Inna Demidova, head of regulatory affairs for Russia and CIS at ELC Group, looks at the upcoming regulatory requirements in the world’s fastest growing market.
Stephen Archer of Spring Partnerships looks back on months of M&A buzz in the pharma community, and examines whether the industry really stands to benefit from corporate buyouts.
The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued.
Testing testing: Diane Paskiet, director, scientific affairs, West Pharmaceutical Services explains how to understand risk from extractables and leachables (E&L) and the key quality considerations when designing E&L studies
