CoreRx™ is a contract pharmaceutical development organization that helps get you into the clinic faster, providing a complete spectrum of cGMP solutions for pharmaceutical dosage form development. Our wide range of support services, extensive instrumentation and rigorous quality systems provide timely results communicated in a clear, efficient and consistent manner.
Pre-formulation & Analytical Development
Our perspective is that the comprehensive evaluation of drug candidates during pre-formulation is critical to the formulation development process. Therefore, every formulation project starts with a strategic formulation plan and a dedicated project team. Your drug candidate’s formulation strategy is developed from a thorough analysis of the preformulation data, the intended dosage form options, the expected manufacturing process, known issues, and the strategic goals of your company.
Product Formulation & Clinical Manufacturing
At CoreRx, we know each formulation is unique, just as each drug candidate is unique. Certain candidates present specific challenges such as low bioavailability, poor solubility and/or permeability and instability. Anticipating potential issues prior to initiating formulation development activities can be helpful in overcoming many of these challenges. Our experience allows us to address issues before they become problems.
Certified Clinical Facilities
Our facilities in Clearwater, Florida are FDA and Florida Department of Health registered, DEA approved (Schedules II – V of controlled drugs.) Renovations have been completed to include 13 new Class clean rooms. Our facility is fully cGMP compliant and has an excellent inspection record. Take a virtual tour or in-person to learn more about our capabilities.
Core Technical Services
CoreRx provides quality scientific solutions in all areas of cGMP pharmaceutical development as outlined below.
CoreRx supports contract drug development for the following:
- Solid Oral (tablets, multi-layered tablets, ODT; capsules, multi-particulate drug delivery)
- API/Drug substance in capsules/bottles
- Semi-solids (creams, ointments, lotions, gels)
- Liquids (oral liquids, injectables, suspensions, ophthalmics)
CoreRx Can Help
At CoreRx, our goal is to act as an extension of your team and in partnership, effectively develop your candidate for clinical trials, and ultimately, commercial distribution. In product development, it all comes down to the right people, their development experience and commitment. We are just the partner that can consistently deliver, project after project, building trust with our customers. Trust is the foundation of any successful relationship.
Come, visit our facility, and meet with our team, judge for yourself. Contact us today or call (727) 259-6950.