Client Profile
This client represents a unique multinational collaboration that led to the formation of a health supplement company registered in Ireland, focusing on a cognitive health product sourced and manufactured in Japan. The venture involves cross-border partnerships with entities in Europe, North America, and Asia, addressing complex regulatory landscapes, product development, clinical trials, and international marketing. The product is designed to support brain health in areas related to dementia and cognitive decline.

Project Scope

remarkable. has provided extensive support spanning business establishment, regulatory affairs, translation, transcreation, marketing, logistics, and international coordination, including:

• Leading company formation processes in Ireland in partnership with specialized formation firms, handling majority of communications and filings.

• Coordinating legal, tax, and financial advisory services for the newly formed entity, including VAT registration and compliance.

• Managing banking setup, payment processing, and contract drafting with partners and distributors.

• Supporting product launch and market entry strategies targeting EU countries (Germany, France, Italy, UK, Spain), the US, Taiwan, Thailand, and other Southeast Asian countries, as well as Canada following US regulatory approval.

• Facilitating ongoing regulatory submissions, clinical trial communications, and documentation translations related to the flagship product.

• Managing translation and localization of marketing content, website materials, and medical conference communications.

• Assisting with logistics coordination, including warehousing and international shipping partnerships in Japan and planned transitions to Ireland.

• Advising on FSMP (Foods for Special Medical Purposes) determination for EU regulatory compliance.

• Supporting e-commerce setup and management via Shopify, including payment integration, content management, and sales channel optimization.

• Participating as an investor in the health supplement company alongside other independent investors.

• Dedicating time to study and understand the scientific mechanisms behind the product to ensure credibility and scientific validity in marketing efforts.

Challenges

Navigating complex and evolving international regulatory environments for health supplements related to dementia and cognitive decline.

• Coordinating multi-jurisdictional legal and tax compliance while ensuring operational continuity.

• Managing multilingual content creation and cultural adaptation for diverse markets.

• Balancing startup operational tasks with strategic growth planning across multiple continents.

• Overcoming logistical challenges related to cross-border warehousing, shipping, and VAT registration requirements.

Solutions Provided

1) Business Formation and Corporate Services

remarkable. led the majority of the Ireland company registration process, working closely with formation specialists to ensure full compliance and timely setup. This included ongoing coordination of tax registration and banking.

2) Regulatory Affairs and Clinical Trial Support

remarkable. managed detailed technical translation of regulatory documents, collaborated with legal counsel to ensure clinical trial approvals, and coordinated communications with research institutions conducting product efficacy studies.

3) Marketing and Content Localization

remarkable. developed and localized high-impact marketing and educational materials, ensuring culturally appropriate messaging for each target market and supporting digital presence enhancement.

4) Logistics and Supply Chain Coordination

remarkable. coordinated warehousing and fulfillment services in Japan, managed international shipping arrangements via DHL, and advised on the transition to European logistics providers to optimize cost and efficiency.

5) FSMP Regulatory Support

remarkable. provided advisory services and coordination related to the determination and compliance of the product under the EU’s Foods for Special Medical Purposes regulations, ensuring readiness for market entry.

6) E-commerce and Sales Channel Management

remarkable. set up and manages the company’s Shopify store, handling content creation, payment integrations, and systemization through Shopify apps to streamline online sales and customer experience.

7) Strategic Investment

remarkable. invested alongside other independent investors in the company, aligning business interests with hands-on operational support and strategic guidance.

Results & Impact

• Successful incorporation and regulatory compliance of the new company in Ireland.

• Effective market entry planning for multiple major markets, including EU countries, the US, Taiwan, Thailand, and other Southeast Asian countries, with plans to expand into Canada after US approval.

• Strong collaborative frameworks established with legal, regulatory, and logistics partners.

• Streamlined cross-border operations facilitating efficient product launch and growth.

• Enhanced stakeholder confidence through clear communication, expert advisory, and hands-on project management.

• Established a sustainable e-commerce presence via Shopify, supporting organic sales growth and lead generation.

• Demonstrated scientific understanding underpinning marketing efforts, reinforcing credibility in the dementia and cognitive decline health space.