Category: White Papers
MAKING THE CASE: The Imperative for Life Sciences Companies to Integrate Corporate Compliance and Quality Compliance
In its simplest form, quality is about making sure that the products offered by a company are safe, effective, and meet the requirements of the prevailing regulations around good manufacturing methods. Corporate Compliance is...
Read MoreReaching into Research and Development of a Supply Chain Strategy
Critical materials and suppliers are selected early in development. By the time Technology Transfer occurs for commercialization, it is often too late to make changes to these critical components without having to do additional...
Read MoreIssues for Device Combination Products
The development of medical device combination products convenience packages continues to present interesting technical and regulatory issues. Inclusion of pre-sterilized syringes and applicators as part of these products poses...
Read MoreBARDA and their Countermeasures Initiative
Last month was the PHEMCE conference in Washington DC which translated the governments approach to countermeasures production for the next decade or so. From the discussions it appears that BARDA will be placing a greater focus...
Read MorePharmaceutical Consultants-The Key to a Rapidly Changing Industry
When market conditions, and methods of manufacturing, testing, and technology remain virtually unchanged for long periods, companies within that industry generally manage quite well doing everything in-house. However, when an...
Read MoreLean Manufacturing and PAT – The Next Level For Pharma
In 2003 the FDA announced the Process Analytical Technology (PAT) initiative to “encourage the voluntary development and implementation of innovative pharmaceutical manufacturing and quality assurance.” This initiative was...
Read MoreLean Manufacturing Solves Drug Recalls and Bad Press
In 2009, drug recalls reached an unprecedented high of 1,748. These recalls are attributable, in large part, to outsourcing and indiscriminate cost cutting. Today, more recent drug recalls and the resulting bad press are forcing...
Read MorePharmaceutical Consulting and BMI’s 4th Quarter Update
Over the next five years, pharmaceutical consulting could be positioned to play an increasingly critical role, according to the latest estimates from the Business Monitor International’s Pharmaceuticals & Healthcare...
Read MoreLean Manufacturing for the Competitive Edge
Factors within the pharmaceutical industry have combined with economy-related issues to force pharmaceutical companies to seek new ways of maintaining or regaining their competitive edge. Increasing globalization, scarcity of...
Read MorePharmaceutical Consultants Broaden the Scope
It is a widely accepted fact that consultants assist companies by analyzing and assessing each individual situation and set of circumstances. Consultants then work with that company to design and implement appropriate programs,...
Read MoreThe Right Sequence for Lean Manufacturing Implementation
For a pharmaceutical manufacturer, implementing lean manufacturing can be a fairly seamless and efficient process. It can also be fraught with resistance, incorrect perceptions and end up only a partial implementation. The...
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Testimonial
Smart Pharmaceutical Consulting has made a major contribution to our manufacturing strategy and how we plan to operate our plant in the future.