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Regulatory Consulting 

Customized Consulting Services for Every Client and Product

Strategic leadership, advice and options analysis for products and projects.

Regulatory Chemistry, Manufacturing, & Controls (CMC) services are offered in the areas of Technical/Regulatory Writing and Regulatory CMC Consulting. Both areas offer world class technical and regulatory expertise and experience that represent an outstanding value proposition for our clients. We offer many services beyond the most common ones listed below, so let’s get together to explore scenarios and build your custom project plan!

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We apply a strong emphasis on health authority requirements and industry best practices. Some examples of our services include:

  • Agency meetings/interacts and preparations

  • Strategic review of development plans

  • Pre-approval inspections and preparation

  • Change control assessments

  • Reference Listed Drug (RLD) and Inactive Ingredients Guide (IIG) excipient reviews

  • Comparability studies

  • Commercial control strategies

  • Risk assessments

  • Process Performance Qualification (PPQ) and Continued Process Verification (CPV) guidance and assessment

  • Strategic review of Good Manufacturing Practice (GMP) and technical documentation, policies, and SOPs

  • Due diligence and gap analyses

  • Controlled correspondence

  • Strategic advice on regulatory advocacy and policy

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