Timothy Malloy, MS, RAC
Regulatory Affairs Consultant experienced in developing and implementing regulatory strategies for new registrations and marketed products on diverse cross-functional teams. Strong background in chemistry, pharmaceutical development, drug substance and drug product manufacturing, implementing complex post-approval changes, eCTD/metadata requirements and a current understanding of global regulatory requirements.
Timothy Malloy has more than 30 years of experience in the pharmaceutical industry, including the last 20+ years in regulatory affairs, has several patents in drug development, and is RAC Certified.
Services
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Provide guidance for API chemistry, pharmaceutical development, drug product manufacturing and controls throughout the life-cycle of the product
- Respond to HA inquiries, secure approvals and launch in global markets
- Provide strategies to implement complex post-approval changes, and secure the supply chain
- Familiar with eCTD/metadata requirements
- Authoring and reviewing Module 2 and Module 3 CMC sections for submission
Services
- Provide guidance in chemistry, pharmaceutical development, drug substance and drug product manufacturing and controls throughout the life-cycle
- Respond to HA inquiries, secure approvals and launch in global markets
- Provide strategies to implement complex post-approval changes and secure the supply chain
- Familiar with eCTD/metadata requirements
- Authoring and reviewing Module 2 and Module 3 CMC sections for submission to Health Authorities