Welcome to the March-April 2017 Edition of The Protocol Link Newsletter!
Read on to catch up on Noteworthy Links, read about our Company's newest Director, discover the latest Protocol Link White Paper,  and finish with a Word from Our Staff.
Noteworthy Links
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Protocol Link Welcomes a New Director!
Protocol Link is pleased to announce the appointment of David McGregor, Ph.D. as its Director. David is primarily responsible for leading, overseeing, and executing targeted company project activities while assisting the company senior leadership in growing the Protocol Link brand and expanding its client base and market share.

David brings 20 years of technical management and leadership experience in the pharmaceutical, biotechnology, and industrial chemical industries.  He has expertise in the areas of analytical chemistry, APIs, DMFs, regulatory affairs, CMC, manufacturing technologies, gap analysis, audits, QA, stage-gate processes, complex project management, and international modernization.

"David is coming to Protocol Link with a wealth of talent and capabilities as an accomplished leader. I am greatly looking forward to the amazing things that he will accomplish in his role as our newest Director," said Dipak Doshi, Chairman and CEO of Protocol Link. "Protocol Link has been successful because of the quality of the people that represent the firm."


EMA Proposes Development of New Guidelines on Quality Requirements for Combination Products

On February 16, 2017, the European Medicines Agency (EMA) released for public consultation a concept paper to develop a guideline for quality requirements of medicinal products containing a device component for delivery or use of the medicinal product, to be included in marketing authorization applications (MAAs).

A Protocol Link White Paper:
Complying with the Combination Product Regulations 

Combination product compliance has been a recent priority for the FDA, starting with the issuance of the cGMPs for Combination Products, 21 CFR Part 4 in 20131.  The final guidance for Current Good Manufacturing Practice Requirements for Combination Products was issued very recently on January 10, 2017.

A Word From Our Staff...
"In today's technology driven, management-centric, and heavily regulated industry work environments, companies frequently rely and call upon SMEs with Program Manager (PM) expertise to lead their mission critical projects. Ideally these are PMs that integrate effective project management tools, know how (and when) to utilize these tools, and have the skills to effectively collaborate and manage multi-disciplined cross functional teams. They recognize the need to maintain focus on the objective, to drive accountability, and to communicate constantly. I believe having the right mix of applied technical experience and Program Management skills is key to maximizing the potential success of any such project.

How many times in our career have we requested (or wished for) a professional with these skills to drive a key project/program to completion? Protocol Link and our SMEs understand the role of PM. During our assignments, we ensure these key tools and skills are applied and properly fit the needs of each engagement. Over my 15 years with the company, if I had to pick a primary factor behind Protocol Link's 850+ successfully delivered projects to-date, PM effectiveness would be that factor. It has provided a consistent, winning value proposition by freeing up our client's key resources to focus on what they do best while navigating the most efficient, cost-effective path to the end objective. We invite you to explore our expertise in this space as you assess your current and upcoming program challenges."

- Ankit Patel
Director--Protocol Link, Inc.
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