Compliance work is piling up?
We get your projects across the finish line.

For life-science SMEs with fewer than 500 employees: we take on your GxP compliance projects when everything depends on one or two key people. With a clear result, deadline and fixed price for the agreed scope.

Successfully delivered in over 60 projects in pharma, biotech, laboratories and contract manufacturing.

Top expertise Wholeheartedly recommended by clients

Project experience · Memberships

What clients value about our work.

All client stories →

Processes that fit. Expertise when it matters. A team that works together.

Elisabeth Kohm
Elisabeth Kohm Head of Quality Management and Quality Assurance HMS Analytical Software
Software & analytics company GxP environment Mid-sized business

Processes that fit the company.

Assignment
The work at a software and analytics company spanned baseline analysis, implementation and staff training.
Approach
DH Consulting combined project management and effort estimation with implementation. Processes were adapted to the company’s specific characteristics.
Result
Processes fit the company, and staff are trained. Every task, from baseline analysis to implementation, was completed competently and on time.

Your team needs processes that work day to day and fit the size of your company. We implement them with your staff and train the people who use them.

Read client feedback →
Andreas Etges
Andreas Etges Business Project Leader Boehringer Ingelheim
Pharma corporation Project support

Expertise for regulated projects.

Result
Highly regulated projects moved forward successfully, supported by specialist expertise and outstanding work from DH Consulting.

Your project needs to move forward, but your team has no time to tackle demanding specialist questions. We bring the expertise and help with the implementation.

Read client feedback →
Patryk Rutkowski
Patryk Rutkowski Tollgate Review Lead Novartis
Pharma corporation Global ERP project

One team in a global ERP project.

Result
Individuals became a successful team that worked together and supported each other, even under tight deadlines in a global ERP project.

Several people are involved, deadlines are tight, and coordination keeps landing on your desk. We take on project leadership and give your team a shared direction.

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Where is your compliance work getting stuck?

A small team carries the responsibility. Every absence, audit and new requirement competes for the same hours. We start with the issue that puts the most pressure on your business.

Everything rests on one or two people.

When someone is absent, approvals stall. The quality position remains vacant, the team is at its limit and the project deadline approaches.

We take on a clearly scoped work package. Result, deadline and fixed price are agreed. We document knowledge and train deputies with your team.

Relieve your team →

Every audit disrupts daily operations.

Your best people spend weeks gathering documents. Daily work falls behind. A customer audit may also put the next contract on the line.

We close the agreed evidence gaps, organise the documents and rehearse retrieval with your team before the audit.

Prepare for your audit →

Documentation consumes expert time.

The same information is copied into several files. Versions go back and forth by email. And when someone asks, it is unclear which version applies.

With traqx, we prepare drafts from your approved sources. Your experts review content and changes in Word. Sources, responsibilities and open points remain traceable.

Get evidence under control →

More requirements. The same team.

Your head of quality flags another change. What needs doing now, what can wait and how is the team supposed to manage this too?

We turn the technical assessment into a work plan: act now, schedule or monitor. With effort, ownership and the next step.

Prioritise requirements →

IVE: you know who delivers what and when.

IVE stands for Integrated Validation Execution. Our method connects project leadership with hands-on delivery: one shared plan for your team and us, from the agreed result to handover.

Built on 17+ years of practice and 30,000+ hours of project work.

  1. Agree the result before we start.

    Scope, milestones, fixed price and completion criteria are agreed. You know what you will receive and how completion will be demonstrated.

  2. We take responsibility for delivery.

    Every task has an owner. We carry out the agreed documentation and evidence work. Your team contributes operational knowledge and makes the technical decisions.

  3. You see progress and receive the handover.

    You receive a clear project status at an agreed rhythm. We document open points, reviews and handover. Your quality process governs formal approval.

The six building blocks of IVE

  • Clear onboarding
  • Clear project scope
  • Clear responsibilities
  • Clear reporting
  • Clear monitoring
  • Measurable KPIs

Your experts should make decisions.
Not spend their day assembling documents.

We combine hands-on delivery, the IVE method and traqx as a shared workspace. We prepare and review documents together, so your experts can focus on the decisions that need their experience.

Less searching. Less retyping. Clearer reviews.

