[vc_row full_width=”stretch_row_content” full_height=”yes” content_placement=”middle” parallax=”content-moving” css_animation=”bottom-to-top” leaf_row_scheme=”0″ css=”.vc_custom_1655529912282{padding-right: 10% !important;padding-left: 10% !important;background-image: url(https://www.access2hc.com/wp-content/uploads/2014/09/victoriano-izquierdo-HoevDVvxInw-unsplash-scaled-forest.jpg?id=9678) !important;}”][vc_column][vc_custom_heading text=”Gateway to Expansion” font_container=”tag:h1|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][vc_custom_heading text=”Full Suite Regulatory Execution” font_container=”tag:h2|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][/vc_column][/vc_row][vc_row css_animation=”bottom-to-top” leaf_row_scheme=”0″][vc_column][/vc_column][/vc_row][vc_row full_width=”stretch_row_content” full_height=”yes” content_placement=”top” parallax=”content-moving” css_animation=”bottom-to-top” leaf_row_scheme=”0″ css=”.vc_custom_1655529710730{padding-right: 10% !important;padding-left: 10% !important;background-image: url(https://www.access2hc.com/wp-content/uploads/2022/06/fb37e138409680c8d987.jpg?id=9676) !important;background-position: center;background-repeat: no-repeat;background-size: cover !important;}”][vc_column width=”1/2″][vc_custom_heading text=”Multi Country Expertise” font_container=”tag:h1|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][vc_column_text]We have established a talented team on the ground who has many years of local MedTech regulatory experience and management of local health authorities. As such, we can process regulatory approvals smoothly.
Over years, we have encountered hundreds of SMEs, start-ups, research with many different technologies or clinical applications. Our experience allows us to understand your products, rendering ourselves to ask the right questions and correctly determine the quickest, most cost-effective regulatory pathways. In some countries, reimbursement pathways are also established.[/vc_column_text][/vc_column][vc_column width=”1/2″][/vc_column][/vc_row][vc_row full_width=”stretch_row_content” full_height=”yes” content_placement=”middle” parallax=”content-moving” css_animation=”fadeInUp” leaf_row_scheme=”0″ css=”.vc_custom_1652436791262{padding-right: 10% !important;padding-left: 10% !important;background-image: url(https://www.access2hc.com/wp-content/uploads/2021/12/Transitioning-with-Ease.png?id=8487) !important;}”][vc_column width=”7/12″][vc_custom_heading text=”Technology Awareness” font_container=”tag:h1|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][vc_column_text]This extensive knowledge pooling is what makes us unique. We are able to appreciate and understand many complex technologies, and therefore, the most appropriate regulatory strategy can be developed faster. The required documentations are more accurately put together, and any potential risks are identified quickly.[/vc_column_text][/vc_column][vc_column width=”5/12″][/vc_column][/vc_row][vc_row full_width=”stretch_row_content” full_height=”yes” content_placement=”middle” parallax=”content-moving” css_animation=”fadeInUp” leaf_row_scheme=”0″ css=”.vc_custom_1652436816726{padding-right: 10% !important;padding-left: 10% !important;background-image: url(https://www.access2hc.com/wp-content/uploads/2022/05/maria-ziegler-jJnZg7vBfMs-unsplash-scaled.jpg?id=8967) !important;}”][vc_column width=”7/12″][/vc_column][vc_column width=”5/12″][vc_custom_heading text=”License Holding” font_container=”tag:h1|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][vc_column_text]Our country offices are all held under one ownership. They are, therefore, fully controllable and as the agreement is signed with us centrally, our resources and infrastructure will be at your disposal. Less complexity, less mess.[/vc_column_text][/vc_column][/vc_row][vc_row gap=”1″ css_animation=”fadeInUp” leaf_row_scheme=”0″ css=”.vc_custom_1652436830015{padding-top: 80px !important;padding-right: 10% !important;padding-left: 10% !important;}”][vc_column][vc_column_text]
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 is interested in developing long-term connections with companies interested in expanding their market presence.
We already have skilled team members with years of regulatory experience in the medical device industry. Our local resources enable us to quickly process regulatory approvals. On the other hand, the service fee is set and covers the whole regulatory clearance process. Frequently, the annual fee with itemized add-ons is packaged with the independent license holding. Our regulatory coverage extends outside the countries in which we operate, such as the United States for FDA approvals.
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Our wholly-owned physical offices in 10 countries help you alleviate these challenges, minimise schedule delays
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We have our own in-country team, no concerns of intellectual property leaking out
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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.
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With our vast resources and infrastructure, we can simultaneously launch your product in various markets! Check out our case study.
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En ISO13485 audits, technical file evaluation, clinical assessment report review, and consulting on medical device usability) and our EU Regulatory Affairs office in Germany. We cover MDR 2017/745 and IVDR 2017/746 in the European Union.
