Our current operation located at our Dulles Virginia Headquarters contains a 5°C Controlled Environment Room that is licensed by the U.S. Department of Justice, Drug Enforcement Administration for the Wholesale Distribution and Export of Schedule 2-5 Pharmaceutical products. In addition we are licensed by the Commonwealth of Virginia Board of Pharmacy for the wholesale and Global Distribution of Schedule 2-6 Pharmaceuticals.

Our business plan was developed by carefully evaluating the requirements of 21 CFR and all of its components for the storage, logistical distribution and compliance criteria. We carefully tailored our management structure and developed a comprehensive set of standard operation procedures following the guidelines set forth in 21 CFR Parts 210-211 cGMP Guidelines for Storage and Handling of Pharmaceutical Products, 21 CFR Parts 820.01-820.25 Quality System Regulations and 21 CFR Part 11. When we were completed with our document control components and the Standard Operating Procedures, we designed and built a state-of-the-art drug vault as described in 21 CFR Section 1301.72 for the storage of schedule 2-5 pharmaceuticals including narcotic products. Upon completion of the Controlled Environment Room (5°C Drug Vault) we contracted Insight Calibration and Validation Services to write a validation protocol which we reviewed and approved and the room was mapped with 48 thermocouple's and the control processes were validated.

Upon certification of the calibration and validation process, we applied with the Commonwealth of Virginia Board of Pharmacy for licenses to warehouse and distribute narcotic and other scheduled pharmaceuticals. The investigators from the Commonwealth of Virginia Board of Pharmacy inspected our facility and performed a preliminary audit for the purpose of evaluating our quality systems and documentation process. After this audit was satisfactorily completed, the team came back to perform an additional facility and security audit and Cavalier was granted our Schedule 2-6 Controlled Substances Wholesale Distributors Licenses # 0220000541. We immediately applied for our Federal D.E.A. schedule 2-5 licenses from the Department of Justice, Drug Enforcement Administration and after passing a document review audit and a facilities audit, we were granted our Controlled Substances Registration Certificate # RD0326632 and Export License # RD0333144.

If you have need for 3PL Services specializing in cold chain management and distribution, please contact us at coldstorage@cavlog.com or e-mail Cliff Wyllie, VP of Bio-Pharma Healthcare Services directly at cwyllie@cavlog.com. We look forward to hearing from you!