What we Do

Our Services

KVALITO​ is exclusively focused on the regulated Life Science and Healthcare market. Each regulated area is clearly defined and carefully selected so that our SMART service is nothing short of impeccable. This is why KVALITO is trusted by global industry leaders who rank in the top 10,  and operate in the field of: Pharmaceuticals, Biotechnology, Medical Software, Medical Device, Radiation-Emitting products, Vaccines, Food, Biologics, Blood, Veterinary and Animal Health, Nutraceuticals and Cosmetics. 

Our Pillars of Excellence

The KVALITO service portfolio is based on Pillars of Excellence that cover all essential areas of a technology-enabled and innovative Life Science organization. According to our SMART quality approach our clients have the choice to select all pillars to get the full service, or to go step by step.

Audit & Assessment

Before deciding where you want to go, we’ll tell you where you’re at.

Audit & Assessment is the entry point into Quality & Compliance. KVALITO experts provide business and maturity assessments to give you a clear understanding of where your business stands today. This is the first step to transform, standardize or simply move your business one step ahead of the competition. With deep  experience in audit and assessment at all levels, our experts propose risk-based and pragmatic action and remediation plans.

Computerized System Validation (CSV) audits: Cloud (SaaS), Machine Learning, Mobile and Digital, AI, Augmented/Virtual Reality, Robotics, Blockchain, Biomedical devices.

Good Manufacturing Practices (GMP) audits: Biologics, Sterile and Cell Therapy-based Manufacturing, Quality Management Systems, Development Centres, Contract Manufacturers and Suppliers, Personalized Medicine.

Smart Quality & Compliance

 Don’t settle when it comes to quality and compliance. Put your SMART foot forward.

​SMART is the KVALITO way of managing Quality and Compliance in the industry.

Using SMART, we build global and local regulatory requirements and industry standards into business processes to build trust with regulators. Organizations enjoy true benefit from this approach as the upshot is low impact to business operations, with maximum output and value.

 

Transformation & Change Management

We’ll help you make the changes you want and the ones you didn’t know you need.

Due to changes in corporate strategy, new technologies, mergers, acquisitions and divestures, businesses change ever more frequently and in more fundamental ways. We help our clients to master their change and transformation with a focus on efficiency, quality, and compliance, to guarantee an effective and secure transition of the organization, and its fundamental assets such as processes, data, and applications. By understanding your underlying risk exposures, we show you how to translate regulatory requirements (GxP, Data Privacy, Security, Integrity, SOX) into management actions with minimal disruption to business operations. 

Strategy & Advice

Get on the Right Track.

We believe that a strategic definition works better when viewed from an outside perspective. For this reason, we at KVALITO, start by collecting your business goals and company specifics so that we can put together a technology strategy based on your Business Strategy. A Technology/Digital Strategy is the enabler for abundant business opportunities and growth. The challenge is to determine the right technology mix and ecosystem. We deliver the optimal digital strategy to achieve cost-effective implementation and operation tailored to your precise needs. Our Strategy Consultants know how to master your challenges to generate solutions founded on SMART quality and compliance. 

Business Process Excellence

The biggest room in the world is the room for improvement!

KVALITO’s holistic service approach identifies business needs, determines solutions to business challenges, mobilizes business opportunities and implements governance frameworks. 

We design and implement Quality Management Systems with definitions of required operational processes, which we build into frameworks based on best practices and applicable regulatory requirements.

Choosing the right ecosystem can be confusing, considering the variety of suppliers and technologies on the market. KVALITO helps you choose the right platform, select the optimal technology, and design the most effective digital strategy to achieve mobile excellence. We turn your digital and mobile landscape into a structured and standardized ecosystem.

Special Expertise

Total Quality Mindset, Be Ready! 

The KVALITO portfolio includes the provision of talented interim Backup Leadership and Management Professionals for regulated industries. We work with talented Business and IT Executives, and Subject Matter Experts who are qualified, trained and prepared for our client needs. Deep functional know-how combined with holistic thinking enables our Experts to focus on our clients’ most pressing challenges and opportunities. We are known to exceed expectations by capturing value across the business;  trimming down costs, whilst revving up efficiency.

 KVALITO Consultants

Our large, highly effective network of professionals are top of the line, offering full spectrum industry expertise to meet our clients’ needs. Our confidence in what we do comes from our expert team, backed by our accessible network of 500+ carefully selected specialised partners with varying skillsets to draw upon.

Bringing out the Best in You

Service Setup

ASSESSMENT AND ACTION

Do you need an expert eye to have a look at your situation and give you some sound advice? We offer professional Consultation in Business, Tech, Compliance and Product Quality. Our service is tailored to your needs, so whether you need help in one area or many, we’ve got you!

Getting Some work Done

Are you looking for a hand as well as some professional advice? With a talented team of industry professionals with varying backgrounds and a network of 500+ consultants and subject matter experts, we are confident we can lend you the hand you need to take you business to the next level!

The WORKS

 Are you looking for the kind of service where you step back whilst the transformation crystallizes? We offer Backup and Project Peak Support for when you really can’t take the load on your own. We offer Interim Management and Leadership Professionals, and act as a Strategic Partner for the Temporary Provision of Business and IT Executives.

In partnership with

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