Home
Who we are
Who we are
Overview
Chairman's Profile
Board of Directors
Team Wockhardt
Collaborations / Partnerships
Faclities
Manufacturing
Contract Manufacturing
Virtual Tour
Global Presence
Our Footprints
Other websites
Community Care
Wockhardt Foundation
We touch lives
R & D
Overview
Generics
New Drug Discovery
Biotechnology
Overview
Biopharmaceuticals
Biotechnology Park
Gallery
Corporate Regulatory
Marketing & Regulatory Infrastructure
Products
Search Products
People
Frequently Asked Questions
Life at Wockhardt
Focus on Development
Wockhardt Anthem
Meet our People
Wockhardt on LinkedIn
Career Openings
Investors
Financials at a glance
Annual Reports
AGM Notice
Chairman's AGM Speeches
Other Shareholders Services
Quarterly Results
Financial Press Releases
Chairman's letter to Shareowners
Details of Unclaimed Dividend
Filings with Stock Exchange
Shareholding Pattern
Stock Quotes
Statutory Communication
Policies
Credit Rating
Investor Communication
Investor Meet
Investor Contact
Investor Call
Accounts of Subsidiaries
Media & Press
Media coverage
Press Release
Media Kit
Media Contact
CSR
CSR Policy
Report on CSR activities – Wockhardt Foundation
CSR Strategy
Quarterly Report
Stakeholders Engagement
Home
>
How we touch lives
>
Marketing & Regulatory Infrastructure
Marketing & Regulatory Infrastructure
With the global market for biogenerics getting bigger, wider and worth over a US$100 billion, we have set our sights to tap this business opportunity. And to this end, we have built comprehensive concept-to-market capabilities for biogenerics for the international markets.
A sound regulatory infrastructure has been set up for our biogenerics pipeline, with registrations in developing as well as developed markets, such as the US and Europe.
With a basket of recombinant brands, we are making forays into regulated, non-regulated and less regulated markets. We are also rapidly progressing with clinical trials in some of the developed countries, to tap future business opportunities.
Our expertise in Corporate Regulatory includes
Well experienced team for Global Regulatory Affairs for Drug Product and Drug Substance
Regulatory expertise available for US, Europe, Australia, Canada and Rest Of the World
Experienced and focused team for Biotechnology, New Chemical Entities and ANDA products
Experience in handling Pre-IND meetings for 505(b)(1) and 505(b)(2) applications with FDA and Scientific advisory meetings with European agencies
Capabilities for DMF, ASMF and CEP for the Active pharmaceutical ingredient (API)
Experienced in handling registrations for various dosage, forms such as Solid orals, Injectables, Ophthalmic, Liquid orals and Biotech products
Regulatory compliance in the manufacturing facilities approved by US FDA, UK MHRA, Brazil-ANVISA and other international regulatory agencies