We are pleased to announce that FDASmart Inc. is joining as a new, first-time member of DCAT starting November 2017. We wish to reach out to the DCAT corporate community and hope we can meet or at least interact with you all by the time DCAT 2018 rolls around in New York City!

FDASmart Inc. is a global pharmaceutical, biotech, medical devices US FDA regulatory and CRAMs/CMOs outsourcing China/India partnerships/ consulting entity assisting US companies with outsourced services business or new markets and business development for India, China and Middle East markets.

    Allow us to share some past notable FDASmart business endeavors that include:

    aSuccessful planning, delivery & management of an outsourced clinical data group assembled for the world's largest pharmaceutical company-Pfizer Inc. via the start-up presence established by FDASmart for this purpose in India during mid-1990s through its CEO- Ram Balani ( Pfizer Central Research, Groton, CT. USA-FDASmart as CRO to Pfizer Inc.)

    FDASmart created, staffed then managed entire operations in India, monitored deliverables between FDASmart India and Pfizer Central Research Clinical Research, Groton, CT.

    aEstablished a successful India-China market strategy in 2009 for Beijing based Reed Sinopharm Exhibits (RSE), China’s leading pharma conference organizer. Project culminated in increased market exposure for API industry in India and launch of SIPP- Sino-India Partnership Pavilion-SIPP original concept and SIPP program organized and hosted at API China in Xian and Chengdu trade show floors by FDASmart. http://www.fdasmart.com/fdasmart/apichina/API.pdf

    aFDASmart’s ALSO organizes, and hosts webinars, on-site networking events in the global pharmaceutical/biotech, CRAMs/CMOs and medical devices industry both in the US and India.

    Ram Balani, FDASmart CEO, has in fact participated in past speaking presentations at CPhi (Lunch time series), delivered webinars on topics including US FDA GMP in Emerging Regions (India-China),(Frankfurt, Germany 2011), etc. To view more speaking engagements,
    please see -- http://www.fdasmart.com/ram/pastspeaker.html

    To access CPhi Show Daily Feature on FDASmart Inc. click here: www.fdasmart.com/CphiFrankfurt2011/ShowDaily

    To access for FREE at no cost, the entire FDASmart Lunchtime series on “Pharmaceutical cGMP in Emerging Regions” (Perspectives from China and India) presentation by Ram Balani-CEO, FDASmart- click here: www.fdasmart.com/CphiFrankfurt2011/cGMPLunchtime

    aFDASmart presented a Poster Presentation in Philadelphia at the HPAPI Summit on the nascent HPAPI markets in India/China including key player HPAPI outsourcing partner companies in Asia that will surely competitively challenge Western HPAPI manufacturing in time as India/China has accomplished in the past with Asia’s (India/China) API & pharmaceutical finished dosage & generic drugs lower labor costs, technology transfer from the West partnerships, etc.

    To Access the FDASmart HPAPI Summit Poster Presentation with focus on China/India,
    please click: http://www.fdasmart.com/HPAPiIPhiladelphiaSummit.html

Immediate FUTURE developments-we wish to share with our new DCAT co-members:

There exist, without stating the obvious, a cultural & best practices divide between US/European companies and those in India/China. Truth be told—President Reagan’s iconic comments on “Trust but Verify” with Russia in the heart of the Cold War very much applies when doing business with China/India.

For the first time, FDASmart will be launching a series of seminars & networking events on East-West US & Indian/China pharmaceutical/CRAMs/CMO partnerships, Indian/Chinese vendor outsourcing best business practices (or lack thereof) and much more.

a Westerners outsourcing with Indian CRAMs /CMOs expecting Western best business practices standards and commercial deliverables on contracts (or not?)
a Western companies entering into Indian commercial contracts with India, i.e a contract with India is not always what it seems ! Beware. (** specially when dealing with an India-based HUF- Hindu Undivided Family ** that has majority shareholders corporate ownerships and management control to boot!) ( HUF=Hindu Undivided Family –India’s corporations are often majority owned by founding families though publicly trade in Indian stock exchanges and presumably in compliance with India’s government and corporate statutes BUT MAYBE NOT!)
a New Jersey legal jurisdiction on Indian/Chinese companies in the US—US companies can hail jurisdiction on India foreign companies with certain legal doctrines met. Alter-ego vs Agency Theory
a India’s common law legal system – India inherited the British common law legal system, so did the America-but THERE ARE DIFFERENCES, litigating in India is a whole different ball game
a Indian civil procedure code (CPC 1908)
a India’s Contract Act 1872 – a contract is a contract right ? It sometimes depends on which side of the ‘pond’ you’re on !
a India’s Companies Act 2013 (governs corporate oversight in India) – or it seems, Hindu Undivided Family majority shareholders of private even publicly traded companies subsumes all if not most the regulatory oversight in India, i.e. Indian interpretation of a contract vs US client may be FAR apart !
a New CBDT (CBDT is equivalent to US IRS) Place of Effective Management (POEM) policy for determining tax residence in India. There are  consequences for  US or European based companies that establishes a presence in India for tax residency determinations or for an Indian holding company with overseas located  US subsidiaries masquerading to be an independent wholly owned subsidiary company but in fact constitutes a piece of ONE SINGLE PARENT ENTITY in INDIA !
a Group of companies doctrine, Europe’s ‘qualified defacto company group theory), etc.

All the legal tracks mentioned above will feature real lawsuit case facts & actual public court records of a  New York based US  company vs an Indian holding company/CRAMs/CMO  in Gujarat, India for  breach of contract. Lawsuit was filed against the parent holding company in India and its wholly owned subsidiary in New Jersey.
Our seminars and  on-site networking presentations will feature ACTUAL public court case records  when appropriate to illustrate New Jersey  legal statutes, Indian applicable laws,  disputes in the  interpretation of what constitutes a valid binding contract in the US vs India,  the challenges of obtaining  US foreign jurisdiction on an  Indian company with subsidiary in New Jersey, India’s HUF abuses(Hindu Undivided Family –India’s corporations are often majority owned by founding families though publicly trade in Indian stock exchanges and presumably in compliance with India’s government and corporate statutes)

In the coming weeks, we will be sending DCAT members MORE INFORMATION on these new business development or alternatively you can visit our website at: www.fdasmart.com to check for updates.

On-site events in the US will be held at Edison, NJ while in India we will host ALL events in Mumbai. Webinars will be forthcoming and will feature India legal experts, outsourcing companies with actual experiences with India CRAMs, CMOs (good & bad!  Including take-away learning) etc.

We look forward to engaging with members of the DCAT corporate community soon and of course hope to meet many of you at DCAT 2018 in New York City by the ‘clock tower’!


GMP Services Consultant Emerging Services in India & China GCP Train by US FDA Reviewer
OTC - Generics & APIs Pharma Webinars & Conferences Mobile Healthcare Application Development
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