REGULATORY COMPLIANCE IS ONE OF THE GREATEST CHALLENGES IN MARKET ENTRY
The uniqueness of Access-2-Healthcare’s infrastructure offers many advantages for the MedTech SME:
Access-2-Healthcare seeks to build deep, long-term relationships with your market expansion plans.
Our wholly-owned physical offices in 10 countries help you alleviate these challenges, minimise schedule delays
We have our own in-country team, no concerns of intellectual property leaking out
Our in-country teams are in tune with the latest updates of the local regulations, all the regulatory risks are pre-checked before submission, to ensure that the entire process is smooth, without undue delay.
For Product License Stewardship (“license holding”), as we own our own offices, and combine this with the expertise of our in-house Regulatory Affairs team, this ensures a consistent quality of service.
– Develop regulatory strategy for your organization, including providing up-to-date regulatory news for more effective planning
– Help you develop internal infrastructure for effective regulatory deliverables in your existing company network
– Educate R&D and manufacturing to incorporate regulatory requirements in design control , especially in specific local standards and testing
– Translation of technical documentation to local language as necessary
– Audit and Remediation of your Technical File – we help you fix the leaks, and adapt it for various countries’ use
– Manage change notifications and product extensions
– Separate and de-couple legal from business responsibilities – Access-2-Healthcare physically owns business entities that are legally able to maintain your product/import license. Find out where we can do this.
– One company ownership for all entities – single point of contact, same quality of service
– Importation continues regardless of business status – not impact end-customer, protect market share and access to healthcare
– Better performance management of business partners and able to concentrate on finding more sales/marketing talent to maximise market coverage
– Our Services extend to include post market surveillance coverage – Adverse Event Reporting / Product Recall Management.
– We help you remove the regulatory burden from both distributor and manufacturer through reportability decision making, actual form filling
– No unnecessary disruption of business by regulatory authorities
– Ensure successful inspection results by regulatory authority
– Trade compliance expertise that ensures smooth and painless import and distribution practice
– We advise on customs clearance through Trade Compliance Education
CURRENT LIST OF MARKETS THAT WE SUPPORT TODAY
The location pin represents our country entities that are able to be your independent Authorized Representative, Sponsor, or Agent
Click on the location pin, and you can see the regulatory services we provide in each country