Projects and Companies

Sample of some of our recent projects.

Medical Device company names are kept confidential due to Non Disclosure Agreements. 

Medical Device: Regulatory/Market Entry Consulting.

1.) American company, world leader in IVD and Medical Device Software. Parkdale Group undertook  IVD and SaMD categorization and regulatory path planning and regulatory consultation for PMDA application. This company's technology required collection of identifiable patient data while using their SaMD enabled IVD system. Our research project clarified the rules for data management and process for data collection. This allowed for a successful application for approval with the PMDA and a product launch which would have been disallowed under the company's original plan. 

2.) European company: Innovator in implantable orthopedic materials. Parkdale Group undertook PMDA meetings for classification and clinical study sufficiency. Predicate search and analysis, and GAP analysis prior to PMDA application.  

3.) European Based Multinational Electronic Device Maker and Distributor. Parkdale Group undertook a business process alignment project to bring local company practice into alignment with PMDA and other Japanese Ministries requirements. We also help streamlined global processes to align with PMDA. 

4.) Major European Dental Equipment Manufacturer with multi-national operations. Parkdale Group undertook a multi-national supply chain regulatory consultation for medical devices that crossed national frontiers during manufacture. This project resulted in substantial time and cost savings, and a successful market entry to Japan. 

5.) German Hospital Equipment Company with multi-national operations. Parkdale Group undertook Regulatory Consultation on Categorization, Regulatory Pathway, and Market Intelligence.  We discovered and verified that several of the company's products were not medical devices in Japan prior to meetings with the PMDA. This led to substantial time and cost savings, quicker regulatory approval. This also allowed the company to realign its operations in Japan to service the non-Medical Device market efficiently. 

Medical Informatics:

Parkdale Group has access to an important network of specialists in the Medical Informatics field in Japan. We help companies make the connections and find the partners that can bring success in Japan. 

Regulatory Intelligence:

Parkdale Group undertakes detailed analysis of the most recent changes and updates in the regulatory landscape in Japan. The PMDA has committed itself to be the world's premier Pharma and Medical Device regulatory body, and we can keep you updated with our monthly reviews, and custom research on specific regulatory topics. 

Company Setup and Management:

Success in the Japanese market requires a display of commitment and devotion to the market. A key way to show this commitment is to set up a subsidiary in Japan. With our expert partners, Parkdale Group Inc can help you set up a corporation in Japan, open a bank account, and get a solid footing in the country. Your Japanese customers and partners will definitely be much happier dealing with a local subsidiary, and  this can dramatically reduce your complications in gaining traction in the market. Contact us for more information on how we can get you set up in Japan.

Send an email to info@parkdale-group.co.jp 

Parkdale Group Inc. works at the highest professional level with a network of business partners in Japan to deliver the very best in regulatory consulting, business strategy, and business development on the ground. We will consider funded projects from companies with interesting and beneficial technologies.