AKTEHOM

About AKTEHOM

At the intersection of scientific expertise and regulatory consulting, AKTEHOM supports industrial players in the pharmaceutical and biotechnology sectors in mastering and understanding products and processes with an objective of quality and performance to guarantee patient safety. AKTEHOM has a strong identity, focused on customer relations and the well-being of its employees, which is added to proven expertise. The pleasure of bringing value to our customers, successfully completing their projects, and succeeding together guides our team of 50 people daily. AKTEHOM is involved in the following areas: Product/Process Mastery: implementation of QbD, characterization study, process optimization... Process Validation: risk analysis, control strategy, process validation, process transfer, monitoring Contamination Control: cleaning, decontamination, sterilization processes, extractables and leachables... Quality Systems: risk management, process control, third-party control, data management, data integrity Commissioning and Qualification: equipment, facilities, utilities, VSI... Compliance: regulatory watch and interpretation, compliance assessment, support for responding to injunctions Analytical: validation and transfer of analytical techniques, analytical QbD Men and Organization: training, cultural change, technical and human coaching