CMC consulting

Drug development. Pure and simple.Our passion is your success.Improve the success of your drugs.Improvinglives through better drug development. Our Purcision technology is award-nominated. Click here to learn more! Pharmaceutical CDMO Criti Tech’s expertise and partnering approach will help get your project to the finish line. In the world of drug development, companies have a broad range of Contract Development Manufacturing Organizations (CDMOs) to choose from. Customers choose us to be their pharmaceutical CDMO because of our unique particle engineering innovation and expertise as well as our demonstrated experience in delivering high-quality, on-time results. Our passion is to help our customers achieve their product development and manufacturing goals – so they can help improve the lives of people around the world. Our array of services as a contract development and manufacturing.

analytical servicesFill-finishGMP productionmanufacturing process developmentmethod developmentparticle engineeringPurcision supercritical precipitation (SCP)quality assurancespray drying

Drug Discovery Alliances provides a pharmaceutical R&D platform backed by an integrated team of CMC consultants and a global network of preferred suppliers, driving programs from discovery phase to commercialization. Founded in 2001 by Deborah Minor, Ph.D., the company supports biotech and pharmaceutical companies with drug discovery, drug development, CMC consulting, and regulatory support.

analytical method developmentantibody manufacturingAPI manufacturingcatalysis screeningcrystallizationformulation developmentGMP auditingGMP manufacturingIND application preparationmedicinal chemistrypreclinical developmentprocess researchregulatory supportsolid form screening

Kinexum provides regulatory consulting services for life science products, using experience with major agencies worldwide such as FDA, EMA, and MHRA to help clients with regulatory, nonclinical, CMC, and related development and commercialization challenges. Since 2003, Kinexum has supported over 500 companies globally with a team of more than sixty subject matter experts, most holding MDs, PhDs, MBAs, or JDs, based across North America, Europe, and Asia.

CDMO selection and managementclinical supply planning and managementdue diligenceFDA special designationsgap analysisnonclinical study design and monitoringquality assurance and controlregulatory strategy and pathway analysisregulatory submissions (IND, NDA, BLA, IDE, 510(k), de novo, PMA)