BUILDING A CULTURE OF SAFETY AND SAFETY PSYCHOLOGY WITHIN AN ORGANIZATION.

11 Nov 2020

Most of you are probably aware of the well-documented case of The Piper Alpha oil platform disaster of 1988, where absence of adequate maintenance and risk assessment led to the loss of 167 lives. Another major industrial accident, the catastrophi...

PARADIGM SHIFT: REMOTE AUDITS DURING THE COVID PANDEMIC

30 Sep 2020

Traditionally, most pharmaceutical companies have preferred to conduct on-site audits of their vendor partners. Seeing the partner’s facility in person and meeting the people who will be handling your product has be...

How to develop a successful regulatory partnership with a CDMO

31 Aug 2020

A CDMO plays a critical role in developing and finalizing the CMC section of your regulatory filing. An experienced and technically sound regulatory team at the CDMO is a valuable partner in ensuring a swift and seamless product approval by variou...

What does a pharmaceutical integrated services program entail? Key attributes to look for in an integrated services provider.

23 Jul 2020

 

As drug development gets ever more competitive, complex and costly, innovator and generic pharma companies are increasingly choosing contract development and manufacturing organizations (CDMOs) to streamlin...

Investigative Report Writing

13 Apr 2017

According to a report by the FDA (FY2010), the third most common reason for a 483 (violation) was because of inadequate content of investigations or not completing an investigation in a timely manner. One of the most common mistakes made by the write...

Our Facility Expanding With The Market

12 Jan 2017

According to recent trends in the market, the global contract pharmaceutical manufacturing industry is increasing at an average annual rate of 7.5% and is predicted to reach $79.24 billion in revenue by the year 2019. The market research firm, Vision...