Our Experts for your Quality Management

Versatile – Composed – Solution-oriented

Your QM Fire Brigade:

Precaution & safety in every case

Keeping the Quality Management System (QMS) of a pharmaceutical company up-to-date and functional is often a major challenge. However, we see it as a unique opportunity to have an overview of the processes in a company, to avoid predictable errors and thus ultimately to maintain product safety. The DREHM QM department therefore stands for lived Quality Management.

Our team has a lot of experience, complemented by many special qualifications, excellent network and the right portion of composure. This gives all our customers the clear results they need – even when trouble shooting is necessary.

In order to avoid problems at all, we are happy to support you on a broader basis by sharing our know-how with you, incorporating it into your QM system, and supporting you where it is most important to you. From the GAP analysis to the provision of a complete company structure.

From trouble shooters to the complete all-round package, we are here for you…

  1. for individual QM projects 
  2. for the permanent take-over of specific tasks or functions
  3. for the provision of a complete corporate structure

DREHM QM Basics – Our Key Areas

QMS / tailor-made Quality Management Systems, especially for small businesses.

We create, optimize and maintain your Quality Management System, specifically for your company.

Procurement, transport and storage of pharmaceuticals are processes that must be carried out and documented correctly. We support you in creating or updating the appropriate system for this – for the ongoing documentation, the correct integration of external partners, as well as for handling deviations.

It is easy to say that a QMS is actually being lived. However, this can only be verified by a thorough Self-Inspection. A missing signature or a wrongly ticked box, it is sometimes the small things that can lead to big questions during an inspection by the authorities or an audit by contractors. From our experience, we know how important a Self-Inspection is to detect and correct precisely such small things in time before they reach critical consequences.

Stressful days before Inspection appointments do not have to be – with timely and comprehensive preparation, stumbling blocks can be identified and corrected. We support you in this process – and would like to explain to you our point of view: to consider an Inspection as a recommendation and suggestion for improvement by the authority.

With GAP-Analyses, we investigate the gaps in your QMS and help you to close them.

Is the new drug making headlines due to fatal side effects, or is the fire caused by a short circuit destroying almost all documents? Even if few companies find themselves in such extreme situations, it is reassuring to have appropriate contingency plans at hand and to know what steps to take. We support you in finding a solution for every emergency situation.

Environmental Management, Health Protection and Occupational Safety are important to us – if you have any questions about these topics, you are just right with us.

Our Heart Beats for Quality. 

We cover the requirements of Quality Management Systems for pharmaceuticals in all areas:

  1. Initiate Product Recalls and Mock Recalls
  2. Identify and Avoid Quality Defects
  3. Planning and Implementing Supplier Qualifications
  4. Establish Quality Agreements
  5. Carry out Eligibility Checks
  6. Handling Movement Notifications
  7. Create Change Proposals (Change Management)
  8. Document and Avoid Deviations
  9. Install Complaint Management
  10. Planning and Carrying out Risk Analysis
  11. Notification of Restrictions on Distribution
  12. FMD Alert Management 

DREHM QM Specials – Our Special Areas

In addition to the competent coverage of all basic Quality Management Requirements, our team has developed special expertise in three areas:

We make sure your pharmaceutical is practically available to patients after approval – from Wholesale Supply to Reimbursement. For the best possible launch, we support you in Analysing the Market, Identifying the Relevant Stakeholders and Preparing the Scientific Data.

On this basis, we develop the Pricing & Reimbursement Strategy together with you. If desired, we will also take over the Operational Reimbursement Procedure for you, including Application, Submission and Follow-up. For original products as well as generics.

The implementation of the Falsification Directive ensures greater safety for patients. The authenticity of a medicinal product packaging is determined by the assignment of a GTIN (Global Trade Item Number) or NTIN (National Trade Item Number) incl. expiration date, batch and serial number guaranteed.

We support you in implementing and complying with the requirements in your company, such as the correct use of the GS1 Application Identifier or the consideration of different country requirements in the coding. If you place pharmaceuticals on the market in several countries, we will also support you in collaborating with the respective national organisation, the so-called National Medicines Verification Organisation (NMVO), for the Data Storage and Retrieval System. For a smooth operation, we also support you in all aspects of Alert Management – dealing with alerts.

Medical Devices may only be placed on the market in the EU if the requirements of the relevant regulation (MDR, IVDR) are met. Do you need a “Fitness Check” for your Medical Device? Assistance with filing Manufacturer Incident Reports (MIRs) or support with Post-Market Surveillance? By working with us, you can be sure that you are in control of all aspects of a distributor in accordance with the law.

“Sharing The Experience” is the motto of DREHM. And you as a customer benefit in particular.

We are happy to share the broad know-how of our team, complemented by extensive expertise from countless projects, and in a variety of ways: through Explicit Training Courses or Lectures, through connection to our E-Learning System, through Specific Reports or Instructions for you. 

We share our local knowledge about the Legal Framework and Contact Persons as well as the Foreseeable Trends with you. Do you need support with Contract Management? Here, too, we are happy to be your professional support.

How We Work

The DREHM QM Team stands for calm solutions and clarity. In this way, we accompany you competently through the Quality Management Jungle.

  • Composure
  • Solution-Orientation
  • Clear Statements
  • Versatility
  • Reliability
  • Charm