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Launching an Audit Support Business: Leveraging PV Expertise to Propose Improvements

WysiWyg Co., Ltd. plans to launch a business providing audit support ‒ including mock audits and assistance with internal inspections—by leveraging the expertise they have cultivated in pharmacovigilance (PV) operations. This service aims to help pharmaceutical companies verify whether their operations meet regulatory requirements for GVP (Good Vigilance Practice) compliance inspections and manufacturing and marketing license renewals.

The initiative began after a mid-sized pharmaceutical company sought advice regarding challenges caused by personnel changes and a reliance on specific individuals for key tasks. WysiWyg conducted a mock audit and not only identified areas where the company’s response was inadequate but also proposed specific improvements. “The client’s appreciation was a major factor in our decision to commercialize this service; we want to help enhance the credibility of pharmaceutical companies through this work,” says Sokichi Ando, the president and CEO of WysiWyg.

PV operations require the proper collection, assessment, and reporting of safety information in accordance with GVP regulations. However, mid-sized pharmaceutical companies often face challenges such as limited staffing and insufficient handovers between personnel. Consequently, issues—such as inadequately prepared standard operating procedures (SOPs) or contracts and failures to address points raised in previous inspections—may only come to light before a regulatory inspection, leaving companies scrambling to respond.

Through their audit support service, WysiWyg conducts mock audits for companies facing these challenges, identifies issues in advance, and proposes operational improvements as needed.

When consulted by a company and undertaking an audit support project, WysiWyg assessed the company’s operational status against the checklist WysiWyg generated, identified discrepancies between SOPs and actual practices, and proposed improvement measures.

WysiWyg can provide this support thanks to the practical experience they have gained through their existing PV support operations. Leveraging their core business of medical translation, they have a long track record of handling tasks such as collecting overseas literature, assessing safety information, and assisting with the preparation of case reports. The audit support services are staffed by personnel with experience in safety operations at pharmaceutical companies, quality assurance specialists capable of reviewing GVP compliance and contracts, and safety specialists who understand practical workflows. Their key strengths lie in offering not merely critical observations but also realistic improvement proposals, all at a reasonable price point.

WysiWyg observes that, in recent years, concerns regarding “whether operations are truly being conducted appropriately” have intensified—particularly among mid-sized companies like generic drug manufacturers at the forefront of supply stability issues—as drug supply instability has become a social issue and regulatory requirements have tightened.

WysiWyg aims to contribute to enhancing the industry’s overall credibility by resolving these challenges. They are also considering offering services at more flexible and accessible price points, taking into account the scale of clients.

Furthermore, WysiWyg is moving to strengthen their safety-related medical writing services. While they have previously provided support for drafting clinical study protocols, clinical study reports, and drug approval application documents, they now intend to strategically expand the services by integrating these efforts more closely with safety operations, aiming to provide seamless support from development to post-marketing.

Regarding the commercialization of audit support services, Mr. Ando comments: “By engaging us, staff at mid-sized companies may gain new insights. Having grown thanks to our clients, we see this as an opportunity to contribute to the industry by sharing our experience, while also learning from the front lines ourselves. Ensuring proper operational practices at client companies leads to greater stability in the Japanese pharmaceutical industry, and we are confident that we can play a more vital role in supporting that process.”

For more information on safety information management services,
https://www.wysiwyg.co.jp/en/service-en/safety