Development
Our Development Division consists of the following departments and disciplines:
CLINICAL
Our clinical development team are responsible for demonstrating the safety and effectiveness of our products in treating patients. We do this with doctors and their teams, often throughout the world, in running clinical trials. Our physicians and scientists design and plan our clinical trials, with help and collaboration from our development colleagues.
We often run these studies with assistance from contract research organisations (CROs). Depending on how complex these studies are they can take from a few months to over three years to complete. The information and data are then collected and analysed. These data then form part of the regulatory documentation needed to get approval to market and sell our products around the world.
The investment in clinical trials can often be some of the largest financial investments a pharmaceutical company makes - by working with doctors and their teams we can ensure that our clinical development programmes collect the correct data, efficiently, and that we make better medicines relevant to the unmet needs of patients.
PHARMACOVIGILANCE
Pharmacovigilance monitor the safety of ProStrakan products both during development and post-launch including those licensed to international partners. Information must be monitored and reviewed regularly and potential for product safety issues evaluated. If safety advice needs to be changed on our products, pharmacovigilance work with the regulatory affairs department and the health authorities to make sure appropriate changes are made and rolled out worldwide in a timely manner.
PROJECT MANAGEMENT
The project management group has responsibility for leading the global multi-disciplinary Product Development Teams to deliver products that are optimised for commercial success to agreed specification, time, budget and quality standards. In addition to the management and planning of individual projects, the group ensures integration of all projects into the overall development portfolio, including life-cycle management considerations for existing commercialised projects.
QUALITY ASSURANCE
The Quality Assurance (QA) function at ProStrakan ensures that written standards (control led documents) are in place that define the Quality System for management of processes essential to the company business and those, which require to be managed for regulatory compliance. QA liaises with contract managers, and checks by audit, to ensure the quality and quality assurance processes are incorporated into each contract and put in place.
REGULATORY AFFAIRS
The Regulatory Affairs Group are responsible for the presentation of registration documents to regulatory agencies, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorisation for the products concerned. They keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products and advise on the legal and scientific restraints and requirements, and collect, collate, and evaluate the scientific data that their research and development colleagues are generating.
