Large Company QMS Harmonization
LARGE COMPANY QMS HARMONIZATION CASE STUDY CHALLENGE:One of the world’s largest life science companies was experiencing a significant increase in scrutiny from the FDA. At a time when the FDA’s increased expectations of QMS harmonization within large integrated life science companies had increased, multiple audits highlighted the need for harmonization across the company’s groups. The […]
Due Diligence
DUE DILIGENCE CASE STUDY CHALLENGE:A large multi-national pharmaceutical company determined that the best strategy for a major pain-relief product was to expand associated synergistic product offerings. One product was a medical device from a small device company whose device applied a magnetic field with claims to alleviate pain and reduce inflammation. While targeting the device […]
Design Control Document Templates
DESIGN CONTROL DOCUMENT TEMPLATES CASE STUDY CHALLENGE:A medium-sized manufacturer of invasive therapeutic products wanted an improved design control process that could function well with both disposables and systems. APPROACH:AlvaMed developed an approach that made use of detailed, self-tutoring templates for all DHF document types. RESULTS:The templates have been successfully used to provide a thorough and […]
Training
TRAINING AlvaMed’s approach to training sets us apart from competitors. Our training is customized to the client’s needs and delivered by regulatory, quality and clinical consultants. Our trainers are true experts in their fields and each presentation is tailored to the organization and audience. Whether it’s a general training for all your staff or a […]
