Laura Weston
Laura has a broad experience base in the pharmaceutical industry in the areas of CMC regulatory, analytical chemistry, quality control, quality assurance, and formulation development for small molecule and biological pharmaceutical products. Her motivation for high quality results is balanced with strong interpersonal skills. Some of her key accomplishments include:
- Authoring and/or editing the CMC sections of numerous NDAs and one BLA that were all approved within the established PDUFA timeframe. These products include the Zegerid product line (powder for oral suspension, capsules, chewable tablets, and tablets), Uceris, and Ruconest.
- Discovered the root cause of dissolution failures of a commercial product and negotiated requirements for necessary changes with the FDA, which prevented a back-order situation and resulted in several issued patents.
- Pre-Approval Inspection team leader for Zegerid Suspension project, resulting in zero 483 observations at the international drug substance and drug product contract facilities.
Lone Pine CMC Consulting, Inc.