For managing directors & authorised officers · Life-science SMEs < 500 employees

The role is vacant. The deadline is not.

One or two people hold your compliance work together. Then an audit, a system project or an absence lands on top. Suddenly every open question reaches your desk. We take on clearly defined work packages so your project can move forward.

Arrange your free initial consultation

15 minutes · by phone · free of charge

What it means for your business

You need support that takes work off your team.

Another consultant who needs to be managed by your specialists merely moves the bottleneck. What matters is who produces the documents, tracks the open items and leads the package to its agreed conclusion. We define exactly that scope with you.

Deadlines become a gamble

Project plans assume capacity that day-to-day work has already consumed. The gap often becomes visible only just before the milestone.

Knowledge stays with individuals

Cover works only when status, decisions and next steps can be handed over clearly.

Management becomes the project office

You chase owners and delivery dates instead of running the business.

What we deliver

We take on a package your team cannot finish today.

  1. Clarify the backlog and deadline

    We review tasks, existing documents and available contacts. The result is a defined assignment with priorities and dependencies.

  2. Produce documents and coordinate delivery

    We create the agreed drafts, coordinate technical questions and maintain an open-item list. You see what is complete and which decision is still needed.

  3. Prepare completion and handover

    The result includes the agreed evidence, review status and a handover that enables the named owners to carry on.

Agreed before we start

When is it finished?

The agreed package is complete when the defined documents are available, review items are resolved or explicitly handed over for decision, and your named owners have accepted the handover.

Clear responsibilities

Your team's contribution

You name a subject-matter contact, provide access to the agreed sources and decide priorities. Your QA reviews and approves under your quality system. That formal responsibility remains with you.

Delivery with a method and a workspace

IVE leads the work.
traqx supports delivery.

Our IVE method gives the engagement a clear structure: understand the situation, agree the scope, carry out the work and hand over the result. You know which decisions are needed and what defines completion.

Explore the IVE method →
traqx

Less document work. Clearer review.

In traqx, we prepare Word drafts from the agreed, approved sources. Visible changes, review status and history support handover between author and reviewer. Your team joins at defined review points instead of writing every document from scratch.

Your existing QMS or DMS remains the authoritative system. Formal approvals follow your quality process.

See how we work with traqx →

From project experience

Experience you can assess.

Mid-sized business · Software and analytics in a GxP environment. From baseline analysis through implementation to a trained team: processes scaled to company size.

See the project cases →

From baseline analysis through project management and effort estimation to implementation and staff training, every task was delivered highly competently and on time. Company-specific characteristics were kept in view throughout and the processes scaled accordingly.

Elisabeth KohmHMS Analytical Software

Before we speak

Your questions, answered.

Do you permanently replace a vacant role?
We agree the exact scope and period. This can cover a defined project or a transition phase. You decide whether a permanent position is also needed based on your ongoing responsibilities.
How much time does our team still need to provide?
That depends on the package, source quality and open decisions. Before starting, we identify your required contributions and review points. A lack of internal capacity must not first surface during delivery.
Can you start while we continue recruiting?
If scope, contacts and sources are clear and capacity is available, delivery can run alongside recruitment. We agree the possible start and handover to a new employee before engagement.

For your QA team: explore the technical details

CSV consultingSystem validationAll services

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