Tech Transfer, Scale-Up and NPI

HiTech Health’s cross-functional expertise and dynamic team of consultants can assist with all aspects of the scale-up process to full commercial production. We place a strong emphasis on ensuring product supply is robust, high quality and cost effective.

technical transfer scale up

New Product Introduction

 

HiTech Health has experience with all aspects of product development from pre-clinical through launch. We can help with the introduction of a new product or process to a site including:

  • Structure and processes in place for successful product introduction.
  • Team building.
  • Project management.
  • Site readiness and gap analysis.
  • Timelines and metrics.

Including other areas often overlooked, such as:

  • Warehousing.
  • Packaging activities.
  • Serialisation readiness.
new product introduction

Technical Transfer (TT) and Scale up

 

There are many process transfers during the lifecycle of products from R&D to pilot facilities and ultimately commercial scale GMP manufacturing.

We can help you ensure success with your technical transfer/process scale up including:

  • Project manage the scale up and transfer of new and existing products, both to internal and external sites.
  • Selecting the right partners such as manufacturing, analytical and packaging providers.
  • Technical transfer planning and documentation.
  • Validation master plans.
  • Document templates and reports.

2023 ATMP Review

The Advanced Therapeutic Medicinal Products (ATMPs) sector is evolving rapidly and new products have already demonstrated the ability to reverse or significantly impact the progression of disease. In recent years, the advent of cell and gene therapies has shown the...

Contact us

Get in touch anytime – we are always available to discuss your upcoming projects.