OPPORTUNITIES

Quality & Regulatory Expertise

Quality runs at the heart of all life science operations.

Effective quality systems are needed to ensure product safety, support GxP guidelines, comply with regulations and facilitate regulatory inspections.

But in today’s globally competitive marketplace, that is only the starting point.

Quality-operations are also expected to support wider business goals by helping to improve efficiency and flexibility, reduce costs and shorten time to market.

This requires the development of clear strategies based on a risk-management approach that optimize the use of available resources.

The same proactive approach is needed for conducting regulatory affairs. Establishing smart, forward-thinking strategies and implementing efficient yet adaptable processes is the key to maximizing market opportunities.

 

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Insights & stories to share

The right quality partner doesn’t just deliver QA services. They help you to develop and implement effective and lasting quality management systems according to applicable standards, guidelines and regulatory requirements.

They can also help to plan, direct and perform risk assessments and GAP-analyses within complex environments, for example, integrated IT, LIMS and automation solutions.

By organizing workloads and ensuring resources are allocated where they are most needed, you can reduce your costs, minimize risk, and improve overall quality.

These capabilities come from many years of experience working with a wide variety of quality assurance projects. For example, developing validation strategies and performing testing and validation activities across a wide range of areas, including automated and computerized systems (MES, LIMS, DCS, SCADA, IS/IT), laboratory equipment, process equipment, and administrative systems.

The right quality partner will always deliver added value, whether it relates to advice about the impact of new regulations, an internal systems audit, a supplier assessment, or developing a complete quality management system for a new production facility.

  • Improve quality levels
  • Reduce quality-related costs
  • Minimize risk of non-compliance
  • Shorten validation and qualification lead times
  • Support wider process improvement initiatives
  • Strengthen internal knowledge and training

LEARN MORE: Find out more about our Quality Management services »
 
Find out more about training opportunities and scheduled courses »

No two companies share exactly the same approach to carrying out regulatory affairs. However, what unites them all is the need to strengthen RA capabilities at certain times. This is due to the irregular nature of product development cycles and the continually changing regulatory landscape.

For some, it means adding expertise at a strategic level to plan new regulatory processes. For others, it may just mean extra support for carrying out specific projects, such as medical product classification or amending labeling and promotional material.

Your RA partner should be able to help you increase the value of your RA activities, as well as keeping you ahead of new requirements and expected future changes to the regulatory framework.

To do this requires navigating within a global context – helping you to look beyond traditional markets, such as the EU and USA, and take advantage of new opportunities in emerging markets.

Regulatory_process

Regulatory processes should be continually adapted to meet the requirements of a constantly changing regulatory landscape.

LEARN MORE: Find out more by contacting our RA Team »

LEARN MORE: Find Regulatory Affairs training opportunities »

The medical device industry is heading towards major regulatory changes within the EU.

Two new regulations are under development and will soon come into effect, covering medical devices and in vitro diagnostic products.

Remaining compliant requires working proactively in order to identify, prepare and implement the required changes in a timely manner. This is something we can support you with – at whatever level you need.

We also offer customized training sessions and scheduled courses, which can help your organization stay up to date with the latest regulatory requirements, including European legislation, FDA requirements and ISO 13485 requirements.

LEARN MORE: Find out more by contacting our RA Team »

LEARN MORE: Find Regulatory Affairs training opportunities »

SPEAK TO AN EXPERT

Anna-Lena Mann
Business Area Manager, Quality Management
Tel: +46 (0) 8 503 045 82
Email: anna-lena.mann@plantvision.se
Connect: LinkedIn »
Viveka Wretman
Business Area Manager, Regulatory Affairs
Tel: +46 (0) 8 568 595 04
Email: viveka.wretman@plantvision.se
Connect: LinkedIn »

SMART MANUFACTURING

Combining digitization, process integration and the role of individuals.

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OPERATIONAL INTELLIGENCE

Drive continuous improvement by empowering employees.

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QUALITY & REGULATORY EXPERTISE

Experience and expertise ensure compliance with added value.

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MANAGING CHANGE

Value-driven change propelled by insight and project excellence.

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PROCESS ENGINEERING

Design and implement effective production processes using an agile approach.

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SMART LAB

Combine automation, business processes and good information practice.

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PRODUCT SECURITY

Ensure data integrity and serialization projects deliver business value.

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MARKET ACCESS

Effective tech-transfer and regulatory expertise reduce time-to-market.

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About PlantVision

PlantVision is Scandinavia’s leading consultancy for realizing operational improvement.

We offer an integrated approach, broad experience across industries, and in depth solutions expertise. Since starting in 1999, we have delivered value in thousands of projects across Scandinavia and around the world.

We support customers at every stage with professional services and a sound quality approach – from idea, analysis and planning, to implementation, training and long-term support. We also offer the market’s most complete range of close-to-production information solutions.

PlantVision is the ideal partner for companies that want to generate maximum sustainable value from business change.

www.plantvision.se