About Us
At
Coldstream Laboratories Inc., we're seasoned at turning pharmaceutical
development ideas into safe, pure, and effective clinical pharmaceutical dosage
forms. Since 1986, we have completed more than 200 formulation development projects that led to clinical trials providing us extensive clinical
manufacturing experience with both commercial product development and
grant-funded projects from such sources as the National Institutes of Health.
We are registered with the FDA and the Commonwealth of Kentucky Board of
Pharmacy for the clinical manufacturing of pharmaceutical products. Our work
represents a wide range of formulations, testing, and production for a broad
spectrum of clients.
Our current manufacturing capabilities include semi-solids,
solutions, suspensions, and lyophilized powder dosage forms. Coldstream
Laboratories Inc. has a full-capabilities analytical laboratory with
proven method validation experience yielding the most accurate results
possible. Our Formulation Development Unit has experience with a wide range of drug
substances and excipients. Our Quality Systems organization operates under
a quality manual, a validation master plan, and standard
operating procedures that comply with the FDA's cGMP Regulations. Our
Quality group is also responsible for approval of final product Certificates of
Analysis.
Our senior management has more than 100 years of pharmaceutical
industry experience in preformulation, analytical, and formulation
development, as well as Phase I to Phase III clinical and commercial
manufacturing.
Our goals are to:
-
Deliver a high quality product to our customers.
-
Be available, flexible, and carry out projects in a timely manner.
-
Provide high-quality, cost-efficient services.
-
Respect our customer’s intellectual assets by maintaining a high level of confidentiality.
We welcome visits to our facilities in Lexington, Kentucky to conduct audits or to meet with our scientists. Contact us at customerservice@coldstreamlabs.com or 859-257-6600 to let us help you turn your research into reality.
Coldstream Laboratories
Inc.
1500 Bull Lea Road, Suite 250
Lexington, KY 40511
Phone: (859) 257-6600
Fax: (859) 323-5985