[/vc_column_text][vc_empty_space][vc_tta_accordion shape=”round” c_icon=”triangle” active_section=”0″ css_animation=”fadeInUp” no_fill=”true” collapsible_all=”true”][vc_tta_section title=”REGULATORY STRATEGY AND EDUCATION” tab_id=”1575125518765-a5e60b9d-17dd”][vc_column_text]-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[/vc_column_text][/vc_tta_section][vc_tta_section title=”TECHNICAL FILE” tab_id=”1575125518766-825c3225-9631″][vc_column_text]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[/vc_column_text][/vc_tta_section][vc_tta_section title=”LICENSE HOLDING” tab_id=”1575125690133-244b177a-550b”][vc_column_text]– 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. Learn more
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– 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
[/vc_column_text][/vc_tta_section][vc_tta_section title=”TRADE COMPLIANCE” tab_id=”1575126302405-db3a1915-b264″][vc_column_text]– Trade compliance expertise that ensures smooth and painless import and distribution practice
– We advise on customs clearance through Trade Compliance Education[/vc_column_text][vc_empty_space][vc_empty_space][vc_empty_space][/vc_tta_section][/vc_tta_accordion][vc_empty_space][/vc_column][/vc_row][vc_row disable_element=”yes” leaf_row_scheme=”0″ el_id=”map”][vc_column el_id=”map”][vc_column_text]
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
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Learn more about our Regulatory Consulting services in detail.
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EXTENSIVE KNOWLEDGE AND EXPERIENCE
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Our expertise enables us to fully comprehend your products, ask the appropriate questions, and accurately identify the shortest and most cost-effective regulatory procedures for your items. In certain countries, reimbursement avenues are also available for purchase. Over the years, we have come across hundreds of small and medium-sized enterprises (SMEs), startups, and research projects involving a wide range of technology or clinical applications.
This comprehensive knowledge pooling is what distinguishes us from our competitors. Many complicated technologies may be comprehended more readily, and the regulatory approach can be devised more quickly as a result. There is more precision in the preparation of documentation requests, and any possible dangers are addressed more promptly.
Faster regulatory clearances and a quicker market entrance procedure are the result of this approach.
[/vc_column_text][/vc_column][/vc_row][vc_row disable_element=”yes” leaf_row_scheme=”0″][vc_column][vc_empty_space height=”50px”][/vc_column][vc_column][vc_empty_space height=”50px”][vc_custom_heading text=”License Holding” font_container=”tag:h4|font_size:25|text_align:left|color:%23000000″ use_theme_fonts=”yes”][vc_column_text]This is our most sought-after service.
When a SME’s sales and business leads in another nation, it typically lacks the financial and people resources to create a subsidiary and engage sales and operations staff. Finding a distribution partner, who will initially shoulder the expenses of regulatory, marketing, storage and logistics is the first response.
As a result, market access and regulatory clearances take 6 to 24 months. This time, work, and chance are squandered if the distribution partner fails.
[Another scrollable section] What can we offer?[/vc_column_text][vc_custom_heading text=”We offer a better alternative” font_container=”tag:h4|font_size:25|text_align:left|color:%23000000″ use_theme_fonts=”yes”][vc_column_text]Access-2-Healthcare offers to be an independent ‘license holder’ – the authorised representative. We become the holder of the product license that is required for the product to be imported and sold in the country.[/vc_column_text][/vc_column][/vc_row][vc_row disable_element=”yes” leaf_row_scheme=”0″ css=”.vc_custom_1647932251501{background-color: #ffffff !important;}”][vc_column][/vc_column][vc_column width=”1/3″ css=”.vc_custom_1642310599368{background-color: #dddddd !important;border-radius: 2px !important;}”][vc_column_text]This means we complete the required clearances, and become your approved representative. We shall sign an agreement with any of your distribution partners with respect to product traceability and post market monitoring since we are ultimately accountable for the product in the nation.
This leaves oneself free to execute the sales/commercial agreement with the distribution partner for the product delivery. [/vc_column_text][/vc_column][vc_column width=”1/3″ css=”.vc_custom_1642310648460{background-color: #bcbcbc !important;}”][vc_column_text]Many license holding offers are strategic collaborations. The biggest hazards come when these collaborations are severed, placing the manufacturer in considerable legal problems.
Many license holding offers are strategic collaborations. The biggest hazards come when these collaborations are severed, placing the manufacturer in considerable legal problems.[/vc_column_text][/vc_column][vc_column width=”1/3″ css=”.vc_custom_1642310674568{background-color: #969696 !important;}”][vc_column_text]We can assist to interact with your distribution and storage partners with concerns to imports, complaints, and the tragic situations of product recall.[/vc_column_text][vc_empty_space height=”175.5px”][/vc_column][vc_column][vc_empty_space][vc_column_text]There are usually local offerings for license holding, and there are some regional/global options as well. Most of these regional/global offerings operate via strategic partnerships or joint ventures. This still works if and only if the partnership is intact.[/vc_column_text][vc_empty_space height=”50px”][/vc_column][/vc_row][vc_row disable_element=”yes” leaf_row_scheme=”0″ css=”.vc_custom_1647932264111{background-color: #dddddd !important;}”][vc_column][vc_custom_heading text=”What sets us apart? Risk reduction” font_container=”tag:h4|font_size:32|text_align:center|color:%23000000″ use_theme_fonts=”yes”][vc_column_text]
Because our country entities are all owned by a single group, the business risk is greatly reduced. This makes it easier for you to consider a different market to enter, because you will still be dealing with the same team, with the same high level of customer service.
Our country offices are all within one ownership group. Therefore, they are fully controllable and because the agreement is signed centrally with us, our resources and infrastructure become at your disposal. Less complexity, less mess.
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Research to Development Mentorship
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Investment Referral
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Medical Technology Design & Development
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Quality Systems Consulting
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Clinical site support
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Manufacturing scale up and set up
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Supplier Control Support
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Go-To-Market Strategy Services
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Full Suite Regulatory Services
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Business Due Diligence
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Licensing holding
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Regional Sales / Tech Service Hub
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