CMC requirements for Pharmaceuticals
Chemistry, Manufacturing, and Control is the information required to characterise the:
- Drug Substance (API) for identification, quality, purity, and strength.
- Drug Formulation with an analysis of those components intended to appear in the formulation and those which may not appear, but which are used in the manufacturing process e.g. excipients, raw materials, solvents and the API itself.
- The stability of the Drug Formulation and packaging to ensure that it remains compliant during the period of use.
- All analysis being performed using validated analytical methodology that complies with regulatory guidelines.
This is done to ensure the correct dosage is delivered, in the correct formulation to ensure patient safety and the best outcome for the patient.
To ensure that your product meets the Regulators Requirements Source Bioscience’s, MHRA approved (cGMP), contract research laboratory provides the chemistry, manufacturing and control (CMC) services for all phases of drug development.
We have a proven track record to work in partnership with Pharmaceutical companies providing pharmaceutical testing services that are not core to their business, releasing people and management time to add value to the pharmaceutical drug development process.
Head of Sales – Analytical Chemistry
For further information and prices please contact us or call +44(0) 115 973 9012