A Regulatory Firm that stands out!
Never satisfied with the status quo, never stagnant, we strive hard to incorporate the newest regulatory and quality systems updates into our services, constantly fine-tuning the regulatory and quality advice we provide our clients.
For early stage startups or companies getting their new products to the market, we have offered:
- Acting Directors and VPs where we give you advice and translate that into results through a well structured and competent execution team
- Fully integrated execution team to augment the Client’s in house Director or VP personnel
For companies that are already in the market, we have offered:
- Acting Directors and VPs to advise on post market and effective compliance strategies that facilitate new product pipeline and alternate revenue source generation
- Fully integrated execution team to augment the Client’s in house team for volume based sustenance work
On the path to a successful new product launch, a company hits many regulatory hurdles. ELEXES is more than just a strong regulatory and quality support provider; we’re a trusted partner that works with Clients hand in hand to better understand their desideratum.
Companies have worked with us on:
- Go to market strategy for innovative medical devices
- Feasibility for a Breakthrough Device Designation with the FDA
- Early feasibility study protocol review for compliance
- Time and cost estimation for fundraising
- Cost-effective outsourced but integrated regulatory and quality departments
The journey to creating a successful medical device company does not end at the premarket stage, but it begins there. With the plethora of new guidelines being incessantly released, the government authorities expect compliance with the latest and most updated requirements at all times, and to fulfill the post market obligations.
We have been involved in:
- Ongoing regulatory compliance strategy development
- Creation and execution of comprehensive post market surveillance plan to collect market feedback
- DHF remediation to support legacy products
- MDR transition and CER updates for European CE Mark maintenance
- Cost effective outsourced but integrated regulatory and quality departments
Our top regulatory experts optimize submissions, ease filings and keep you moving ahead. ELEXES comprises some of the most experienced and adept minds with over 20 years of experience in providing solutions to keep Clients on course from scratch to the desired end. The conceptual framework and methodology we employ distinguishes us from other firms in the regulatory and quality management consulting fields.
Every project is dynamic. ELEXES has flexible operations to provide you with innovative and “out-of-the-box” ideas for any problem, small or big. We have been offering special consideration and flexibility for startups that need time to complete testing and helped get their systems in place for a successful filling.
High regard to confidentiality
We value Client’s confidentiality and ensure it’s kept intact at all times. We take care of this through the quality management systems that are in compliance to ISO 13485 standard, and by involving dedicated and sincere full time personnel.
Successful track record
With over 50 projects successfully delivered, we have an established track record, with a number of references. To help our Clients understand the regulatory and audit and inspection expectations, we have been consistently leveraging our learnings and experience with regulatory bodies like the FDA, Health Canada, Australian TGA, and European Notified Bodies like TUV, SGS, BSI, MedCert, UL, DQS, GMED, and others.
ELEXIANS are great listeners. Before inception of any project, we work with our Clients to cover every detail. A dedicated project manager will look after every step of the way throughout the project. Our team believes in being proactive as opposed to reactive. We foresee the big picture and can spot and correct areas of concern well before they become a problem. ELEXES believes that Clients, big or small, public or private, can benefit from an innovative platform through which sophisticated regulatory advice can be delivered cost-effectively without any compromise on quality and expertise.
Elexes Leadership Team
Leading: Best expertise in the services we offer
Integity: Trustworthiness and maintaining confidentiality
Focus: On precisely addressing client's requirements
Efficiency: Through collaboration via cloud based tools
Elexes Leadership Team possesses deep expertise and insights into the medical device, AI/ML based software, and IVD space. They support Clients in an advisory capacity and often act as the Regulatory or Quality Director.
Elexes Team comprises Biomedical Engineers, Microbiologists, Mechanical Engineers, Software Engineers, and personnel with interdisciplinary exposure which allows them to interface with the Client easily and help assist in achieving the end goal.
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