Quality & Regulatory

BioProcess Technology Consultants supports all of your quality and CMC regulatory requirements through the design and implementation of quality systems appropriate for the stage of your product. Our experienced consultants 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-driven operations, including drug substance and drug product manufacturing. We specialize in writing, reviewing and negotiating 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 lifecycle, we help facilitate the development of robust and compliant products and processes.

We have extensive experience in auditing suppliers, CMOs, and testing laboratories. Using our proprietary audit check list, we efficiently cover all aspects of cGMP compliance to identify issues and propose appropriate corrective actions. To help ensure that your staff is properly versed in technical, quality, and regulatory requirements, we provide in-house training in topics including GMP compliance, pre-approval inspection (PAI) readiness, and Quality by Design. Our training programs are customized to meet your needs and effectively provide your employees and management with the critical skills necessary to perform their jobs.

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 clone to clinic® and often even during later stages of development, 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 from clone to commercial®.

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

Our regulatory and quality expertise and services provide you with support and assistance to:

  • Design and implement phase-appropriate quality systems and SOPs
  • Perform cGMP compliance audits of manufacturing and testing laboratories
  • Prepare regulatory submissions including IND, BLA, or equivalent, and participate in meetings with FDA or other agencies
  • Coordinate process development, analytical development, manufacturing and comparability protocols to insure regulatory compliance
  • Provide cGMP training appropriate for your organization and stage of product development