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QUALITY AND REGULATORY

BPTC’s advanceONE services help you address the quality, regulatory, and compliance needs of your product and organization at all stages of development and commercialization. Whether you’re a virtual organization, late-stage development company approaching market approval, or a multi-national pharmaceutical company, our experienced team can:

  • Create a global CMC-regulatory strategy, identifying the critical regulatory requirements for your program, as well as outlining all product quality and process performance objectives within a specified budget and timeframe
  • Develop, implement, and manage phase-appropriate quality systems and functions, including preparation of the necessary standard operating procedures and related documents
  • Define your Target Product Profile (TPP) to identify critical attributes and communicate them to key stakeholders and regulators
  • Perform cGMP audits of your facilities or your selected CMO, testing laboratories, and raw material suppliers to ensure appropriate regulatory compliance
  • Prepare global regulatory submissions, including US INDs, NDAs, BLAs, and their foreign equivalents, using our proprietary CTD templates
  • Write, review, or edit development reports supporting process development, validation, manufacturing, and quality for inclusion in global regulatory filings
  • Provide quality assurance support, including serving as your virtual QA head, reviewing master and executed batch and testing records, reviewing and releasing products for clinical trials

TESTIMONIALS

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