ferrets, she brings both breadth and depth to the preclinical landscape at Envol.
What Sponsors Can Expect From Envol’s GLP Transition
Clients working with Envol in the coming months can expect to see measurable enhancements to study execution and documentation—particularly in GLP environments. Dr. Schwotzer will lead scientific and operational training for junior study directors, review and revise toxicology protocols, and help establish a best-in-class foundation for regulated studies.
“GLP is a discipline. I’ve been through every hiccup and challenge that comes with these programs, and that experience helps avoid mistakes before they happen,” she shared.
Importantly, Envol’s quality assurance team is also expanding in parallel, reinforcing a top-down culture of compliance and scientific precision.
Why Envol Biomedical Stands Apart
As Dr. Schwotzer noted, many CROs attempt to be everything to everyone—and in doing so, sacrifice depth for breadth. Envol’s approach is different. The company’s focused expertise in NHPs and targeted expansion into select areas allows it to deliver the precision, quality, and speed that biotech sponsors need.
“It’s better to be exceptional at a few things than average at many,” she said. “And Envol is building something exceptional.”
Looking Ahead: A Vision for Growth and Mentorship
Dr. Schwotzer’s goals extend beyond operational excellence. She envisions Envol not only as a center of scientific rigor but also as a hub of professional growth, where rising study directors can be mentored and trained to become the next generation of toxicology leaders.
“I’m excited to teach, to grow the team, and hopefully guide some of them to achieve DABT certification down the road,” she said. “In a few years, we’ll have a powerhouse team.”
Final Thoughts: Why Now Is the Right Time to Work With Envol
Envol’s shift into GLP services, combined with strategic hires like Dr. Daniela Schwotzer, positions the company to deliver greater scientific value and regulatory readiness for clients preparing IND-enabling programs.
“We’re not building a CRO that cuts corners,” she emphasized. “We’re building a CRO that learns from experience, invests in quality, and aims for perfection in every protocol.” With that mindset—and a team of seasoned experts—Envol Biomedical is ready to help sponsors advance smarter, faster, and with confidence.