Life Science

With specialist expertise in Life Science, we support companies in Skåne and the surrounding area in both strategic and operational matters. We provide support in complex issues that arise in the business, as well as when launching new products and implementing new technology.

Our experience in Life Science encompasses medical technology, pharmaceuticals and biotechnology. Over the years, we and our consultants have worked with everything from early-stage development companies to global pharmaceutical groups.

WHAT WE DO

LIFE SCIENCE

MEDICAL DEVICES

Our strength lies in the fact that we have
long experience.

Our strength lies in the fact that we have long and broad practical experience from the medical technology industry and can relate to the challenges of both our customers and employees.

We have done it ourselves and can therefore offer sustainable and situation-specific solutions.

Helping companies and entrepreneurs bring innovative medical devices to market and untangle regulatory knots is something our hearts beat for. All medical devices are regulated by different medical device regulations and choosing and understanding what applies to a specific product can sometimes be complicated and time-consuming. With long and broad practical experience from the medical device industry, we can find pragmatic solutions and ways forward in most situations, with a level and scope adapted to the product and company.

We support our clients in finding solutions and strategies, relieve high workloads or unforeseen events and can also help with recruitment. We can act as a sounding board, help develop plans, create a strategy or conduct a gap or impact analysis. Some examples of roles and/or tasks that we can take on are:

Interim assignment/consultant in medical technology
Project manager/scoreboard
Regulatory strategy
QA/RA in operations or in product development projects
Building or improving quality management systems (ISO 13485)
Verification / Qualification and Test Management
Product classification
CE marking (MDR/IVDR)
FDA applications (US QSR)
Processes and strategies for medical software development
Technical documentation
Risk Management (ISO 14971)
Usability/Human Factors Engineering (IEC 62366-1, FDA HFE guidelines)

LIFE SCIENCE

PHARMA

We work with questions, tasks and challenges connected to our customers' daily operations.

Pharmaceutical manufacturing places high demands on safety, quality and efficacy. We can help from process to implementation to ensure product and process quality in order to ensure product traceability and process repeatability.

Manufacturing pharmaceuticals places high demands on safety, quality and efficacy. We can help from process to implementation to ensure product and process quality in order to ensure product traceability and process repeatability. Our consultants are experienced in working with GMP and GDP to meet the requirements for the development, manufacturing and control of pharmaceuticals.

We can take on different roles and/or take care of specific tasks related to:

Quality Management
Quality Assurance
Quality Control
Laboratory work – process, method development, testing and analysis
Internal inspections
Process and Production – qualification and validation
Project management
Procurement and purchasing
Consulting and technical expertise
Interim assignment/consultant in pharmaceuticals

CE MARKING AND REGULATORY COMPLIANCE

The need for the right support for CE marking is increasing as regulations and requirements in medical technology become more stringent. Our CE marking consultants help companies navigate the regulations according to MDR and IVDR, from classification and documentation to technical file and contact with notified bodies.

We offer assistance with CE marking for both new products and existing portfolios that need to be updated according to current regulations. The work includes risk management, clinical evaluation, quality management systems and regulatory strategy.

FDA COMPLIANCE AND FDA APPLICATION

In addition to European regulations, we also support businesses operating in the US market, with advice on FDA requirements and regulatory processes. Is your business facing an FDA application? Do not hesitate to contact us.