Clinical Trial Support
Oakmontscript has evolved over the years, and become very knowledgeable about the methods and procedures that must be followed during the procurement and delivery of essential comparator drugs and/or reference standards, all designated as Reference listed Drugs (RLD) per US FDA orange book and Reference Product (RP) per US FDA purple book. Our experiences in preparing and shipping clinical trial products can ensure that you always get the highest quality RLD products for your research.
Oakmontscript will always search for new markets and new partnerships to expand its business scope. After having entered a major agreement with Mckesson to support clinical trials and new drug development, Oakmontscript has developed partnership with Tanner Group, Myoderm, companies that have also seen a lot of growth in commercialization of comparator drugs and the market share of clinical trials supply.
We make RLD products accessible to businesses, researchers and patients worldwide.
As a DEA certified exporter and distributor, Oakmontscript has met all legal requirements of local, state and federal laws and regulations. With established direct access to US FDA approved drugs, devices, OTC, vaccines, plasma, biologics, Oakmontscript has put compliance first and foremost in its business operations and its frontline customer services. In fact, we are a leader in regulatory compliance of CS and Drug Supply Chain Security Act (DSCSA).
Oakmontscript has extensive knowledge about what your expectations are when it comes to RLD products, and will help optimize your purchase strategy thereof. As a leader in clinical trials support, Oakmontscript will help you gain access to virtually any product – even the difficult-to-source items in the most cost-effective way possible. We provide integrated services in many areas including analytical testing of small and large molecules, clinical trial management and industry forecast, over-encapsulation, and clinical trial packaging. In a nutshell, Oakmontscript will create single-source solutions that meet all your needs in clinical trial support.
In order to safeguard brand innovators and their protections of patients’ rights and market right,Our compliance team will make sure：
A. Buyer is engaged in the discovery and development of pharmaceutical products; and their application will go for FDA approval
B. Buyer is registered and duly authorized to purchase and import the medicines specified below, in this contract; and
C. Buyer is properly authorized and licensed to use the medicines in research, testing, and evaluation activities; and
D. Buyer agrees that all purchases from Oakmontscript are for their “own use “as that term is defined in Abbott Labs et al. v. Portland Retail Druggists Assoc. et.al., decided by the U.S. Supreme Court on March 24, 1976;