OPPORTUNITIES

Market Access

Developing a world best-in-class product is one thing. Successfully launching it on the global market is another!

Two areas that can help shorten time-to-market are effective Regulatory Affairs management and NPI tech-transfer.

When it comes to gaining market access, technology transfer can be vertical (transferring technology relating to a new product from R&D/small-volume production to full-scale manufacturing) or horizontal (transferring an established production set-up to a new geographic location to facilitate market entry).

In both cases, success depends on being able to unify and manage a multifunctional team, including R&D, production and processes, QA/QC, regulatory affairs, marketing and sales, suppliers and distributors, materials and purchasing, and project management.

However, the success of your product depends on more than innovation, production and sales. It also depends on your ability to effectively manage the changing regulatory landscape.

Integrating regulatory activities from an early stage helps to shorten time to market, ensures a smoother process, and maintains market presence.

Market_access

Insights & stories to share

The regulatory world is constantly changing. Don’t be dispirited if you’re finding it difficult to keep pace. You’re not alone.

Implementing a regulatory process harmonized with your product’s lifecycle demands a thorough understanding of the regulatory framework, efficient project and time planning, and effective management of regulatory documentation.

It’s an area that requires both specialist skills and dedicated resources. The most effective route to regulatory approval is to ensure your regulatory process is integrated throughout product development, from idea and development, to product realization, market launch and geographic market expansion.

Key steps include establishing regulatory strategies, conducting gap analyses, evaluating clinical data and labeling requirements, and supporting regulatory assessment, and submissions.

The ability to adapt your processes and establish good communications between your company and the authorities can also be decisive factors for achieving faster market introduction.

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 »

New product introductions are particularly challenging for start-up and small research-intensive companies.

As one of our customers found out, it requires a major change in company culture as well as operations to go from an innovation-based biotech organization to being a product manufacturing organization.

The company was already manually producing an in vitro diagnostic kit on a small scale. The plan was to invest in personnel, equipment and facilities in order to enable larger scale, automated production and launch the product globally.

While the main requirements were well defined, a number of other, subtler challenges had been overlooked. The interdependence of activities, lack of risk assessment, various functions unprepared for their role in tech-transfer, and a prevailing research-focused culture combined to threatened the success of the project.

With the help of workshops with key individuals, PlantVision was able to help the company identify and control the critical success factors; what was in place, what wasn’t in place, what needed to be done. A detailed project plan was drawn up taking into account the interdependency of activities.

This approach made it possible to save both time and costs by identifying those activities that weren’t needed, as well as those that could be combined into a single action or carried out simultaneously. The result:

  • Product approval and market launch as per time plan
  • Better project control
  • Clearly defined roles, responsibilities and deliverables
  • Reduced risk of adverse events and delays
  • New working methods and line organization anchored, accepted and embraced by entire company
  • Corrected workflow deficiencies and new structure for simplifying future tech-transfer projects

LEARN MORE: Find out more about value-driven change »

National and regional authorities all have their own sets of rules and regulations.

When you’re looking to enter new geographic markets this can lead to a plethora of technical document variations – generating added levels of complexity and confusion.

With a clearer understanding about different regulatory requirements it is possible to streamline your technical documentation in order to simplify submissions and regulatory reviews and audits.

By taking a wider scope, you can identify global requirements and build technical documentation that can be easily adapted for specific markets.

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

SPEAK TO AN EXPERT

Cecilia Fällman
Business Area Manager, Regulatory Affairs
Tel: +46 (0) 8 568 595 03
Email: cecilia.fallman@plantvision.se
Connect: LinkedIn »
Thomas Eriksson
Business Area Manager, Business Consulting
Tel: +46 (0) 8 503 045 65
Email: thomas.eriksson@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