Navigation Links
Greg Coulter, PhD, CMC Pharmaceutical Development Executive, Joins NDA Partners as Expert Consultant
Date:3/2/2017

NDA Partners Chairman Carl Peck, MD, announced today that Greg Coulter, PhD, a pharmaceutical development executive with more than twenty years of experience in GLP, GMP, and GCP regulated drug development and manufacturing has joined the company as an Expert Consultant. He has extensive experience in drug substance characterization, drug product formulation, manufacturing scale-up, regulatory compliance, quality assurance, and CMC regulatory writing, and is a specialist in development of liquid and solid oral formulations, liquid and lyophilized injectable formulations, and clinical supplies manufacturing. During his professional career, Dr. Coulter has provided operational and regulatory CMC guidance for virtual, start-up, development stage, and commercial organizations.

Dr. Coulter was formerly the Director of Formulations and Analytical Services at SNBL USA, Ltd.; Manager, cGMP Manufacturing at Cell Therapeutics, Inc.; Senior Process Chemist at Synthetech Inc.; and President of CTM Solutions, LLC. He is an experienced program manager and has planned and led the construction, equipping, hiring, and expansion of two GLP-compliant laboratories for a global CRO.

“Dr. Coulter’s extensive experience in drug product formulation, process development, scale-up, and manufacturing, along with his expertise in clinical packaging, labeling, and distribution logistics for global clinical trials, make him an excellent addition to our Expert Consultant team,” said Dr. David Savello, Partner and Manager, Product Quality & CMC Practice. “We are pleased to welcome him to NDA Partners and introduce him to our clients.”

Dr. Coulter earned his PhD in Biological Chemistry and MSc in Organic Chemistry from University of Guelph, Canada, and his BSc, Hon. in Biochemistry from Bishop’s University, Canada.    

About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.

Contact
Earle Martin, Chief Executive Officer
Office: 540-738-2550
MartinEarle(at)ndapartners.com

Read the full story at http://www.prweb.com/releases/2017/03/prweb14108309.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related biology technology :

1. Global Molecular Diagnostics Market 2016: Latest Instrumentation and Strategic Profiles of Leading Suppliers - Abbott, Beckman Coulter, BD, Bio-Rad, Gen-Probe, Tecan & Trinity Biotech
2. Former Allergan Chief David Pyott Signs on as Special Advisor to Sienna Biopharmaceuticals
3. AcelRx Pharmaceuticals New Drug Application for DSUVIA Accepted for Filing with PDUFA Date of October 12, 2017
4. Provectus Biopharmaceuticals Provides Information On Rights Offering Deadline
5. FACIT-Seeded Fusion Pharmaceuticals Closes US$25M Series A Led by Johnson & Johnson Innovation
6. OncoGenex Pharmaceuticals, Inc. Announces Phase 2 Apatorsen Data for Two Clinical Trials Presented at the American Society of Clinical Oncology (ASCO) 2017 Genitourinary Cancers Symposium
7. Vanda Pharmaceuticals Reports Fourth Quarter 2016 and Full Year 2016 Financial Results
8. Innovate Biopharmaceuticals, Targeting Celiac Disease And Ulcerative Colitis, presenting at BIO CEO & Investor Conference
9. Cocoon Biotech Announces Partnership with Camargo Pharmaceutical Services for Development Programs
10. Important Best Practices that Support Research and Development in Drug Discovery by Improving Decision-Making Efficiency for the Pharmaceutical and Biotech Industries
11. Incorporating Safety Pharmacology Endpoints in Toxicology Studies: Transposing the Experience with Biopharmaceuticals Into Small Molecules
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2017)... CA (PRWEB) , ... May 19, 2017 , ... ... annual meeting and educational conference of the American Association of Bioanalysts (AAB) and ... Galleria Hotel in Houston. The conference reinforces AAB’s commitment to excellence in clinical ...
(Date:5/18/2017)... (PRWEB) , ... May 18, 2017 , ... ... procedure on April 28, 2017 at the Prince Of Wales Private Hospital. The ... disc at level C6-C7. The patient failed conservative treatments prior to undergoing surgery. ...
(Date:5/18/2017)... ... May 17, 2017 , ... ... expertise, and further enhances its scientific power by providing investigators access to ... has agreed to join the scientific advisory board. “We are committed to ...
(Date:5/18/2017)... ... 17, 2017 , ... G-CON Manufacturing, Inc., the leader in ... Jornitz, was recognized as a Top 10 Industry Influencer on The Medicine Maker’s ... bettering the pharma industry and bringing life-changing medicines to market” across four categories. ...
Breaking Biology Technology:
(Date:4/5/2017)... , April 4, 2017 KEY FINDINGS ... anticipated to expand at a CAGR of 25.76% during ... diseases is the primary factor for the growth of ... report: https://www.reportbuyer.com/product/4807905/ MARKET INSIGHTS The global ... product, technology, application, and geography. The stem cell market ...
(Date:3/30/2017)... 30, 2017 The research team of The ... (3D) fingerprint identification by adopting ground breaking 3D fingerprint minutiae recovery ... of speed and accuracy for use in identification, crime investigation, immigration ... ... A research team ...
(Date:3/27/2017)... , March 27, 2017  Catholic Health Services ... Management Systems Society (HIMSS) Analytics for achieving Stage ... Model sm . In addition, CHS previously earned ... hospitals using an electronic medical record (EMR). ... high level of EMR usage in an outpatient ...
Breaking Biology News(10 mins):