Our Regulatory Consulting have decades of experience helping teams interpret new and existing guidance throughout the process. Novomedika RA has plenty experience in product registration submissions and have managed local certifications process as Inmetro (Brazil) & NOM ( Mexico).
We work with the best and most experienced regulatory, quality and compliance experts to help assess, guide and strategize the most effective and comprehensive path for each product. Regulatory pathways and quality requirements can be different for every country, region and the classification of the product. With decades of experience both in-house and through our extended network, our team provides one of the best “customized” guidance through what can be a very complex field.
We are one-stop shop for registration, technical and compliance services of your healthcare products in Latin America, with in depth knowledge around the following organizations:
COFEPRIS (Mexico) ANVISA (Brazil)
ANMAT (Argentina) INVIMA (Colombia)
FDA (US)
The ongoing transformation of the Life Sciences Industry has a direct impact on the suppliers of original equipment and manufacturing solutions.
To win in this new environment, medical device manufacturers have to rethink their business strategy, offering the right product to the right customer segments, producing equipment and parts quicker and more cost effectively and improving the organization’s overall service, flexibility and responsiveness.
Our dedicated team of experts provide creative solutions for your needs regardless of the shape, size or weight of your cargo, minimizing the cost and maximizing efficiencies.
We have 20+ years of experience managing technical service and its operation. Our technical consulting services support our clients’ needs in everything related to the technical aspects of medical products. Our areas of expertise are operating room infrastructure, and surgical equipment for minimally invasive surgeries.
Our technical service offering covers from the pre-sale support to the installation and post-sale services like preventive and corrective maintenance.
We count with a network of engineers to enable the technical support, training and service that our customers require in the Latin America countries where their products operate.
Our experts can assist with all your financial management needs including creating your company’s monthly financial statements, creating and regularly updating your proformas, providing monthly analysis of actual versus budget, aligning accounting records to enhance financial reporting, and more.
Our diverse service offerings cover all avenues of growth strategy and can be customized to help you pursue one or more of the strategic options that best fit your growth objectives and potential.
If your company is projecting revenues for your current product portfolio, an independent, unbiased and evidence-based evaluation will provide you with the confidence required to make winning decisions.
We apply a disciplined approach to arrive at accurate projections that help you reach your goals, including evaluating financing options within the marketplace
NovoMedika provides unparalleled opportunities to interact with Latin American health care industry representatives.
We provide our medical device manufacturers the ability to meet with healthcare providers in the Latin America market to be able to position our clientele to receive significant contract awards for the sale of their medical devices.
Our team will provide you with a business development channel that can lead the sale of your medical devices at virtually hundreds of hospitals.
Our goals are:
•Cut down your sales cycle by interacting with the appropriate hospital leaders.
•Deliver high profile contracts to help penetrate the marketplace with a key sale which can be used to support your long-term sale efforts.
•Ensure commitment from anticipated end users to accelerate time to positive cash flow with a confirmed market strategy.
Partnering with us comes with a commitment to connect your business with the right talent, with the confidence that they will be a long strategic fit with your organization.
Our niche is recruiting exclusively in the Medical Device industry.
We add value to your business, willing to go the extra mile. We are experts on our field and have a highly effective process for getting the right candidates for your job openings.
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