Navigate this site | | Our Experience....Your Solutions |
|
|
| |
Services Offered
DeGraft-Johnson & Associates LLC
Global Regulatory Consultants to the Pharmaceutical, Device & Biotechnology Industries.
Associates in Europe and Canada.
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.
• Preparation of Submissions Using the Common Technical Document (CTD) Including Summaries and Other Country Specific Formats.
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 &
Raw Materials.
• Scientific and Regulatory Guidance on Chemistry, Manufacturing, & Control (CMC)
• 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 Global Agency Meetings Including Development of Proactive Strategies for Negotiating and Resolving CMC Issues with Agencies (e.g. Background/Briefing Documents, Pre-IND, Pre-NDA, EOPII CMC Meetings etc.).
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.
 |
|
