We drive your projects to success in highly regulated industries.
Problem solving
Does this sound familiar?
We know these situations. We have solved them hundreds of times. In highly regulated industries, where every mistake gets expensive.
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Projects stalling?
Our most important project has been passed from desk to desk for months, and nobody really owns it. External consultants deliver slides, not execution.
We take over project leadership
Accountability unclear?
Everyone is responsible. Or no one. Meetings produce meetings, but no decisions.
We put structures in place
Product transfer
We need to relocate production. New plant, new suppliers, same product, same approval. In what order?
We bring in our transfer methodology
Regulatory affairs
EU MDR, FDA 510(k), IQ/OQ/PQ, MDSAP. The approval clock is ticking, and we need someone who is not doing this for the first time.
We steer regulated projects through to approval
Capacity
We are short an experienced project manager for six months. But we do not want to add headcount. We need expertise, not a hire.
We provide capacity
Knowledge leaves, knowledge is missing
Our PM knowledge lives in heads, not in documents. If the wrong person leaves, half the project leaves with them.
We secure knowledge
What we offer
We solve both, the structural problem and the technical problem
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Projects stall because nobody truly steers them.
PM-Service
Operational project delivery
We take over operational project leadership: entire project teams, PMO support, program steering, risk management and reporting. Execution instead of slides.
Learn morePM methodology and project reality do not match: no shared vocabulary, unsuitable processes.
PM-Consulting
Tailored project consulting
We build up PM processes, tools and methods. Traditional, agile or hybrid: IPMA®, PMI®, Scrum™, SAFe® Agilist, Hybrid+ for the reality in between. Coaching included.
Learn moreYou need specialized expertise for a project, but not another permanent hire?
PM-Recruiting
Capacity exactly when you need it
Our network of experienced project managers and subject matter experts, deployed flexibly. Freelance specialists from MedTech, pharma, automotive and aerospace. Quickly on board, matched to your project.
Learn moreProduct transfer, new product development, PMI, regulatory approval. All at the same time, of course.
Engineering & Regulatory
Design, validation, approval
Design engineering, process engineering, validation (IQ/OQ/PQ), regulatory support. CAD, cleanroom, testing, quality engineering, technical documentation. All under one roof.
Learn moreAs a project or program leader you make decisions every day that you can rarely discuss openly within your organization.
PM-Sparring
Leadership needs a counterpart
Looking for an experienced counterpart instead of hands-on involvement in your project? Get yourself a decision sparring partner. With our coaching for project leaders, you gain a confidential and independent outside perspective.
Learn moreNot sure where to start?
Which WIC service fits your challenge?
The WIC Navigator will show you.
Answers in seconds. Describe your situation. The WIC Navigator checks whether and how WIC can support you.
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You know where your project is stuck, but not whether WIC is the right partner for it? Describe your situation in your own words, whether it is a product transfer, a bottleneck in the team, a regulatory hurdle or missing structure. The WIC Navigator assesses your request and shows you whether and which WIC services fit, from PM-Consulting and PM-Service to PM-Recruiting and Engineering. Not a ready-made solution, but clear initial guidance on where WIC can help.
PM-Service
Operational project ownership.
We take over project leadership or build a PMO, including all sub-services.
- Provision of entire project teams
- Project and program steering
- PMO support & tracking
- Design, procurement, process engineering
PM-Consulting
Tailored project consulting.
We develop and implement processes, methods and tools. Traditional, agile, hybrid.
- PM, PMO and multi-project methodology
- Process optimization within projects
- Coaching & workshop facilitation
- IPMA® · PMI® · Scrum™ · SAFe®
PM-Recruiting
Capacity exactly when you need it
Access to our network of experienced freelance project managers and subject matter experts. No long-term commitments.
- Specialists matched to project requirements
- Available globally
- Fast onboarding
Engineering
Design & process engineering.
From initial concept to production drawing, including procurement and data maintenance.
- 3D/2D CAD, assemblies
- Process engineering, validation
- Cleanroom, quality engineering
- PLM/ERP data maintenance
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Success stories
When clients bring us into their projects
And what happens when we leave.
Product transfer of a MedTech product incl. sterilization and packaging.
Relocation of an entire production: new suppliers onboarded, sterilization process designed, temperature-controlled transport chain established. Quality and functionality secured.
Building the organizational structure in software development.
Kanban introduced, regular synchronization established, end-to-end process optimized. Coordinated software releases have run smoothly ever since, with measurably more effective use of resources.
Introduction of company-wide project and portfolio management.
Standardized PM process, templates, portfolio steering, training for all project managers. Faster lead times, clear prioritization, measurably more efficient delivery.
Not every problem is a technical problem. Often, structure is simply missing. Structures do not solve technical questions. We solve both.
To me, project management is like a bouquet. Only when all the elements come together does something complete emerge, something that works.
05
When mistakes get expensive
Project management in highly regulated industries
Project management as the steering link for successful projects in highly regulated industries
In highly regulated industries such as MedTech, pharma, aerospace or automotive, requirements, risks and costs are high. Product lifecycle and technical guardrails have to fit together seamlessly. From development through regulatory affairs and quality to documentation. What slows projects down is rarely a technical problem, but pending decisions, missing execution and unclear priorities. This is exactly where project management comes in: as the link that brings all disciplines together and steers them. Only when everything interlocks does the whole thing work.
Product lifecycle
New product development
Product transfer
Product Sustaining Engineering
Project management
the link that connects and steers
Technical guardrails
Product development
Process development
Regulatory affairs
Quality
Technical documentationIndustry focus
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How we work
We don't just talk. We deliver.
Part of your team
We integrate into your structures and standards. No foreign body, no parallel shadow organization.
Hands-on, not slideware
The challenge rarely lies in the "how", but in the execution. So we execute, from plan to completion.
Fast, global, flexible
A worldwide network of freelance specialists. We scale the team with your project, up during peaks and back down as soon as demand drops.
Highly regulated is our home turf
MedTech, pharma, aerospace, GMP and GCP. We know EU MDR, FDA 510(k), MDSAP, IQ/OQ/PQ. We know which details matter, and when.
Snacksize Podcast
Snack-sized knowledge that moves you forward.
A look behind the scenes of Wisst International Consulting. In short, compact episodes we take you into the world of project management and share insights from our projects.
In Snacksize we take you into the world of project management. In short, compact episodes we share insights from our projects so you can make your own more efficient and more successful. Plus tips and methods that have proven themselves with us over the years. Great guests included.
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We share our knowledge
Project management knowledge.
Free, structured, up to date.
We share our experience from 15 years of project management. For you, that means templates, checklists, field reports and perspectives on current regulatory topics. No paywall. No lead form in front of every article.
Discover our free top downloads! Templates for your day-to-day PM work.
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Culture
We take care of projects. And of the people who carry them.
WICARE is our in-house program for health, mentoring and personal development. Good project work starts with people who have the energy for it. Project success does not come from methods alone, but from people who genuinely like the company they work for.
Training budget
Mentoring formats
Flexible work models
Team Events & Community
Mental & physical health
Current job openings at WIC
NEXT STEP
Tell us about your project
in a few sentences.
Email is the fastest way to reach us. We will get back to you within 24 hours with an initial assessment and available times for a no-obligation conversation. Talk directly to one of our experts. Book a no-obligation call. Together we will look at your project and show you exactly where WIC can lighten the load: structure, standards, supply chain.