Upasana Prabhakar, Founder, and owner of PharmaVigilance
Pharma companies face a myriad of issues when they outsource the Pharmacovigilance (PV) medical writing work to offshore companies. The main challenge is being compliant with PV regulatory requirements while the low quality of reports triggers inspection from various regulatory authorities around the world, which further damages their reputation.
“We understand exactly how critical it is to maintain the quality of services to maintain compliance with regulatory requirements,” begins Upasana Prabhakar, founder, and owner of PharmaVigilance. Her 20-year track record of working in this industry is what helps her to provide those services at competitive rates and display the flexibility to cater to different types of projects.
Upasana implements a proactive approach to managing data queries and providing suggestions and ensures completion of all writing projects within the given deadlines. With high standards of quality, she prepares all documents according to relevant guidelines and offers a flexible, cost-effective pricing structure. PharmaVigilance has a unique model where the operations for outsourced work are carried out not only by the employees but it also avails the services of independent PV professionals, including ex-regulators in the UK, when required.
The firm provides services mainly in the area of drug safety. This includes writing PV related documents such as PSURs, RMPs, PSMF, PV SOPs, and DSURs. “We conduct PV audits and prepare clients for regulatory inspections by performing gap assessments and mock inspections,” adds Upasana. The company extends full PV support to the pharma companies seeking regulatory approval in the EU by providing guidance and writing documents required during the application process.
“We provide advice and suggestions proactively during a project rather than simply following the instructions,” adds Upasana.
The project team proactively raises any discrepancies much earlier during the project to avoid any confusion and delays towards the end of the project.
We understand exactly how critical it is to maintain the quality of services to maintain compliance with regulatory requirements
Upasana has built strong, long-lasting relationships with the clients by providing services with a personal touch and by maintaining effective communication with them. Clients can completely count on PharmaVigilance even if the data they are providing to perform the task has not been thoroughly checked at their end, as PharmaVigilance will check for any errors or gaps, and will proactively correct them. “We provide this assurance to our clients, and hence they do not have to worry too much on the quality of the data provided either from their end or the quality of deliverables from our end,” states Upasana.
For instance, a small pharma company was applying for Marketing Authorisation in the EU and needed help with PV related documentation. PharmaVigilance worked on the RMP, PSMF, and SOPs for the client’s product. However, the client did not want to include some risks in the RMP, assuming that the authorities would apply restrictions if they mentioned all the risks. PharmaVigilance suggested otherwise that as long as the client was transparent about all risks and could convince the authorities that they would take appropriate measures to monitor the risks, it would not be a problem. Still, if they chose not to present those risks, the highly experienced assessors would definitely question them and might object, which would delay the authorisation procedure. The client agreed with the proposal and managed to sail through the RMP approval without any objections.
“The main mantra for customer satisfaction is to win their confidence in the quality of work that we perform and to show flexibility when they need services urgently within short timelines,” states Upasana. Even though PharmaVigilance currently has a short run in the industry, its clients have chosen to continue availing its services rather than moving on to the big players in the market. “The fact that we get repeated business from our clients is a piece of evidence enough to prove the excellent quality of our services,” concludes Upasana.