Commercialization2018-08-16T16:23:36+00:00

COMMERCIALIZATION

ZebraSci’s Services, Resources, and Facilities support development at any stage in the product life-cycle.

fda approval product launch

Regulatory Submission

As competition and increased regulation drive innovation, collaboration between partnerships in a global environment becomes critical to the success of an approved filing. We provide Senior Management with insights to reduce regulatory risk and remain compliant, while evaluating strategic tasks against proven strategies that can help align the organization’s regulatory strategy and operational strategy allowing for sustainable growth. Whether its emerging regulations, latest industry best practices, or regulatory oversight trends to direct strategy, we help customers operate within the new and existing regulations in ways that protect, enhance, and create value. As a trusted business advisor, we work in partnership with our customers to deliver customized, practical solutions aimed at mitigating current and potential risks to the organization.

Combination Product Development

ZebraSci’s experience in engineering, human factors, and commercialization for auto-injectors, needle safety devices and novel drug-device systems assists organizations in developing combination products from early concept through commercial launch and post-market monitoring.

Effective product development and commercialization is a central driver of business growth. Line extensions and evolutionary development are an important source of revenue and profit to businesses, but the greatest return often comes from revolutionary developments.

It is ZebraSci’s aim to show how all these requirements need to be translated into the development activities across the range of drug – device combination products, including prefilled syringes (PFS), auto-injectors, and needle safety devices.) We provide the expertise to integrate the drug and device aspects of combination product development for clients in the biopharma and pharma sectors.

Risk Assessment

Innovation involves taking risks. There are several techniques and practices that are designed to reduce these risks. ZebraSci aids organizations in choosing the appropriate tools to help them with their risk management activities. We will support the organization in developing the analytical framework for measuring, managing, and monitoring risks. ZebraSci has experience implementing effective risk management programs within small and large organizations, across functions, sites and therapeutic areas, to make risk management a central part of product development.

Risk management is the backbone of effective design control and supports the organizations’ regulatory strategy as well as helps direct the company’s quality planning activities. Risk management is an integral part of producing robust designs within device development and is performed throughout the product life cycle. We aim to institute a risk management process that meets device and drug regulations by integrating ICH Q9 and ISO 14971 and helping organizations understand, evaluate, and take action on the appropriate risks with the view to increase the probability of their success.

Human Factors

ZebraSci’s experience in engineering, human factors, and commercialization for auto-injectors, needle safety devices and novel drug-device systems assists organizations in developing combination products from early concept through commercial launch and post-market monitoring.

Effective product development and commercialization is a central driver of business growth. Line extensions and evolutionary development are an important source of revenue and profit to businesses, but the greatest return often comes from revolutionary developments.

It is ZebraSci’s aim to show how all these requirements need to be translated into the development activities across the range of drug – device combination products, including prefilled syringes (PFS), auto-injectors, and needle safety devices.) We provide the expertise to integrate the drug and device aspects of combination product development for clients in the biopharma and pharma sectors.

Project Management

We transfer the strategies developed for regulatory submission and device technology into operational plans. These plans are developed once we perform an assessment of the organization’s landscape, identify and prioritize gaps, and determine the methods that we will use to execute the strategies.

Product Complaint & Root Cause Investigation

Product Complaint & Root Cause Investigation

YEARS TO INVESTIGATE AND SOLVE

EXISTING COMMERCIALIZATION
& PRODUCT CHALLENGES

  • Commercialization is Expensive
  • Product Quality Issues are Costly
  • Delay to Market
  • Costly Screenings/Sorting
  • Recalls and Product Complaints
ZebraSci Combination Product Services

SOLUTION!

ZEBRASCI

  • Determine process limits and specifications for customers
  • Demonstrate how to apply ZebraSci equipment to solve problems
  • Fully characterize devices and primary packaging
  • Use process expertise to tune processes

RESULTS

  • Swift Root Cause Investigation
  • Effective Design of Experiments Activities
  • Statistical Correlation
  • Effective Corrective Actions
  • Reduced times to commercialize product

RELIABLE PRODUCT LAUNCH DATES