Below are examples of how our clients benefitted from our proactive involvement in helping them with their compliance.

APC Group was engaged to bring this company to full compliance and ensure they pass the inspection that was taking place in two months. During the handoff, APC Group learned that the company had been marketing products for many years but had not regularly produced Periodic Reports (PSURs) and literature searches were not regularly expedited over the years.

APC Group quickly assessed the situation and implemented systems to bring them to compliance. A comprehensive PSUR schedule was put in place, and retrospective literature searches were done and all relevant reports were expedited. Channels of regular communication were developed and kept open with the competent authority. In addition, the PSUR compilation was streamlined so that, today, all of the company's products have been covered in terms of PSUR submissions which are fully up to date.

The inspection found that excellent progress had been made and previous findings were downgraded. As a result, the company was brought to a compliance level which the regulatory agency would cover under routine inspections.

"International multi country Pharma Sales operations with Pharmacovigilance Outsourced to another service provider. Asked to transition to our Safety Database within a month. Our rapid Validation process and Ready Client setup protocols helped achieve this and the operations team prepared 100s of delinquent Periodic Safety Update Reports, bringing the company to an acceptable compliance level."

APC Group was asked to take over the existing outsourcing for this pharmaceutical company in less than one month. This company had a very large portfolio of products in many countries. Although their Drug Safety processes were outsourced, we found that the company had to compile PSUR's in-house. Due to the lack of adequate resources, there was a backlog of hundreds of PSUR submissions going back many years. The company was also submitting separate PSUR's for each product in each country where they had approved products.

Within one month, APC Group implemented the most essential systems in order to take over the PVG responsibility on time. APC Group has managed to accomplish a complete clearance of the PSUR backlog, within a year, and all submissions are now being done on time. Most importantly, a harmonized PSUR submission schedule has been agreed upon with all regulatory agencies so that one PSUR can cover all of the product licenses approved for that product .

 This client was in a drastically compromised state of compliance when APC Group was asked to take over, within six weeks of an impending inspection. The last consultant did not keep accurate records and did not provide any documentation on what had been done previously. Despite the knowledge of the challenges we would face on this project, APC Group took over the responsibility for the Pharmacovigilance.

Given the very short timeframe before the inspection, APC Group implemented a completely new Pharmacovigilance system. It had an immediate effect, and over a period of time, the system has ensured the company has achieved an acceptable level of compliance on a consistent basis.