Durapharm BV
Durable and sustainable pharmaceutical support

Durapharm BV is your first stop shop for support within the Pharmaceutical Industry and healthcare establishments.

Our focus is not to just give support but to push your process to a higher level; apply in depth GMP knowledge combined with Lean Six Sigma approaches; improve processes where possible and necessary.

Durapharm provides you with expertise in Quality Assurance, Pharmaceutical Manufacturing, Large Projects and Lean Six Sigma (Blackbelt).

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Support is often required in situations where either insufficient hands are available to perform the work or insufficient knowledge is available. Often it is even a combination of both.

In such a situation you want someone with loads of experience willing to roll up his sleeves and to ensure value for your money. You want not only the high assurance of success, but also its accomplishment. The ultimate goal is achievement of a sustainable state of control, when required by changing existing systems and ways of working.

Durapharm BV can support you in but not limited to;

  • Compliance improvements

    For instance improvement of quality systems, deviation reduction, CAPA effectiveness

  • Operational excellence

    Operational excellence without the risk of impacting compliance and including LSS training of Employees

  • Management support

    Management support ranging from hands on management up to setting of new organization structures, KPI’s, visual management, standardized work approaches

  • Projects

    Projects ranging from the startup of a new facility up to small projects

  • Root cause investigations

    For instance recall related investigations, audit observations or ongoing quality defects, low yields

  • QA/QP support

    For instance Deviation control, Change control, Audits, Batch review and release, CAPA closure

  • Audits

    Internal audits (pre-inspection audits) and external audits

Next to the above mentioned support a network is available in order to supply team approaches.
Areas for support are for instance Regulatory Affairs, Validation and all GMP related activities.






Durapharm was founded by Michiel van Raalte in 2013

Michiel has a M.Sc. Pharm. degree (Rijksuniversiteit Groningen), is certified and qualified as a Qualified Person (QP), and is a certified and qualified as Blackbelt for industry (University of Amsterdam).

Prior to starting up Durapharm Michiel worked within the pharmaceutical industry at Organon NV, Schering-Plough and MSD.



He occupied the following positions prior to the startup of Durapharm;

  • Production director of sterile manufacturing unit (120 employees)
  • Project manager responsible for the validation and start up of a sterile manufacturing site
  • Production director of sterile manufacturing unit in Ireland (120 employees)
  • QP Ireland
  • QP and manager of Product Inspection Department in the Netherlands
  • Regulatory Affairs scientist


Durapharm activities 2013-2015:

  • Operational excellence manager (more than one year)
  • Quality Expert within manufacturing
  • QC manager
  • QA support
  • Advisory rolls (manufacturing and quality investigations)