Quality assurance solutions

Quality assurance solutions

Quality assurance solutions for pharma and biotech

KLIFO provides quality assurance solutions for pharma and biotech companies, combining strategic consulting with operational execution across all GxP areas. Our senior QA specialists ensure that your project not only meets regulatory requirements but also achieves its development milestones without unnecessary delays or risks.

Talk to an expert
Contact our consultants
Klifo, Glostrup. 07/10-2025

Why quality assurance is critical in pharma and biotech

Ensuring quality and compliance at every stage of drug development is a critical challenge for biotech and pharma companies. Clinical milestones, regulatory approval, and patient safety all depend on strong quality assurance systems.

From preclinical studies to pivotal trials, inspection readiness and compliance are essential to avoid delays, regulatory findings, and loss of project value.

KLIFO delivers pharma quality assurance solutions that secure milestones, reduce risks, and keep your project moving forward with confidence.

Contact us
Klifo, Glostrup. 07/10-2025

What pharma quality assurance really means

In simple terms, quality assurance in pharma is about making sure that every partner, process, and deliverable in your development project lives up to the required standards. It covers oversight of suppliers, auditing of GxP practices, qualification of systems, and the design of a quality management system that can stand up to regulatory audits and inspections.


At KLIFO, we see QA not as a box-ticking exercise, but as a strategic enabler. Done right, it protects your timelines, safeguards your investment, and builds the foundation for regulatory approval.

Key challenges our clients face

We often see biotech and pharma companies encounter the same pitfalls when quality assurance is left without expert oversight:
– Missed milestones because a GxP partner did not deliver correctly or on time
– Regulatory audits uncovering compliance gaps or fragmented QMS structures
– Lack of inspection readiness, leaving teams unprepared for authority visits and mock inspections
– Limited in-house capacity to manage suppliers across GMP, GCP, GLP, GDP and GVP
– Resource waste caused by duplicate processes or unclear responsibilities

These issues often arise in preclinical and early clinical phases, where smaller biotech companies outsource most activities to external partners. Without expert QA oversight, projects can lose both time and value.
In one real-world case, our QA specialists stepped in during a critical biologics manufacturing phase. By implementing supplier oversight and addressing incidents immediately, we secured the timely release of the investigational medicine and protected the client’s development timeline.

Typical deliverables

Depending on your development phase and needs, our QA solutions may include:

Vendor and site audits across all GxP areas

Supplier oversight and collaboration management

Establishment and maintenance of a Quality Management System (QMS)

Qualified Person audits of GMP suppliers

GCP, GLP and GVP audit reports

QP declarations for import into the EU and QP certification of Investigational Medicinal Products (IMPs)

Release of investigational medicine for Clinical Trial Supply

Tailor-made training in quality assurance and regulatory compliance

QA counselling and long-term strategic support

Guidance through every phase

CMC activities don’t exist in isolation — they affect every stage, from preclinical planning to commercial supply.


Use the map to explore how our CMC expertise connects with each development phase, and how KLIFO supports you all the way to approval and beyond.

Partner with KLIFO

KLIFO has supported biotech and pharma companies across Europe for more than 25 years. Our clients range from early-stage start-ups to medium-sized pharma, and what they value most is our ability to combine specialist knowledge with operational impact.


If you need a partner who can both advise, execute and design a QA strategy that works in practice, KLIFO is ready to help.


Get in touch today to discuss how our pharma quality assurance solutions can safeguard your development project.

Let’s talk