Quality Systems

Articles

The company’s new UV-1900 UV-VIS spectrophotometer incorporates features that improve usability, regulatory compliance, and performance.

Shimadzu's New Spectrophotometer Enhances Usability, Performance, and Compliance

CPhI released the findings of the 2017 India Pharma Market Report, which identified a two-tier manufacturing market and forecasted increased acquisitions by Indian companies, along with a significant improvement in the international reputation of Indian-made pharmaceuticals.

CPhI India Report Finds Two-Tier Manufacturing Market, Predicts Increased Acquisitions

The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.


China Joins ICH Global Harmonization Efforts

The three regulatory agencies have agreed to data requirements for development of new antibiotics.


Europe, Japan, and US Align on Antibiotics

The agency met with the representatives of the East African Community to discuss the creation of a networking agency.


EMA Builds Collaboration with African Regulators

The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.

Global Regulators Collaborate to Improve Access to Safe Drugs

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

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.

Covering Global Regulations in a Quality System

Domestic sales will be the key driver of revenue growth.

Indian Pharma Expects 30% Growth in 2017

FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.

Regulatory/GMP Compliance, Emerging Markets