Chemical Consultants Network
Listing for
Damaris DeGraft-Johnson
Damaris DeGraft-Johnson
DJA Global Pharma, LLC
115 Commons Ct.
Chadds Ford, PA 19317
Phone:
(610) 558-4454
FAX:
(610) 558-4491
Web Page:
www.djaglobalpharma.com
E-mail: ddj@djaglobalpharma.com
SPECIALTY:
- Regulatory Affairs
- Pharmaceutical
Prior to founding DJA, Damaris DeGraft-Johnson was Senior Director and head of the Worldwide Regulatory Affairs
CMC Group at DuPont Pharmaceuticals Company/Bristol-Myers Squibb Company. She also has extensive global
regulatory and pharmaceutical development experience from Aventis (formerly Rhone-Poulenc Rorer) and Merck & Co. Inc.
Damaris has over 15 years of global regulatory expertise and over 20 years experience in drug development and
manufacturing.
SERVICES
- Global Regulatory Document Preparation & Maintenance
- US, EU & Canadian DMFs, INDs, NDAs, ANDAs, MAAs, NDSs, Amendments and Variations.
- Global Regulatory Guidance for Ensuring Timely Approval of Clinical Trial and Marketing Applications.
- Global Regulatory Agents for Various Products and Intermediates.
- Global Regulatory Strategy Development & Agency Meetings
Scientific & Regulatory Guidance on Development and Registration Issues.
- Preparation for Global Agency Meetings.
- Resolution of Issues Relating to Drug Substance, Drug Product, Excipients & Other Raw Materials.
- Development & Implementation of Global Strategies for Addressing TSE/BSE Issues.
- Development & Implementation of Internal Compliance Systems/Processes.
- Scientific & Regulatory Assessment of Information for In-license Compounds.
- Preparation for FDA & EU Agency Inspections
- -Preparation for Pre-Approval Inspections.
- cGMP, GLP and GCP Guidance and Implementation.
- Training
- Customized Global Regulatory In-house Workshops, Seminars and Training Courses.
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