Solutions Case Studies
We have helped companies ranging from new companies with an interesting technology, through mid-size companies going global in Japan, to Fortune 500 companies solve problems with Japan.
Examples
1.)
Company ‘B’, Fortune 100, World leader in IVD and Medical Device Software.
Country: USA.
Product: SaMD system for collection and analysis of patient vital signs and analysis using AI having regulatory challenge in Japan.
Problem: Inconsistency in Regulation between US and Japan on handling personal medical information with a SaMD.
Parkdale Group Solution: SaMD categorization and regulatory investigation.
Regulatory Consultation with PMDA.
Investigation of Health Ministry and General Affairs Ministry rules on data handling.
Investigation and clarification of rule for info handling:
Outcome: Product now entered the Japanese market with correct data handling protocol to become major device in Japan.
2.)
Company ‘GmbH D.’ Major European Dental Equipment Manufacturer:
Country: Switzerland.
Product: Dental Implants.
Problem: Breakdown of Multi-national supply chain due to regulatory issues regarding classification of dental implants.
Parkdale Group Solution: Research on classification and regulatory trouble shooting.
USA-Japan regulatory comparison investigation.
Outcome: Reestablished functioning supply chain.
3.)
Company : GmbH ‘F’ : Manufacturer and distributor of pre-filled syringes.
Country: Switzerland, Germany.
Product: Syringes.
Problem: Unique regulatory treatment in Japan for syringes and pre-filled products causing major headache for head office as the local company in Japan was unable to adequately handle the product.
Parkdale Group Solution: Regulatory investigation, consultation by Medical Device experts, and interpretation of pharma regulations for pre-filled devices.
Outcome: Company rationalized its operation in Japan and allowed improved business performance.
Contact us to help us understand any problems you are having in Japan.
Email: info@parkdale-group.co.jp