ServicesBusiness Consulting Services

Our promise: Impact and Speed!

The markets are challenging: faster product cycles, increasing pressure to innovate and heavily increasing regulatory requirements. Our team of business experts offer end-to-end support along all regulatory fields. More than 500 experts are ready to help and move your business to the next level.

Business Consulting in regulated industries

We are focused on a common goal: the successful management of a wide range of tasks related to regulatory affairs, clinical trials, quality management, R&D, production, and IT. With our vast experience, profound knowledge, and a variety of resources, we help companies master the current market challenges. Faster product cycles, increasing pressure to innovate, complex digitalization and increasing regulatory requirements. With our expertise from thousands of projects and a high demand for speed and quality, we support you in your individual business inquiries.


Regulatory Affairs

The range of services and knowledge in the field of “Regulatory Affairs” is broad and touches on a multitude of different directives, laws, regulations and standards. At the same time, internationalization leads to a variety of country-specific regulations with explicit differences in approval.

The core areas in this area are adaptations to the products as well as their labeling and testing prior to market launch. The creation and maintenance of technical documentation must comply with the requirements of the Medical Device Regulation (MDR) or the German Medicines Act (AMG) as well as the respective differences in international approvals. In addition to the FDA, the CFDA and PMDA must increasingly be taken into account here.

Our experts are experieced in:

  • Risk analysis of the approval process taking into account all regulatory and normative requirements
  • Creation and design of all information and forms relevant to the approval process
  • Technical documentation
  • Know-How in all regulatory requirements (AMG, MPG, MDR, MDD, AIMDD, MEDDEV, AMWHV, ISO 13485, ISO 14971, ISO 14155, ISO 20416, IEC 62366, IEC 62304)
  • Support of certification processes
Clinical Affairs

Clinical Affairs deals with questions relating to the clinical application of a medical device or pharmaceutical product. The aim of the activities is to prove that the products actually provide the clinical benefit in practical use that is set against the risk in risk management. The clinical benefit of the product must be supported by data and monitored and confirmed throughout the product life cycle.


The MDR and the AMG tighten the requirements for clinical evaluations. We offer the customer immediate expert support.

  • Development of a Clinical Study Protocol (CSP)
  • Creation of standard operating procedures (SOP) for uniform project implementation and preparation of study documents (protocol, eCRFs, patient information, investigator folders).
  • Study design and recruitment of study participants
  • Global study execution and monitoring (documentation, execution, follow-up, local regulation)
Quality Management

Medical devices and pharmaceuticals are subject to strict quality assurance requirements. This applies both to certification and approval procedures and to quality management of production and processes. In principle, both pharmaceuticals and medical devices must meet specific performance and safety requirements. Quality management monitors the entire production cycle - starting with the supply of materials through to product delivery. Central to this is that the product should meet customer requirements, production targets and regulatory and normative requirements. The tasks link closely with regulatory, manufacturing and R&D activities.

The refinement of quality management - and the focus on new topics and innovations is typically a process in which expertise is brought in from outside. With our staffingsolutions, we help to solve resource bottlenecks to the point.

  • Planning, implementation, maintenance and further development of the quality management system according to EN ISO 13485, IVDD/ IVDR, FDA 21 CFR 820.100
  • Supervision of conformity assessment procedures and approval procedures in European countries
  • Execution and implementation of the CAPA process (Corrective and Preventive Action) along the standards ISO 13485, 21 CFR 820
  • Creation, maintenance, management and updating of Q documents (VAs, AAs, SOPs, technical documentation)
On average, companies from the medical technology & pharmaceutical environment invest around nine percent of their sales in research and development. The progress made by both industries in recent decades has been tremendous. Regulated industries are under enormous cost pressure which has a direct impact on research budgets and the speed of R&D implementation. At the same time, the pressure on innovation is increasing at the same rate.
  • CIP / development processes (Six Sigma, Lean) and Development of technical design documents (ISO 13485, 21 CFR 820)
  • Technical analysis of products, product applications and manufacturing processes
  • Process and test method validation
  • Construction planning / product development / design & documentation of manufacturing and testing concepts
  • Patent monitoring

The MedTech sector as well as the pharmaceutical industry, which are dominated by medium-sized companies, have only limited resources for developing and implementing new manufacturing processes. Therefore it is important to involve production experts at an early stage.  And also to increasingly rely on innovation partnerships and distributed production strategies with specialized partners.

Our experts suport you in several areas including
  • Analysis and definition of the production process (PFMEA/FMEA, creation of manufacturing documents and process tools)
  • Design planning
  • Support in the preparation of documents relevant for admission
  • Auditing and optimization of the procurement process for subcomponents
  • Planning of the assembly process / production optimization (Industrial Engineering)
  • Lean Management, CIP, Six Sigma

In order to further advance digitalization, interconnectivity and automation, the use of Artificial Intelligence, robotics as well as Machine Learning is of extraordinary importance. However, due to the creation and utilization of a large amount of data, cyber security is also playing an increasingly important role. Particularly in sectors such as medical technology and the pharmaceutical industry, where work is carried out with highly sensitive data, the protection of patient safety is a top priority, which is why the demand for IT experts in the field of cyber & network security is increasing dramatically on an international level.

  • Implementation of IT compliance audits according to ISO 27001
  • Creation and consulting in the life cycle of systems and solutions of relevant MES, LIMS, RIM, PV, CTMS as well as QM system providers
  • Cyber & Network Security
  • Integration of AI & Machine Learning Solutions
  • Cloud / DevOps / IT Test Automation
  • Data Engineering & Analytics

lexoro Facts

We offer our clients short-term support and extensive expertise in project peaks. Our network – your chance.

More than 500 consulting
Projects delivered
Business-Process-Expertise in
all regulated areas of
MedTech, Pharma & Chemicals
More than 350 Associated-
Business-Experts in 6 fields
of service
Knowledge Services for
client organization – free of
24 h
24-hours expert availability
for urgent project peaks
Best-Practice tools to
speed up project delivery
by up to 30%

Are you looking for experts at short notice?

Our Solution: lexoro 24 hour expert sourcing

lexoro experts

We accelerate your projects by accompanying them with our expert support (individuals or teams).

We deliberately keep 25% of our expert competence free and available to constantly react to exciting new use cases, customers, and project challenges.

lexoro associated experts

lexoro supports demanding projects on a temporary basis with 530 top experts – competent in the medtech, pharma & chemical industries.

We guarantee professional excellence and verified project references.

Arrange a consultation now

Your contact person

Sven Kolthof

Managing Director

You are considering our business services for your current or upcoming projects?

Our contact persons for project and network inquiries are available at all times to answer any questions you may have about the market and our range of services. We look forward to hearing from you.

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