At Novum Pharmaceutical Research Services, we specialize in conducting Controlled Substance Studies with precision, compliance, and efficiency. With over 350 successful studies across various formulations, we are a trusted partner for advancing controlled substance drug development.
Why Choose Novum for Controlled Substance Studies?
- Approved for Handling Schedule II-V Products
- Proficient with DEA 222 Forms & Compliance
- Expertise in Complex Trial Designs
- Experience with Opioid Receptor Blockage (Naltrexone Co-Administration) and Naloxone Challenge Testing
- State-of-the-Art In-House Bioanalytical Laboratory
- Comprehensive Database of Study Volunteers
- Advanced Clinical Facilities: Fully equipped Phase-1 clinic with robust safety monitoring and controlled substance licenses.
- Proven Expertise in Regulatory Submissions and Approvals
Proven Experience Across Diverse Formulations
- Transdermal Patches and gels
- Buccal tablet/film, Lozenges
- Sublingual Tablet, film
- Oral tablet and capsule [Immediate-release (IR) and extended-release (ER)]
The Novum Advantage
With decades of expertise and a commitment to excellence, Novum delivers the results you need to bring innovative controlled substance therapies to market efficiently and compliantly.
- Quick startup capabilities.
- Proven success in meeting tight timelines.
- Real-time communication for quick updates.
- Flexible approach to meet unique project needs.
- Established track record of securing regulatory approval for complex and challenging submissions.
Contact us today to learn how we can partner with you to advance your controlled substance development program.