Business Development & Outsourcing
Over the past 10 years the Pharmaceutical Industry has been driven to look for innovative and cost-effective ways to carry out both regulatory and non-regulatory processes for both short and long term projects. This has happened at a time when the requirement to be ever more compliant as an industry has never been higher.
As a result, when conducting inspections, the Regulatory Authorities focus heavily on those outsourced processes, looking to see whether Pharmaceutical Companies have performed proper due diligence and maintained proper oversight of those activities in line with the legislation surrounding the roles and responsibilities of being the Sponsor, in Clinical Trials, or as a Marketing Authorisation Holder/Licence Holder. The recent fines and sanctions imposed on Pharma Companies have been punitive, ranging from 5% of annual turnover to licence suspensions or delays in licence approvals where activities and processes are not performed correctly.
How can our Business Development team help?
Our highly experienced Business Development team can help you to determine the level and types of services your company requires to solve your requirements and provide compliant, cost-effective, innovative strategies for long or short term solutions. The team are used to handling contracts over a varied range of client type and value, from multi nationals to start ups, with a wide range of service requirements. All of our existing or prospective clients, irrespective of size, receive the same level of quality, attention to detail and reliability, in line with our best customer service practices.
We value the long term relationships we have built up with our clients, many of whom have been with us for over seven years and the longest has been with us for 12 years. These relationships continue as a result of our sustainable approach to long term customer service, compliance through expertise, training and the systems we have in place.
The team are dedicated to maintaining and further developing the relationships with our existing clients and bringing new clients on board to experience our unique attention to customer service and Quality. Your dedicated Business Development Associate will ensure that all aspects or your contract are being run to your expectations, offering a single point of contact and ‘One Stop Shop’ approach to your requirements. Our cost proposals are presented with no hidden surprises in store once you have committed to work with us.
We successfully operate as the Outsourced Pharmacovigilance and Medical Information Departments for a number of companies. For newly awarded contracts, we allocate a team who are well versed in the process of setting up new clients to coordinate the various parts of the process required to ensure we are in a position operate effectively and compliantly by the agreed ‘go live’ date. They will give continuous updates on the progress of the project against any agreed unified plan.
Our main aim is to make sure that your company is compliant and remains compliant on an ongoing basis.
What Outsourcing Services can we provide?
Pharmacovigilance, Cosmetovigilance, Medical Services, Audits & Inspections, BD & Outsourcing, Due-Diligence; Consultancy and practical help on product acquisitions and integrations, Validated Safety Database installations, Case processing, PSMF Production, Safety reporting plans, Specific work practices, SDEAs, Risk Management Plans, Literature searching, FAQ’s, Eudravigilance, XEVMPD Database Set up, DSUR’s, PSUR’s, PBRER’s, USA PADER’s, Safety/Signal reviews, SOP writing, eCTD formatting, Provision of 24/7 cover for answering medical enquiries, QPPV, EU QPPV, Deputy QPPV and training.
Outsourcing – The perils & pitfalls of choosing your Pharmacovigilance Partner
Pharmacovigilance for many years remained in the background within the Pharmaceutical Company but in recent years, drug safety has moved into the media spotlight and now more than ever it is essential that patient safety is seen to be of paramount importance to pharmaceutical companies. Click here for more information on the perils and pitfalls
To discuss any of our services please contact us on + 44 (0) 1483 212150 or email bd@pharsafer.com