Start from your existing knowledge
Your approved sources and templates form the basis for drafts. Experienced staff do not have to explain every detail again.
Review changes in context
Word documents carry tracked changes and source comments. Review status and the history of decisions stay visible.
Make the work easier to hand over
We document the work with your team and train the people who will continue it. Your existing quality process governs formal approval.
An example of our working process
Our team + IVE + traqx From task to reviewed document
  1. Your starting point

    Your sources, templates and a clearly scoped task.

    Your team + us
  2. A draft you can review

    A Word version with tracked changes, sources and visible open points.

    Us + traqx
  3. The expert decision

    Review the content, resolve questions and prepare the document for your approval process.

    Your experts + us
A traceable document. Ready for your quality process.

We assess the benefit against your actual work: time spent creating and reviewing documents, outstanding questions and completed deliverables. Your QMS and specialist systems retain their existing roles.

Discuss your bottleneck →

traqx is a product of the independent traqx GmbH, co-founded by Daniel Herrmann. Workspace setup and onboarding are part of our project planning. Ongoing use after the project is agreed separately.

Daniel Herrmann

Corporate experience. For your mid-sized business.

Daniel Herrmann has validated computerised systems in the life-science industry for 17+ years, from mid-sized companies to corporate programmes at Boehringer Ingelheim.

Your best people should move your business forward. We take on the delivery and organise the work with your team so that knowledge can be shared and projects can finish.

Daniel HerrmannFounder, Daniel Herrmann Consulting

The team behind the delivery

  • Dr. Philipp Cavelius Dr. Philipp Cavelius
  • Jacqueline Schmitt Jacqueline Schmitt
  • Caroline Herrmann Caroline Herrmann
  • Tina Gosewinkel Tina Gosewinkel
  • Annette Mumber Annette Mumber
  • Selina Wolter Selina Wolter
60+validated systems
17+years of practice
100 %audit pass rate
0critical findings

Is your project a fit for us?

You lead a life-science company in the DACH region with fewer than 500 employees and decide on budgets and priorities as a managing director or authorised signatory.

Our focus is on pharmaceutical companies and CDMOs where a small number of experts carry compliance. For biotech, MedTech and laboratories, we assess technical fit against your specific project.

When a different approach is more suitable

We are usually not the right partner for companies outside the GxP world, subsidiaries without their own budget authority or pure staff provision. We tell you openly in the initial consultation.

Planning an enterprise rollout or S/4HANA migration? To SAP validation →

This is how we start

  1. 15 minutes by phone

    Your situation, a few targeted questions and an honest assessment of whether a strategy session makes sense. Free of charge and without obligation.

  2. 90-minute strategy session

    We assess your most pressing compliance issues with everyone involved in the decision and propose one fitting approach. Feel free to bring your head of quality.

  3. Implementation, if it fits

    A clearly scoped project under IVE: agreed result, responsibilities, deadline and fixed price.

What you may want to know before you book

What happens in the free initial consultation?

15 minutes by phone: your situation, your most pressing topics, our honest assessment of whether a strategy session makes sense. You will not be sold anything, promised.

Why do you offer it free of charge?

Because in 15 minutes we hear whether we can help, and you hear whether we fit you. If both are yes, the strategy session is worthwhile for both sides. If one is no, we have both invested only a quarter of an hour.

Do I need to prepare?

No. It helps if you have your two or three most pressing topics in mind. Nothing more is needed.

What does a collaboration cost?

Every engagement has a fixed price for a clearly defined scope: a starter package, projects in fixed-price stages, cancellable ongoing support. We name the concrete range in the strategy session, as soon as the scope is clear. The initial consultation is free of charge.

Are we too small for you?

We work for life-science SMEs with fewer than 500 employees. What matters is your project, available expertise and decision authority. Even a small quality team can start with a clearly scoped work package.

We belong to a group or a corporation.

If your parent company decides on budgets, we are usually not the right partner. Approach us through your group management.

We already have a QP or a QM consultant.

Good: we do not replace named roles. We deliver completed states and work together with your existing service providers, not against them.

The next step takes 15 minutes.

Click the button, choose a phone slot, and we talk briefly and honestly about your situation. Free of charge, and it commits you to nothing more.

Arrange your free initial consultation

15 minutes · by phone · no pitch