Our Services

Regulatory Submissions and Compliance

  • 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

  • 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

  • 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

  • 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

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...it's time to call the experts