There are many Contract Research Organizations (CROs) out there from small single-purpose specialty firms to large multi-national conglomerates. Whether you have a new biopharmaceutical product that needs proof-of-concept work, or need method validation for your product release testing, they can help. With that being said, choosing the right CRO is critical to the success of your projects but there are so many options that evaluating them is challenging.
DISCOVER THE NUCRO-TECHNICS ADVANTAGE
As a CRO, Nucro-Technics is very unique and this goes back to its founding in 1970. We have had the opportunity to grow and evolve with the pharmaceutical industry. Although there are facilities out there that may specialize in one particular aspect of an organization’s drug development programs, most do not offer the same breadth of experience and expertise that you will find at Nucro-Technics, Canada’s largest privately-held CRO. For services involving chemistry, microbiology, toxicology, bioanalytical, genetic toxicology, and RA/QA consulting, we are a single-site facility and all work is done on our premises with nothing being outsourced. This allows for easier communication and greater control of service quality.
A CRO that Communicates
At the end of the day, the success or failure of a project will depend on the communications that take place between the client and the CRO. At Nucro-Technics, clients have a single point of contact for any pre-clinical, clinical, and market authorization work that is conducted. Because there is so much trust that is being placed in us, we are happy to have clients come on-site to see where the work will be happening. Having a single-site operation also makes troubleshooting any issues found at the research and development phase happens more easily. Test article chain of custody is easier to determine, and any information transfers between functional departmental project teams (such as a transfer of samples from toxicology to bioanalytical) happens more transparently.
GLP & GMP Compliance
Nucro-Technics is compliant to both GLP and GMP regulations. The Standards Council of Canada will audit our facilities for compliance to the OECD GLP regulations while Health Canada and the FDA will audit our facilities to GMP standards. This is exceptionally rare – Most CROs will focus on one aspect or the other.
Although these regulations have some similarities, they are applied differently. Studies conducted to GLP standards are typically used as part of an IND package. Studies conducted to GMP standards are used to support a product registration.
Because both GLP and GMP studies are conducted at our site, this means that Nucro-Technics can support new molecular entities from the benchtop all the way to the bedside. Method development and method validation both at the pre-clinical and product release phase can happen at the same facility.
A Dedicated & Experienced Staff
When partnering with Nucro-Technics, we effectively become an extension of your organization. You get an on-demand team of experts at your disposal which include toxicologists, veterinarians, chemists, microbiologists, genetic toxicologists, and biochemists. What we ultimately do is apply the talents of the people that work at our organization to the challenges that our partners bring us. Nucro-Technics staff have more than 4,000 years of combined experience in their respective disciplines and have experience with both small molecule and large molecule compounds across a wide-array of therapeutic indications.
A Long History of Success & Compliance
Operating since 1970 in the highly competitive pharmaceutical industry is no accident. It requires dedication to quality and to the needs of our customers. Throughout our history we have completed hundreds of IND packages, developed and validated thousands of methods, and completed hundreds of thousands of projects.
Not only does Nucro-Technics routinely complete projects for the biggest pharmaceutical, biotech, and medical device companies, but we do extensive work with smaller organizations just starting their IND product development, industry trade groups, and academia.