Diteba.com provides cGMP analytical and GLP bioanalytical testing services
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About Diteba.com
Diteba Research Laboratories Inc. is a licensed contract research organization (CRO) that provides pharmaceutical testing services including cGMP analytical and GLP bioanalytical testing services.
About Us
Diteba Research Laboratories Inc. is a licensed contract research organization (CRO) that provides high quality analytical and bioanalytical research and testing services. Our services are performed in accordance with the requirements of the US Food and Drug Administration, Health Canada, and International Conference on Harmonization (ICH) guidelines.
Our laboratory is licensed by Health Canada as a GMP drug establishment and registered as a Drug Establishment with the U.S. Food and Drug Administration (FDA). We are also licensed by Health Canada to handle controlled drugs and substances.
Diteba was founded in 2003 to deliver personalized, R&D intensive solutions to clients in the pharmaceutical, biotechnology and natural products industries. Diteba's team is comprised of professionals averaging more than 10 years experience in analytical and bioanalytical chemistry. Our team has worked at the world's largest CRO's and pharmaceutical companies and also brings a wealth of knowledge from academia. Our knowledge and experience allows us to perform your analytical and bioanalytical studies in a timely and efficient manner.
Background
Often, pharmaceutical companies avoid new methodologies prefering to stick to established procedures for drug development so as to avoid any potential regulatory ambiguity. This tendency to avoid new methodologies and regulatory scrutiny sometimes leads to slower progress and higher costs. Furthermore, some pharmaceutical firms severely restrict academic research-based modifications to established procedures in drug development because of their concern over triggering costly adjustments to the established regulatory framework.
These structural and organizational inefficiencies have prompted the emergence and growth of contract research organizations (CRO) in the past two decades. However, the growth of larger CRO's into global research and manufacturing companies has led these companies to exhibit the very inefficiencies they were created to eliminate. These inefficiencies, stemming from inflexible structures, complicated and long decision-making processes and a hesitance to become involved with the sponsors, prohibit meaningful, intensive and customized R&D projects.
Dr. Theo Kapanadze, co-founder, identified this weakness in the larger CRO's and aspired to create an environment where the brightest academic ideas could be efficiently integrated into a highly regulated drug development framework. This notion has become increasingly important in the last decade as the industry migrates away from blockbuster drugs that targeted the larger population toward tailored drugs that target smaller segments of the public. So a more flexible and R&D intensive CRO is clearly needed by both emerging and established pharmaceutical companies, which also takes into account recent advancements in genetic research.
In addition to incorporating the latest academic ideas into drug development processes, Dr. Kapanadze also saw the need to embrace the latest advancements in electronic data capture. A comprehensive information infrastructure will guarantee compliance with the requirements that regulators apply towards ‘electronic signature' and ‘electronic audit trail' (e.g. e-lab infrastructure). Such infrastructure is vital for processing large volumes of data, while still preserving flexibility to incorporate changes into non-stop production processes.
Laboratory Services Offered
Diteba provides full-service pharmaceutical laboratory services for: Analytical Testing; Bioanalytical Testing; Stability Storage and Testing; Physical Testing; Cleaning Verification and Validation; Formulation Development Support Testing; and In Vitro Release Rate Studies
Our Laboratory Location
Diteba Research Laboratories Inc. is a private corporation located in a newly built facility in Toronto (Mississauga), Ontario, just minutes away from Toronto International Airport.
Our analytical laboratory occupies 9,000 square feet of fully network-equipped, state-of-the-art laboratory equipment and office space, including a stability storage room with temperature and humidity chambers covering entire ICH recommended range of storage.--Sam Ricchezza 11:15, 16 April 2010 (PDT)
- Laboratories
- Analytical Lab
- Bioanalytical
- Bioanalytical Lab
- Hplc Testing
- Ich Stability
- In Vitro Release Testing
- Contract Research Organization
- Cro
- Laboratory Testing
- Analytical Method Development
- Cleaning Validation
- Chemistry
- Research
- Stability Studies
- Dissolution Testing
- Elisa Testing
- Analytical Solutions
- Bioanalytical Solutions
- Pharmaceutical Testing Service
- Preclinical Testing
- Clinical Testing
- Testing Lab