Pharmaceutical manufacturing authorisation holders are required by law to implement and maintain a Pharmaceutical Quality System. The Pharmaceutical Quality System must incorporate Good Manufacturing Practice (GMP) and Quality Assurance.
QualiPharm Consultancy can provide your company with contract Quality Assurance services to assist your Quality Management System, ranging from design and implementation of a new Quality System for start-up companies to routine management and operation of an established Quality System, including quality auditing to EU GMP.
The role of the Qualified Person (QP) is a legal requirement to ensure that medicinal products are fit for use and certified prior to release to the market or for use in a clinical trial. QP certified products comply with the requirements of EU GMP and the marketing authorisation or clinical trial application.
QualiPharm Consultancy can provide your company with contract QP services, ranging from regulatory advice for importation of medicinal products to final QP certification of marketed products or investigational medicinal products.