Since our establishment in 2019, we have been engaged in supporting compliance for many pharmaceutical companies. We provide consulting services not only to domestic and foreign pharmaceutical companies but also to CROs and research companies.

Major support activities

1.Consulting (Advice on compliance when interacting with HCPs and HCOs)
2.Support for Rules (company policies, SOPs, manuals, etc.)
3.Compliance Training
4.”Third-party” roles as specified in the MHLW’s Guidelines on Sales Information Provision Activities
5.Other activities

― List of Clients and Our Roles

Clients Consulting Company Rules Training Third Party Member
of Committee
Pharma A(APAC) ✓※1
Pharma B(APAC)
Pharma C(Europe)
Pharma D(Europe)
Pharma E(Europe)
Pharma F(U.S.) ✓※2
Pharma G(U.S.) ✓※2
Pharma H(Europe)
Pharma I(Europe)
Pharma J(Europe)
Pharma K(U.S.)
Pharma L(Europe)
Pharma M(Europe)
Pharma N(U.S.)
Pharma O(U.S.)
Pharma P(U.S.)
Pharma Q(Europe)
Pharma R(Japan)
CRO A(Japan)
Research Company A (Japan) ✓※3

As of October 2023

※1 External advisor to the Donations Committee
※2 Risk Assessment
※3 Support for Preparation of Questionnaires

Formulation of Company Rules that PhI has supported

Details outlining the support for company rule preparation are presented as percentages for each item. Lately, we have been receiving requests to set up various internal rules and standards by our clients. At PhI, we assist by thoroughly explaining the nuances between global and Japanese rules, while also taking into account the most recent regulatory trends.

Compliance Trainings that PhI has provided

PhI primarily serves clients with foreign affiliations, often known as Gaishi-kei. As the demand to understand the differences in regulatory structures in Japan, the United States, Europe, and APAC is increasing, PhI is proud to be a company that has outstanding knowledge about “differences in regulatory structures with overseas” compared to other consulting companies.
Our unique selling point is our specialized training on the variations in regulatory frameworks between Japan and other nations, an offering that has garnered significant praise.
Our training extends beyond just commercial divisions, encompassing diverse sectors such as:

1.Executive Management
2.Compliance Officers
3.Medical Advisors/Medical Science Liaisons (MA/MSL)
4.All Employees
5.Mid-career hires
6.Health Care Professionals (HCPs)
7.Custom sessions tailored to client requests

Our expertise is evident in the over 150 sessions we’ve conducted, with notable emphasis on the Fair Competition Code and the MHLW’s Guidelines for Sales Information Provision Activities, thanks to consistent and repeated client engagements.