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Gary Baylis

United Kingdom, Birmingham
Regulatory Adviser
REGISTRAR CORP USA

About Gary

After 50 years in the international logistics industry Gary established his own company, Export Access, with a view to helping UK companies understand how to export, how to gain access to foreign markets and how to deliver goods to overseas customers.
Working closely with the Department for International Trade, Chambers of Commerce, Industry & Trade Associations, Banks, Universities and International Trade Support Organizations Gary is on a personal mission to educate and inform exporters, so that they are properly prepared to exploit opportunities in overseas markets.
Gary runs the representative office for UK & Ireland for Registrar Corp USA – the leading global provider of assistance services for foreign suppliers whose products are subject to regulation by the US FOOD & DRUG ADMINISTRATION (FDA).

FDA regulations are challenging, complex and ever evolving, so they present a formidable barrier to US entry for many exporters.
Registrar Corp is the leading global provider of FDA compliance assistance services. Over the last 15 years, we have helped more than 30,000 companies in 160 countries achieve ongoing compliance by providing comprehensive, easy to access and cost-effective assistance services.

 

Speaker's Sessions:

1570789800
1570789800 - 1570792500
Elgar Concert Hall
English

Panel: Going to America?

The US Healthcare market is valued at more than $2.8 Trillion and is frequently the number one priority for UK / Europe life sciences companies looking to expand their international presence and set up foreign subsidiaries. A US presence also facilitates the access to the US investment and capital markets, and the downstream opportunity to IPO via the Nasdaq equity market.

Whilst there are many similarities in business approach and language, there are also significant cultural and legal differences which can catch out the unwary when seeking to establish and operate a local entity.
Expanding into new markets, geographies, and market segments can be immensely rewarding but also challenging if approached without adequate preparation, knowledge and support. Companies need to think strategically about which avenues they need to explore to develop realistic market access strategies that create the opportunity for growth and long-term value creation.

Our expert panel will provide well informed advice as to how best to approach establishing a North American entity and develop practical strategies and plans to optimise operations, organisational structures, financials and processes across the life sciences value chain to maximise their chances of business success in this dynamic healthcare market.

Our panel will offer advice on the following topics:

Location
  • East, West, or Middle – are there areas more suitable for R&D or manufacturing operations?
  • Impact of time zones, access and travel
  • What are the varying incentives and taxation differences between States
Legal
  • FDA clearance and approval to obtain FDA certification
  • Risk management and insurance provisions to consider
  • Incorporation or branch legal structure?
  • Visas, relocation, tax, immigration issues
  • Differences in IP between the UK and US e.g. first to file vs first to invent
Business
  • Understanding how the health system works
  • Access to investment, capital, grants and where to leverage practical setup support
  • Tips on recruiting & retaining local staff
  • Identifying and interacting with a new range of US out-source partners
  • Local networking and interaction with the community
Speakers