Streamlined Pathways
to Clinical Trials

Trials mark a critical turning point in drug development.

Clinical Expressway ensures you reach this milestone by bringing together Benuvia’s formulation, analytical, and regulatory expertise to remove obstacles and pave a direct route to clinical readiness. From producing clinical trial materials to meeting strict compliance standards, we handle the complexities so you can focus on advancing your science. With Clinical Expressway, your journey to the clinic is as efficient and stress-free as possible.

Streamline your path to clinical trials

Clinical Expressway capabilities eliminate delays and ensure trials are equipped and compliant:

  • Clinical Trial Material Manufacturing
  • Regulatory and Quality Compliance Expertise
  • Stability Programs for CTMs
  • Streamlined Production and Packaging
  • Blinding Processes
  • Comparator Drug Sourcing
  • Ancillary Supply Management

Clinical Trial Material (CTM) Manufacturing

Benuvia offers GMP-compliant production of trial materials, including psilocybin and dronabinol, with scalable options for clinical studies. Our facilities are equipped to handle precise batch sizes, ensuring reliable, high-quality materials for every trial phase.

Stability Programs for CTMs

Our ICH-compliant stability chambers simulate various storage conditions to assess the shelf-life and integrity of clinical trial materials. This ensures that your study materials remain stable and compliant throughout the entire clinical trial process.

Regulatory and Quality Compliance Expertise

Benuvia’s Regulatory and Quality Assurance teams ensure trial materials meet FDA, EMA, and global standards. With thorough documentation and proactive oversight, we reduce risks and simplify clinical submissions, keeping trials on schedule.

Streamlined Production and Packaging

From formulation to final packaging, Benuvia integrates every aspect of trial material production, eliminating inefficiencies. This ensures consistent quality and timely delivery for clinical trials, helping your products move forward seamlessly.

Blinding Processes

Benuvia ensures the integrity of your clinical trials with precise blinding processes, including the creation of identical-looking active drug and placebo units. Our specialized packaging and labeling solutions maintain study confidentiality, minimize bias, and comply with rigorous regulatory standards, supporting reliable trial outcomes.

Comparator Drug Sourcing

We streamline the complex process of sourcing comparator drugs by partnering with licensed manufacturers and suppliers. Benuvia ensures the authenticity, traceability, and regulatory compliance of all comparator products, helping your clinical trials meet global standards while reducing logistical challenges.

Ancillary Supply Management

From syringes to lab kits, Benuvia handles the sourcing, packaging, and distribution of all ancillary supplies needed for your clinical trials. Our comprehensive management ensures timely delivery, compliance with regulatory requirements, and seamless support for trial operations, allowing you to focus on advancing your science.

Benuvia has been a game-changer for our trial readiness. Their seamless integration of comparator sourcing, ancillary supply management, and blinding processes ensured our clinical materials were delivered on time and met the highest regulatory standards. The team’s expertise and proactive approach kept our trial on schedule and gave us confidence every step of the way.

Global Biopharma Company

Clinical Operations Director

Speak with an Expert

Aruna Earla, Ph.D.

Director API Research and Development

Dr. Aruna Earla serves as the Director of the Research and Development group at Benuvia Operations, where she has been working since 2020. She is involved in the process development of Active Pharmaceutical Ingredients (APIs). With approximately 20 years of experience in pharmaceutical research, development, and manufacturing within the CRO and CDMO sectors, Dr. Earla brings a wealth of expertise to her role. She holds an M.S. in Organic Chemistry, an M.S. in Biotechnology, and a Ph.D. in Organic Chemistry. Her extensive experience in organic synthesis covers a wide range of chemistries, including cannabinoids and psychedelics. Dr. Earla’s contributions are significant, spanning from initial route scouting to the commercial manufacturing of APIs. Before joining Benuvia, she held Research Scientist positions at Alembic, Dr. Reddy’s, Olon-Ricerca Biosciences, and Nanosyn.

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