We are experts in analytics, legal compliance, chemistry and engineering. Professional experience  qualifies us in supervision, research & development and quality management/ assurance. Our provided scope of activities is issue, release respectively control of documents, declarations (labelling), raw materials, processing aids, products and/ or packaging materials for active pharmaceutical ingredients (APIs) and bulk pharmaceutical excipients (BPEs).

Please contact us. Your enquiries are welcome!

 info@aro-control.de

For pharmaceuticals we provide these services:

I. Creating technical documents

  • change control documentation
  • GMP documents (forms, standard operating procedures und technical documents)
  • expert reports and statements

II. Management systems training

  • BVW (employee idea system) and KVP (continuous improvement process)
  • optimization of processes GxP (GDP, GLP, GMP …) and HACCP
  • issue of documentation (forms, standard operating procedures and technical documents), knowledge management and document administration (data management driven by e.g. WINDREAM)
  • culture of error tolerance and customer complaint handling
  • preparation and support of audits, inspections and certifications by
    • internal audit team
    • authorities
    • companies and customers

III. Lecturing

  • in-house trainings
  • technical presentations or posters
  • lectureships and acting as substitute for professorships

IV. Coaching

  • implementation of legal compliance with respect to
    • AMG and AMWHV
    • EU-GMP guideline
    • ICH Q7
  • implementation and updating of certificate of suitability and/ or GMP certificate
  • compliance with industry standards of
    • ISO 9001, ISO 14001 and/ or ISO 50001
    • OHSAS 18001
    • compliance with halal and/or kosher requirements
    • single-project management