Quality Assurance
BioTechLogic Inc. offers hands-on, outsourcing, and/or consulting quality assurance services to domestic and international clients. Our industry experienced team members have developed and implemented quality systems within the biopharmaceutical, pharmaceutical, medical device, and combination product industries.
Our regulatory and quality assurance team members have developed and implemented quality systems in accordance with Current Good Manufacturing Practices (21 CFR 211), Pharmaceutical Development (ICH Q8), Risk Management (ICH Q9), Quality Systems (ICH Q10), Quality System Regulations (21 CFR 820), and EU Good Manufacturing Practices.
We can assist you with organizational activities, plans, policies, procedures, processes, and provide the resources associated with designing, implementing, and maintaining a quality system focused toward meeting customer satisfaction. BioTechLogic Inc. supports our clients' Quality Assurance departments by providing the following services: