Industry · Pharma, Biotech & Life Science

Client consultancy for pharma, biotech & life science

With MI Support as your advisor, you get an experienced partner on your pharma, biotech or life science project. We take responsibility for ensuring GMP, cleanrooms, qualification and validation are designed into the project from the start.

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Pharma and biotech construction requires specialists

When GMP, cleanrooms and regulatory requirements define the project

In pharma and biotech, it isn't enough for the building to be completed – it must also be qualifiable for pharmaceutical production. Cleanrooms, ventilation, cleaning systems, material selection, flow and documentation must all meet strict regulatory requirements.

With a project manager from MI Support, you get a partner who understands both construction and regulation and takes responsibility for ensuring the two worlds meet in time.

Our consultants have worked with pharma and biotech projects in Denmark and abroad for many years. Our strength lies in connecting the construction site, the bioprocess and the quality organisation, so the project ends up coherent both technically and from a regulatory perspective.

When GMP, cleanrooms and regulatory requirements define the project

Our expertise

Specialised knowledge of pharma construction

GMP, FDA & pharmaceutical standards

We know the requirements of GMP and FDA and ensure the construction meets all regulatory standards from the very first groundbreaking.

Cleanrooms & controlled environments

Experience building sterile production environments with precise ventilation, pressure conditions and materials that safeguard the cleanliness of products and people.

Biological production

We coordinate construction for the production of biological medicines, vaccines and therapies with a focus on cell technology, cleaning systems and traceability.

Qualification, validation & IQ/OQ/PQ

We ensure all facilities and systems are thoroughly tested and documented through IQ, OQ and PQ, so they are ready for approval and operation.

Risk management & quality

We coordinate tests, approvals and documentation in all phases of the construction, so quality is safeguarded all the way.

Production facilities & laboratories

Experience with everything from raw material production and filling to laboratories and research facilities, where precision and cleanliness are crucial.

Our services for pharma, biotech & life science

This is what we deliver to life science clients

Whether you are facing a new production facility, a conversion of existing cleanrooms or a major shutdown, MI Support's experienced consultants are ready to steer the project to completion together with you.

Client consultancy

Independent advisor throughout the entire pharma construction project, from strategy to commissioning and handover to operations.

Project management

Experienced project managers with pharma experience who steer the project to completion with a focus on GMP, quality and regulatory requirements.

Construction management

Construction managers with an understanding of cleanrooms, GMP and quality requirements during execution.

Scheduling

Integrated master schedules in Primavera P6 and MS Project with commissioning and qualification built into the critical path.

Project economics

Cost control, forecasting and variation management on pharma projects, where scope changes are the rule rather than the exception.

Project assistance

Document management and PMO support for the heavy governance requirements that characterise GMP construction.

Shutdown planning

Planning and management of shutdowns on operating pharma facilities with minimal downtime.

Safety management (HSE)

Safety coordination on pharma sites where production, conversion and new construction often run in parallel.

Facility types

Experience from across the pharma value chain

Our consultants have worked with some of the largest pharma and biotech players in Denmark on both brand-new facilities and expansions of existing ones, so we know the regulatory framework in detail. Whether it concerns API production, sterile fill & finish facilities, biotech and fermentation, vaccine production or advanced laboratory facilities, we can contribute specialised knowledge.

Why MI Support

A partner that understands pharma

Specialised consultants

You get pharma-specialised consultants who know both the construction site and the regulatory world from the inside. We have worked with quality and validation at large pharmaceutical companies and know what it takes to get a facility approved.

Independent client advisor

We exclusively safeguard the client's interests. Without ties to contractors or suppliers, we can hold firm on your priorities and ensure the requirements are taken seriously from the start.

Documentation that holds up

We establish a governance structure and documentation that can match the authorities' requirements and give you peace of mind when the audit approaches.

Shall we help with your pharma project?

Do you have a pharma or biotech project that must be carried out with both engineering and regulation under control? Contact us and we'll have a chat about how we can help.