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Slide Notes

Colombia, strategically located close to the US and on the same EST time zone, offers many strengths for medical device trials: It is the third-most populous country in Latin America, after Mexico and Brazil, and it's considered the most urbanized Latin American nation. Nearly 89% of its 50 million people live in big cities. It has a centralized healthcare system that draws patients with particular needs to specialized or regional hospitals.
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bioaccess.™ Company Profile & Capabilities

Published on Nov 18, 2015

bioaccess.™ is a US-based contract research organization (CRO), regulatory, and market access consulting company that delivers a full spectrum of offerings from bench to commercialization so that foreign manufacturers of medical devices can have long-term success in Colombia and the rest of Latin America.

PRESENTATION OUTLINE

We bring Latin America closer to you

CRO. Regulatory. Commercialization
Colombia, strategically located close to the US and on the same EST time zone, offers many strengths for medical device trials: It is the third-most populous country in Latin America, after Mexico and Brazil, and it's considered the most urbanized Latin American nation. Nearly 89% of its 50 million people live in big cities. It has a centralized healthcare system that draws patients with particular needs to specialized or regional hospitals.
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Medical device companies struggle to either find an investigator for their first-in-human clinical trials or to sell their products in Latin America.

This is due to unfamiliarity with the region and lack of in-house experts to help them operationalize a successful strategy.

We at bioaccess.™ bring Colombia and the rest of Latin America closer to foreign medical device companies.

Photo by kylemac

Our promise is for foreign medical device companies that believe that Latin America offers untapped potential to conduct early-stage trials and sell their products. We focus on forward-looking medical device companies that want to run a first-in-human clinical trial and want to have long-term sales growth in the region.

We promise that by engaging with us as your CRO, regulatory, or market access consultants, your company will cost-effectively get the clinical data it needs or will be able to increase its sales in Colombia and the rest of Latin America.

Photo by Nathan Fertig

Our Offerings

  • First-in-man clinical trials
  • Regulatory/marketing authorization/approval
  • Market research, distributor search, and market access consulting.
Medical Device Registration in Colombia

INVIMAREADY™: Medical device registration

Before manufacturers can legally sell products to, or within Colombia, they must be in compliance with Colombian device regulations and registration requirements. Medical Devices in Colombia are regulated by the National Institute for Medications and Food Surveillance (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, or INVIMA).

Interventional Concepts can assist with the preparation and submission of your device registration applications to INVIMA. We will compile your technical file, will review all labeling for compliance, and will provide post-submission assistance with INVIMA all the way through the approval of the device registration.

This includes,

An hour-long regulatory and business strategy session with you.
Search and selection of an INVIMA-certified importer of record (different from finding a commercial distributor).
When applicable, we will process the paperwork to transfer to your company's name any existing registration that a local distributor may have in Colombia for your medical device.
Review of documentation and classification of your product.
If needed in special cases, we will send INVIMA a formal petition letter to seek the agency's opinion on product classification and specific document requirements.
Preparation and submission of the final dossier package to INVIMA.
Answering post-submission follow-up questions from the INVIMA reviewer.


MARKREADY™: Trademark registration

In order to protect and have rights over a trademark in Colombia, it has to be registered locally through the Superintendence of Commerce and Industry (SIC). This service includes:

Trademark Search in Colombia: Determine the probabilities your trademark has of being successfully registered in Colombia
Trademark Application in Colombia: Apply to have your trademark registered in Colombia
Search Report In Colombia: reports are only offered for word elements. Delivery time: 5 business days (approx.).

Application: Approximate process duration for straightforward cases is 4 months.


REPREADY™: Regulatory legal representation

You are required to appoint a local regulatory legal representative as part of your regulatory approval process with INVIMA. Your legal representative in Colombia will manage your product registration process, will interact with INVIMA on your behalf, and will ensure compliance with the local post-marketing surveillance requirements. You must maintain your legal representation relationship for as long as you ship, market, and sell your product in Colombia.

