Newsletters

Yes, Virginia, you ARE ready for eCTD!

Yes, Virginia, you ARE ready for eCTD!

It is my pleasure to introduce you to one of our “newest” members of the McCormick LifeScience team!  Nannette Hayes, RAC, has 12 years of Regulatory experience and holds her RAC certification.  She has operations and strategy experience working on trials conducted in the US and OUS (Canada, UK, Bulgaria, Czech Republic, Australia, Brazil, Colombia, Argentina, etc.) in Phases 1-3 with a special interest in working with controlled substances in clinical studies. Nannette also has experience with the preparation of several NDAs and post-market requirements. Always a team player, Nannette possesses a great work ethic, sense of humor and dynamic personality!

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GLPs… Assuring Data Quality

Can you remember back in our good ole’ school days (no, I’m not implying you’re old!) doing those long, drawn out math problems where we had to show every step prior to getting the answer?! The pain, the pain, the pain.

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You Think You Need a Medical Writer?

Please allow me to introduce one of the newest members of our McCormick LifeScience crew who has simply added levels of experience (and humor!) to our great team!  Lauren Agnotti, is a medical writer with over 10 years of experience, spanning trade journal articles and NDA submissions. She does not LARP (live action role play), and last wrote poetry in middle school. 😉 

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Who Needs a Pathologist?!

I’d like to introduce a member of our McCormick LifeScience team, Elizabeth Preisinger, MD trained in pathology at Brigham and Women’s Hospital, Harvard Medical School, and in molecular biology and genetics at Massachusetts Institute of Technology.  She has clinical experience in community pathology at Lowell General Hospital and at the Veterans Administration.

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Building & Maintaining a Relationship with Regulatory Authorities

(or any Regulatory Agency for that matter!)

I once learned from a very awesome colleague of mine (not to mention any names, but Michael Katz of Blue Penguin Development, small business marketing guru!), to “Stay in front of the people you know, over and over again, in a way that positions you as a likeable expert.”

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Yes, Virginia, you ARE ready for eCTD!

Yes, Virginia, you ARE ready for eCTD!

It is my pleasure to introduce you to one of our “newest” members of the McCormick LifeScience team!  Nannette Hayes, RAC, has 12 years of Regulatory experience and holds her RAC certification.  She has operations and strategy experience working on trials conducted in the US and OUS (Canada, UK, Bulgaria, Czech Republic, Australia, Brazil, Colombia, Argentina, etc.) in Phases 1-3 with a special interest in working with controlled substances in clinical studies. Nannette also has experience with the preparation of several NDAs and post-market requirements. Always a team player, Nannette possesses a great work ethic, sense of humor and dynamic personality!

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Shortcuts to Receiving Market Approval

13Think waaaaaaaaaaaaay (haha) back…growing up, did you ever try and take shortcuts when doing your homework? Perhaps reading the cliff notes for a book instead of the actual book you were assigned?!? Sound familiar? Eh…hem…we all took shortcuts at some point! The problem was…those shortcuts typically didn’t work…we probably ended up in a situation where our developing minds were missing important information that was needed for question number 1 on a final exam! Sweaty palms for the rest of the exam…

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What is it to be overwhelmed?

I would like to welcome back, Heather S. Duffy, JD PhD, a career scientist of over 20 years, who’s been a fabulous member of the MLC team!

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“GSP” – Good Submission Practices!

I’d like to introduce Lisa D’Attanasio, part of our McCormick LifeScience family for the last 3 years!  Lisa has over 20 years of experience working in the pharmaceutical industry.  Her career started in Quality Assurance before moving into Regulatory Affairs.  For the last 15 years she’s worked in Regulatory Project/Submission Management for both small and large companies in the Cambridge area.  To date she’s notched 1 eNDA, 2 NDAs, 1 BLA, and 1 MAA on her CTD Submission Tool Belt.

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Preparing for Meetings with the Food and Drug Administration (FDA)

So really, how do you prepare for meetings with the FDA? They can be quite intimidating, especially for new companies developing a relationship with the FDA for the first time.  Who knows what they need to hear?  Who knows what they will ask?  Do we wing it or do we prepare? Can we prepare?  How would we prepare?

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