Sharp Services is an FDA-registered and inspected GMP lab. A standout in pharmaceutical product development, with a focus on transforming APIs into fully formulated and tested products for clinical trials. Our innovative approach ensures swift progress in this crucial stage.Additionally, Sharp leads the way in pharmaceutical packaging, clinical trial supply services, and small-scale sterile manufacturing. With over 70 years of industry expertise, we are dedicated to delivering excellence in every aspect of our operations.
Our quality credentialsGMPUS Food and Drug Administration (FDA) registered and inspectedUS Drug Enforcement Agency (DEA) registered and inspectedEuropean Medicines Agency (EMA) approvedBrazilian National Health Surveillance Agency (ANVISA) approvedUK Medicines and Healthcare Products Regulatory Agency (MHRA) approvedRussian The State Institute of Drugs and Good Practices (FSI SIDGP) approvedTurkish Medicine and Medical Devices Authority (TITCK) approvedAustralian Therapeutic Goods Administration (TGA) approved
Quality and ComplianceWe support pharmaceutical and biotech companies in the reliable, secure delivery of life-saving and life-sustaining drugs to their patients.Quality is our highest priority. As industry leaders, it is built into everything we do and is an area of continuous focus and investment. For our clients, we provide solution-driven, appropriately engineered and skillfully tailored regulatory approaches. Our experts think creatively and work within regulatory guidelines, to deliver practical, compliant solutions. Our team has deep expertise and broad experience in dealing with global regulatory authorities and consulting clients, from large pharma to virtual start-ups.Quality Management System (QMS)Our full suite QMS, QualityOne, helps ensure we operate to a consistently high and harmonized standard to meet the needs of a global market. Implemented across our global network of GMP facilities, QualityOne unifies our approach, strengthens compliance and decision-making and enables us to provide enhanced document management, electronic change control capability, corrective and preventive action (CAPA) and deviation management.Quality CultureEvery member of our team is committed to delivering impeccable standards and results.We have developed programs to certify staff in quality principles and created numerous dedicated roles within our organization.Ongoing training is in place for all our associates. Specific to their job and functional areas, our training programs ensure associates are well versed in all aspects of quality, its importance and how all our people contribute to quality assurance.Robust processesAll starting materials are checked by trained quality control personnel at incoming against specifications to ensure quality and any deficient lots are quarantined.Testing on packaged products is performed by certified teams and the results are documented in the batch record and reviewed by our quality department prior to release.