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

The next requirement arrives. But who tells you what matters now?

Q: Must we implement every new draft immediately?

A draft is not an already applicable requirement. Whether preparatory work makes sense depends on its status, applicability and your business. We label these differences explicitly rather than deriving a blanket deadline from a draft.

Q: Do you continuously monitor every regulatory change?

This service starts with an agreed subject and business scope. Ongoing monitoring and regular reassessment require a separate, clear engagement. A one-off assessment does not automatically cover later changes.

Q: Do we receive a list or actual implementation?

First, a sound decision is needed on which work is required. We can then take on the agreed documentation and validation packages. Scope, your team’s contributions and completion criteria are defined before starting.

Your QA reads new publications alongside daily operations. The message reaching management is mainly: there is more to do. What actually applies to your business, what is still a draft and which work must come first remains unclear. We turn this uncertainty into concrete decisions and work that can be commissioned.

Arrange your free initial consultation

15 minutes · by phone · free of charge

What it means for your business

An update is not an implementation plan.

A webinar or newsletter can provide orientation. It does not automatically establish which of your processes, systems and evidence are affected. Without that comparison, you either start premature projects or accumulate a backlog that nobody owns.

Budget goes into an unclear need

Without applicability and an assessment of the current state, effort is difficult to approve meaningfully.

Urgent and future work get mixed together

Current requirements, drafts and recommendations need clear labels and different decisions.

The task list grows without completion

“We need to address this” helps your team only when it becomes a concrete deliverable with an owner.

What we deliver

From a regulatory text to prioritised work in your business.

Clarify status and applicability
We assess the named publications against their primary sources. Current requirements, drafts and recommendations are separated and related to the agreed part of your business.
Compare against your current state
With your owners, we assess existing processes, systems and evidence. You see where current work is sufficient and where a specific gap needs to be addressed.
Prioritise and deliver agreed packages
You receive a decision brief with required actions, dependencies and owners. We take on explicitly commissioned implementation packages through to the agreed review stage.

Agreed before we start

When is it finished?

The agreed assessment is complete when sources and status are documented, applicability is justified and prioritised actions are assigned. Evidence and completion criteria are defined separately for commissioned implementation packages.

Clear responsibilities

Your team's contribution

You identify the relevant sites, products, systems and contacts. Your QA confirms the technical assessment and owns quality-system decisions. Management prioritises budget and capacity. We agree the scope; legal advice is not included.

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 →

Less document work. Clearer review.

In traqx, the agreed documentation work is prepared from sources approved for the project. Word drafts, visible changes and review history support delivery. The named owners assess the technical significance of a publication and provide formal approval.

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. The HMS Analytical Software case shows the path from baseline analysis through implementation to training, with processes scaled to company size.

See the project cases →

**Elisabeth Kohm**HMS Analytical Software

Before we speak

Your questions, answered.

Must we implement every new draft immediately?

A draft is not an already applicable requirement. Whether preparatory work makes sense depends on its status, applicability and your business. We label these differences explicitly rather than deriving a blanket deadline from a draft.

Do you continuously monitor every regulatory change?

This service starts with an agreed subject and business scope. Ongoing monitoring and regular reassessment require a separate, clear engagement. A one-off assessment does not automatically cover later changes.

Do we receive a list or actual implementation?

First, a sound decision is needed on which work is required. We can then take on the agreed documentation and validation packages. Scope, your team’s contributions and completion criteria are defined before starting.

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.