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Quality And Regulatory


Pharmefex supports all of your quality and CMC regulatory requirements through the design and implementation of quality systems appropriate for the stage of your product. We can prepare and review standard operating procedures, phase-appropriate product specifications, and process or method qualification protocols. We also review batch records for all GMP operations, including drug substance and drug product manufacturing. We will write, review and negotiate Quality Agreements with your contractor(s) to ensure that they are comprehensive and protect your investment.  By ensuring that quality considerations are included throughout a product’s life cycle, we help facilitate the development of robust and compliant products and processes.

We have extensive experience in auditing suppliers, CMOs, and testing laboratories. We will efficiently cover all aspects of cGMP compliance to identify issues and propose appropriate corrective actions.

Developing an effective regulatory strategy that balances a company’s business goals, resources, and risk tolerance is one of the most important product development activities. Recognizing that CMC activities are on the critical path from start to finish, we can help you align your CMC regulatory strategy with your corporate strategy.  Early attention to regulatory strategy can help reduce regulatory risk and facilitate development to successfully meet your critical milestones as you move to commercialize your product(s).

As part of our regulatory services, we will prepare CMC sections for IND, BLA, and equivalent regulatory submissions worldwide. We assist with regulatory interfaces, meetings, and responses to regulatory requests from pre-IND to PAIs and post-approval changes.

What We Can Do For You

Whether you need our assistance to guide your staff in design, development and execution, or you need us to oversee and direct activities at CMOs and CROs,  we can help you in:

  • Design and implement phase-appropriate quality systems and SOPs

  • Perform cGMP compliance audits of manufacturing and testing laboratories

  • Prepare regulatory submissions including IND, BLA, comparability protocols and reports, or assist in meetings with FDA and other agencies

  • Coordinate process development, analytical development, manufacturing and comparability protocols to insure regulatory compliance

  • Conduct mock audits and inspections and help you prepare for an upcoming regulatory inspection, whether it is your pre-approval inspection, or for an already approved product

  • Conduct risk assessments on your product or process development, characterization or validation

  • Conduct root cause investigations and implement corrective and preventative actions

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