“ HPAPI Capable CMOs & CRAMS in Emerging Regions”
“ Here Comes India & China (Again) ?”

HPAPI Global Market Opportunity

Challenges to HPAPI Manufacturing

India/China & Future HPAPI

* High Potency drugs have become the “darling” for Big Pharma and MNCs globally.
* CMOs and CRAMs are following suit, i.e. gearing up to build new, sophisticated drug manufacturing that can handle the stringent demands of cytotoxic API manufacturing.
* Today, due to high investment costs, technology and process demands plus sophisticated containment ,that small club of CMOs are predominantly Western, but could India & China not be FAR behind? Although LOWER COST is not the sole reason for outsourcing manufacturing, it remains a BIG FACTOR in the process. China and India have the “home” advantage plus global growth in pharmaceutical markets are leaning towards serving emerging regions domestic markets.
* Will history repeat itself? (, i.e. India generics formulation take-over plus China’s Global API production dominance)

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

FDASmart Inc. is a US, New York based consulting and pharmaceutical services firm with offices India & presence in China, Latin America & Russia to follow.

FDASmart operates with Western business best practices while successfully able to navigate local business cultures, delivering actionable results in EMERGING (BRIC) regions.

Multi-service company that you can trust to:

Outsource GMP audits or Gap Assessments in emerging regions
Assist market intelligence or new business development in India
Assist with US FDA regulatory registrations, submissions for NDA, ANDA , DMFs and Medical Device applications
Source APIs or Generic Formulations & OTC drug from Indian pharmaceutical manufacturers we screen to GMP quality
Outsource mobile healthcare app development or assist you with US FDA medical devices draft guidance as they relate to mobile apps or 21 CFR Part 11 compliance
Assist you to create life-sciences partnerships or joint collaborations for SMEs between US and Emerging regions like India
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