BOSTON--(BUSINESS WIRE)--With a bold, overarching mission to help organizations transform science into commercial success, Health Connexions recognized a significant gap holding back emerging science and technological advances from succeeding in the market: regulatory compliance and registrations. By partnering with a successful organization like FDASmart, with in-depth and proven expertise with the FDA, that gap has now been filled. When it comes to submitting regulatory registration and compliance submissions, and meeting US FDA regulatory compliance requirements for NDAs, ANDAs, GMP DMFs, and 510(k) medical devices, FDASmart has the knowledge and experience required to overcome this hurdle.
FDASmart’s original mandate was to help businesses from emerging markets, in particular BRIC countries (Brazil, Russia, India, China), succeed in the US. This work has now expanded to include helping companies in other markets, e.g., Japan, Europe, South America and South Africa. Often, businesses fail in the US market, not because their products or services are lacking in quality, but because they do not meet the US FDA regulatory compliance requirements or are not successful in their regulatory submissions.
Conversely, US-based companies, whether start-ups or mature companies, face daunting challenges with time zone, cultural, business practice and regulatory differences when trying to penetrate foreign markets such as Asia. Based on its extensive Asian connections acquired over the years, FDASmart also assists US companies with new markets or business development in Asia (India and China).
Meeting US FDA regulatory compliance, and successfully submitting registration applications for compliance, is often a daunting task for many scientists-turned-entrepreneur, and even for large companies who are trying to break into the US marketplace. With previous experience in major global healthcare companies such as Pfizer, GlaxoSmithKline and Forest Laboratories behind him, the CEO of FDASmart, Ram Balani, saw this as a major gap and took it upon himself to fill the shortfall in the market back in 2007. Balani was originally involved in the successful planning, delivery and management of a clinical data group assembled for the world's largest pharmaceutical company, Pfizer Inc., during the start-up of this initiative in India.
Today’s global pharmaceutical markets operate 24x7 across all time zones. This trend demands faster, better and often media-rich ways to communicate. In some cases, on-demand and real-time communication, traditionally accomplished with long distance travel, needs to be accomplished in new ways. FDASmart has also developed an ingenious solution to bridge this gap in time and distance with its SmartInspect. SmartInspect is a secure, Internet-based, 100% mobile, wearable & free-roaming audio and video two-way communication technology that allows for on-site inspections to be conducted remotely. On www.fdasmart.com, click SmartInspect for more information.
Fast-forward to today, and even the US government has recognized that behemoths like the FDA need to be modernized and reformed. Witness their bipartisan initiative, 21st Century Cures (http://energycommerce.house.gov/cures), to modernize organizations like the FDA. In fact, they just discussed their efforts to push legislation to speed up FDA approval of new drugs, medical devices and treatments (http://woodtv.com/2015/04/26/to-the-point-21st-century-cures/).
And here, through One Million Solutions in Health, John Norris, JD, MBA, Former Principal Deputy FDA Commissioner (2nd-in-Command) and COO of the US FDA and Former Harvard Faculty Member, has actually set out a Call for Reform of the FDA: http://www.onemillionsolutionsinhealth.org/the-need-for-several-types-of-fda-reforms-and-tools-to-implement-them/
“Emerging scientists worldwide have the solutions and products in place, but they fail in getting their documentation approved by the US FDA, or in meeting regulatory compliance requirements. We need to move our collective efforts into overdrive. Too many people suffer needlessly, or wait far too long for the next solution to get through the regulatory hurdles. It is our mandate, and the reason behind this partnership with FDASmart, to have the 21st century be the century of CURES and solutions,” Dawn Van Dam, President & CEO of Health Connexions has declared.
With its New York office as its base, FDASmart also has offices in India and China; Latin America and Russia are expected to host offices in the future. FDASmart specializes in providing the pharmaceutical sector and CRO industry the training and consulting support required for successful drug discovery and clinical research studies in the US.
FDASmart also provides a number of services to support US FDA regulatory compliance and registrations:
- On-site GMP audits and assessments, as well as remote, virtual cGMP audits with the SmartInspect technology and service
- Market intelligence and business development
- US FDA registrations and submissions for NDA, ANDA, GMP DMFs and medical device applications and the required submissions to meet US FDA regulatory compliance
- Mobile healthcare application development; guidance as it relates to following the US FDA regulatory compliance guidelines
- Forming collaborations for SMEs (Subject Matter Experts) between emerging markets (BRIC) and/or emerging science from any country, and the US
Ram Balani, CEO stated, “FDASmart has helped many pharmaceutical and biotechnology companies expand and grow in the US. Additionally, we have been pleased over the years to assist US-based companies, both big and small, with overseas market intelligence, expanding business development activities (including partnerships or channel development), and outsourcing, by enabling extended reach in emerging regions, without significant in-house investments.”
The Health Connexions™ vision is to transform science into commercial success. Health Connexions helps clients in the life sciences, health care and consumer health sectors by leveraging its extensive network and unique collaborative model in consulting, market research, technology evaluations and marketing communications services. Health Connexions also provides strategic advisory services for capital raising to fund new innovations, new opportunities, and the growth of established organizations. Visit www.healthconnexions.com.
FDASmart Inc. is a pharmaceutical, biotech and life sciences regulatory consulting, and global business development, company focused in the US and emerging regions, including India and China. FDASmart delivers US FDA regulatory & GMP services, new market intelligence, channel development, consulting and training services to the pharmaceutical and biotech industry in the US and Asia (India & China). FDASmart’s legacy includes the successful creation of Pfizer’s Central Research clinical data management group in India.