Quality Assurance

InfarAMA has a diversified team of experts offering a wide range of Quality services and support for pharmaceutical companies.

  • Taking responsibility as a contract Responsible Person and/or Qualified Person

  • Batch certification and batch release

  • Auditing services (suppliers, customers, internal)

  • Preparation and support for inspections by competent authorities (FAHMPS, ANSM, IGJ, …)

  • Remediation after inspection

  • cGMP & cGDP compliance and licensing

  • Development and support of quality management systems (redaction and review of SOPs, Quality Agreements…)

  • Quality System improvement

Our dedicated and highly qualified team, is flexible to give support on-site or from the Infarama offices.