Interventional Concepts S.A.S. (ICS), our local entity in Colombia, will act as your legal representative in Colombia, fulfilling all regulatory responsibilities per national health regulations. You will assign power of attorney to ICS to file regulatory submissions to INVIMA on your behalf and to receive request for information notices and appropriately respond to them. ICS covers the legal risk of doing business in Colombia, as, if there ever is a claim in Colombia relating to your product (even if the likelihood of such an occurrence is tiny), the party making the claim would enforce it against ICS. Due to the fact that this legal representative is a Colombian entity, the claimant and the courts would have jurisdiction over it.

ICS will also provide assistance related to communications with authorities in Colombia, will submit the required annual report to INVIMA (Article 24, Decree 4725 of 2005), and will ensure your importer of record or distributor has a current post-market surveillance program (PMS) and follows Colombian regulations (Ministry of Health, Resolution 4816 of 2008).

SALESREADY™: Distributor search & selection

Successful commercialization of your medical product in a particular market depends a lot on the type of medical product distributor you choose as a partner. Once you have determined which medical product markets best match your business development goals and registered your product according to national regulatory requirements, selecting a distributor that best complements your sales and marketing strategy is crucial.

Interventional Concepts can assist with the research and assessment of local distributors in Colombia based on the foreign manufacturer's specific requirements. Our services include review of the manufacturer’s selection criteria and business development goals, research of local distributors available in Colombia, leveraging on Interventional Concept’s extensive network, development of a clear plan of action to present to potential distributors on first approach, identifying their strengths and weaknesses, development of distributors profiles, compilation of evidence of their track record with products and companies similar to your, assessing pre-selected distributors, and selection of final distributor.

Finding the best medical distribution partners is in many ways just as important as obtaining regulatory registration for your medical product. In order to find and screen potential distribution partners for your chosen medical products markets, you should first have a clear idea of your business development strategy.

Once this strategy has been defined and provided to Interventional Concepts, the following key considerations will be utilized:

Who the manufacturer's current competitors in the chosen medical product markets are
Where the manufacturer’s competitors are concentrated
How the manufacturer’s product compares to those of its competitors in terms of quality and cost
Reimbursement as a possible issue in chosen markets
How well-served the chosen markets already is by products similar to the manufacturer's
What the future growth trajectories for the manufacturer’s chosen markets are
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Trusted by many

 Volcano, Abiomed, ClarVista, CeloNova, Mitralign, Sanuwave, Avinger, Omron —and more!
Clients such as the University of Miami (DirectFlow Medical, NeuroTronik), Mitralign, Roxwood Medical, InterValve, Avinger, CeloNova BioSciences, Syntheon Medical, MitraSpan, Kona Medical, among others, have trusted us with their clinical trials in Colombia.
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"Preparation for the Colombia trial entailed an enormous amount of time and effort, and it is a credit to our internal team and the folks at bioaccess.™ who worked together seamlessly to meet our tight schedule."

— Robert Bergman, CEO, Hancock Jaffe Laboratories, Inc.

Photo by Ambreen Hasan

"This decision to engage bioaccess.™ was made to increase our focus and visibility within South America. It is of the utmost importance that we partner with distributors that have influence and a good track record within the Colombian market."

— André Mouton, V.P. International Sales and Relations of SANUWAVE Health, Inc.

Photo by wealldo

First-in-Human Clinical Trials

  • Study design
  • Site selection
  • IRB and MoH (INVIMA) approval
  • Study start-up
  • Study management and monitoring
  • Importation of investigational devices
  • Study management and monitoring

Regulatory Consulting

  • MoH submission for market clearance/approval (Colombia, Mexico, Brazil)
  • In-country legal representation
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Market Access

  • Market research
  • Market access plan
  • Distributor search
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bioaccess.™: CRO. Regulatory. Commercialization

We bring Colombia and Latin America closer to you.