Quality Systems

Michael Kuchenreuther, PhD, is a research analyst, at Numerof & Associates, Inc.

Jill E. Sackman, PhD, is a senior consultant at Numerof & Associates, Inc. (NAI), St. Louis, MO, www.nai-consulting.com.

Articles

Biopharma companies should not overlook India's growing market.

India's Developing Market Offers Opportunities

How badly is Brazil's pharmaceutical market suffering from the global instability of emerging markets?

Global Instability Affects the Pharma Market in Brazil

China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.

Pharma Industry Corruption in China Under Scrutiny

In first official visit to India, FDA commissioner to discuss ongoing collaboration on drug programs.

FDA Commissioner to Meet with Indian Regulatory Authorities

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Some recent high-profile cases of quality issues at Indian manufacturers have given reason to examine manufacturers more closely.

The State of Drug Manufacturing in India

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

India has a name when it comes to generic drug development. According to a recent research on patent applications carried out by Withers & Rogers, innovation by Indian pharmaceutical companies has increased over the past few years; however, the quality did not match the standard seen in Europe.

Innovation on the Rise among Indian Pharmaceutical Companies

Brazil is the first Latin American country to emerge as a global biopharmaceutical collaborator.

Innovation and Market Growth in Brazil

Siegfried Schmitt, principal consultant at PAREXEL, discusses the state of drug manufacturing in India.

Drug Manufacturing Focus: Why India?

Mylan and the Indian biopharmaceutical company Biocon receive approval for a biosimilar version of trastuzumab in India. Also, Mylan and Teva reach settlement on Copaxone in the EU.

Mylan Receives Approval for Biosimilar in India; Reaches Settlement with Teva on Copaxone

New regulation offers patients in Brazil greater access to experimental drugs.

Regulatory/GMP Compliance, Emerging Markets