Regulatory Submissions and Compliance

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• Devise CMC strategies for drug and biologic development programs

• Develop, review and assess FDA submissions: IND, NDA, ANDA, PLA, DMF

• Interpret current FDA CMC regulatory guidelines, policy statements and trends that impact overall drug development strategies

• Identify contract facilities to carry out CMC development, Quality Control, and production tasks

• Provide expert regulatory advice on US label and labeling requirements for pharmaceuticals

• Perform quality and compliance assessments appropriate to every stage of drug development

• Identify drug manufacture and testing contractors to meet client needs

 

Quality Assurance and Control

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• Provide expert advice on all aspects of CMC Quality Assurance

• Review and write standard operating procedures (SOPs) to assist you in meeting relevant regulatory requirements

• Conduct training to support current Good Manufacturing Practices (cGMP) and compliance with CMC regulatory requirements

• Review protocols for method transfer, method validation, stability studies, and process validation

 

Contract Management

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• Identify reliable contract manufacturers for bulk drug, formulation development, drug product manufacture, and analytical services

• Provide expert advice on selecting identified contractors to ensure the highest quality and to avoid potentially costly manufacturing mistakes

• Coordinate and manage contractor activity and monitor progress

 

Business Development

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• Support new business development and technical operations with expert analysis of new CMC technical capabilities in drug development

• Perform technical and regulatory audits, technology assessments and due diligence evaluations, and support and conduct mock pre-approval inspections of client facilities for licensing, mergers, acquisitions, investments and litigation

• Assure that product performance claims are substantiated with technical data

• Provide confident evaluation of new technologies and expert advice on technology transfer and assessments

• Offer pragmatic advice on unconventional and frontier technologies