EXTON, PA – Frontage Laboratories, Inc. is pleased to announce the approval to expand the scope of its US Drug Enforcement Agency (DEA) license to include formulation development and manufacture of GMP clinical trial materials (CTM). As a result, pharmaceutical companies developing products for the growing pain therapeutics market can rely on Frontage for comprehensive controlled-substance product development support services.
As a full service contract research organization, Frontage has been supporting companies developing DEA Schedules I – V controlled substances for several years. Frontage provided analytical development and GMP analytical testing, clinical trial services and bioanalytical support of clinical and preclinical samples. In order to receive the expanded DEA license to conduct formulation development and GMP clinical trial material manufacturing, Frontage upgraded its facilities, security and personnel procedures at both of its Exton, Pennsylvania sites.
Frontage offers a full spectrum of integrated services to help companies effectively develop their pain management products. These services range from product development and clinical trial materials manufacturing, to clinical research testing, PK/PD evaluation, culminating in final reports that can be provided in Common Technical Document format for FDA submission and approval.
Leading pain management companies have already selected Frontage for the coordination and execution of clinical studies at its clinical facilities in Hackensack, NJ, and bioanalytical PK sample analysis in the Exton, PA, labs. Clients have also tasked Frontage with formulation development and analytical efforts and GMP stability storage for their product development programs. These coordinated services offer clients efficiencies in project management of their drug development programs and have translated into time and cost efficiencies for their projects.
Frontage’s experiences in pain therapeutics range from conducting abuse deterrence studies (both clinically and analytically) and product development for several different classes of pain relievers, including opioid compounds, non-steroidal anti-inflammatory compounds and anti-convulsant medications used as pain treatments. Please contact Frontage’s business development team to obtain further background on specific pain product experiences. Frontage is uniquely positioned to be the flexible and responsive CRO partner of choice for biotech and pharma companies seeking development services for pain therapeutics.
About Frontage
Frontage Laboratories, Inc. is a global contract research, development and manufacturing organization, offering a full range of pharmaceutical R&D services. Frontage operates in the US and China, using one seamless GXP platform. Frontage operates four Phase I clinical research centers: an 88-bed unit in Hackensack, NJ; a 50-bed site in Zhengzhou, Henan Province China; 80 beds in Changchun, Jilin Province and 50 beds in Nanjing, Jiangsu Province, China. Frontage has an AAALAC certified Drug Metabolism and Pharmacokinetic facility in Pennsylvania, where it also maintains leading edge bioanalytical laboratories with 35 of the most advanced LC/MS-MS instruments and separate CMC drug development and manufacturing facilities. In Shanghai and Beijing, China, the company also operates bioanalytical and CMC facilities. As a rapidly expanding CRO with 11 years of successful GXP service offerings, Frontage has established an international standard in pharmaceutical product research, development, quality and management systems. Frontage Labs global sites have been successfully audited by the US FDA close to 20 times, including the first FDA inspection to combine clinical and bioanalytical activities in China.
CONTACT:
Azhar Kalim
Executive Director, Sales and Business Development
akalim@frontagelab.com
Matt Harrington
Manager, Marketing & Communications
Frontage Laboratories, Inc.
484.348.4772
mharrington@frontagelab.com
Matt Harrington, MBA; Manager, Marketing and Communications
Frontage Laboratories, Inc., 700 Pennsylvania Drive, Exton, PA 19341
p: 484.348.4772, c: 610.724.7301 | Sign up to receive Frontage News
