Your one-stop-shop for Production

Proactive- Empathic – Reliable

There for you – in the whole process

We support you from product developement to the batch certification

Regardless of whether you are looking for external support to complement your team, or would rather hand over your agendas altogether: we are your companions. As experts in GMP and GDP, we are able to advise and support you in complying with applicable regulations and standards.

Our team has extensive theoretical and practical experience – from analytics to production to logistics. We have the interfaces in mind just as much as the necessary prioritisation of all processes.

Our key areas

Batch certification is an important part of pharmaceutical Quality Management and ensures that each batch of a pharmaceutical meets the same high-quality standards. DREHM Pharma holds an operating licence (Betriebsbewilligung) and a GMP certificate (limited to office).

We support you by:

  • Advice on the preparation of batch protocols and quality documents
  • Monitoring of the manufacturing process
  • Coordination of imports, batch inspections and tests
  • Review of documentation and records based on legal requirements
  • Execution of EU batch certification by Qualified Persons

You need qualified persons permanently or temporarily to perform legally required functions? Our employees have the necessary training and experience to carry out the following functions for you, such as:

  • Qualified Person / QP
  • Competent Person / Expert
  • Production manager
  • Control laboratory manager
  • Managing director

Compliance with GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) regulations is regularly checked by official audits. Do you need a basic quality management structure to make your company permanently audit-fit? Do you have specific questions about audits & inspections? Or are you looking for professionals to prepare and accompany an inspection? With us you are at the right place.

Qualifications and validations are necessary and required as a basis for the consistent quality of your production processes. We competently and pragmatically take over the qualification of your devices and validation of your processes (warehouse, transport, production, including the associated software).

We can also assist you in setting up a corresponding Quality Management system for your production or carry out operational tasks directly in your systems, including document management.

You learn with us

“Sharing the experience” is the DREHM motto – and that of course applies to our production clients as well.

We share with you

  • our theoretical knowledge
  • and our practical experience

How? Either hands on as part of our joint projects or through topic-specific training for you and your team.

How we work

From theory to practice. We are professionals in the necessary details, and we have the big picture in mind: We take over the process lead, take care of the project management and the necessary interfaces, and prioritize correctly.

  • Proactive
  • Flexible
  • Uncomplicated
  • Patient
  • Empathic
  • Experienced
  • Reliable

Production topics are technical

We solve them humanly

You think your duties are the only ones that are relevant? Of course! And we treat it the same way. You will receive our full attention, prompt responses and tailor-made solutions.

Regardless of whether you have sophisticated questions or are new to the subject and unsure what to do: we are at your side with empathy and patience. And think around the corner to find solutions even in complicated cases. 

We look forward to assisting you with your pharmaceutical manufacturing needs and helping you comply with applicable regulations and standards.

You are still in despair and couldn’t find the solution to your problem? Don’t worry – just ask us! Together we will find a way.