Product care from an experienced hand

We would be pleased to accom­pany your medi­c­inal prod­ucts from the product idea through the approval process to quality and life­cycle manage­ment including all analyt­ical tasks. Expe­ri­enced and prac­tice-oriented, in an advi­sory and exec­u­tive capacity.

The spec­trum of our services is always oriented towards the specific concerns and require­ments of our customers.

On behalf we take responsibility:

  • Regu­la­tory Affairs Services / Registrations
  • Devel­op­ment and main­te­nance of QM systems (GMP, GDP)
  • Phar­ma­covig­i­lance
  • Clin­ical & medical assessment
  • Drug / batch release as a service (soon)
  • Audits (incl. API) & inspections
  • Quality control & stability testing
  • Release test and EU retest (coming soon)

We take over respon­sible roles:

  • Regulatory Affairs

    We competently and reliably equip your pharmaceutical and healthcare products with all regulatory requirements for successful and rapid market access.

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    Regulatory Affairs
  • Quality Management

    We support the establishment and optimisation of your QM systems and everything that goes with them in a responsible and experienced manner.

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  • Clinical & Medical Affairs

    We prepare meaningful clinical and medical reports and documentation for the scientifically substantiated assessment of your products.

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    Clinical Affairs TentaConsult
  • Vigilance & Surveillance

    We take responsibility for the safety monitoring and risk assessment of your products at every stage of their life cycle.

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    Vigilance - Surveillance TentaConsult
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