SOURCE: bioRASI

bioRASI

February 18, 2009 14:40 ET

bioRASI to Exhibit at the GPhA 2009 Annual Meeting Business Exposition in Naples, Florida

A Leading CRO in ANDA and 505(b)(2) Programs to Showcase Its Full Service Capabilities

HOLLYWOOD, FL--(Marketwire - February 18, 2009) - bioRASI, a full service, global Contract Research Organization (CRO), announced today that they will participate in the GPhA 2009 Annual Business Exposition in Naples, FL on Feb. 23rd - 25th. bioRASI will be exhibiting at booth # 2 and will showcase its full service capabilities for optimizing drug development programs for ANDA and 505(b)(2) NDA FDA submissions.

"bioRASI's focus on the ANDA and 505(b)(2) markets has allowed us to perfect our program optimization capabilities," said Dr. Boris Reznik, Chairman of bioRASI. "We have been broadening our worldwide clinical research base which allows us to be very selective in our choices of PIs and clinics in order to uphold the highest quality while saving our clients time and money."

As a global CRO, bioRASI provides a full range of services required by ANDA and 505(b)(2) NDA applications, including program management, regulatory strategy design and implementation, clinical development, analytical lab services, Part 11 compliant data management, data analysis and report writing.

bioRASI is particularly strong in therapeutic equivalence and dermal safety studies where it has leveraged its unique global access to strong PIs and special patient populations to optimize programs in dermatology, ophthalmology, and GI. Additionally, utilizing bioRASI's Phase I clinics and bioanalytical laboratories, bioRASI has a rich history of completing difficult to recruit and difficult to perform PK, BE and BA studies.

"bioRASI has become a leader in clinical endpoint and therapeutic equivalence studies. We are also arguably the world's leading CRO in dermal programs, including transdermals," said Gary W. Thompson, bioRASI's Vice President of Business Development. "Our strong presence throughout the Americas, Europe and India allows us to implement the most time and cost efficient strategies and solutions, while increasing the quality of the results."

About bioRASI

bioRASI is a Full Service Global CRO that collaborates with the leading biotech and pharmaceutical companies in the clinical development of novel and generic therapeutics. Specializing in ANDA and 505(b)(2) NDA programs, bioRASI facilitates obtaining FDA approvals by delivering high quality regulatory and clinical strategies, solutions and services, while saving their clients critical time. bioRASI services include program management, regulatory, clinical, data management and analysis, compliance and audit. bioRASI leverages its access to world renowned researchers and facilities in the U.S., Europe and Asia, to achieve unparalleled scientific, clinical and business results at significantly lower costs. bioRASI is headquartered in Hollywood, FL and has regional offices, labs, and clinics across the globe.

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