Chemistry, Manufacturing, & Controls
Regulatory Consulting and Technical Writing
Our world-class scientists and regulatory experts can guide your product from inception to bedside and through the many technical and regulatory development hurdles along the way. We apply our knowledge of health authority requirements, technical acumen, and industry best practices to prepare technical and regulatory documents that are fit for purpose, scientifically sound, and aligned with agency requirements. Please see our most common services below and reach out to explore how we can best support your team!
Technical Services
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GxP documentation (for example, batch records, SOPs, protocols, reports)
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Deviation investigations
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Compliance gap assessment
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Strategic review of development plans
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Pre-approval inspections and readiness
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Comparability studies
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Commercial control strategies
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Risk assessments
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PPQ and CPV master plans, protocols,
and reports
Regulatory Services
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IND, IMPD, and clinical trial applications
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License applications: BLA, NDA, MAA
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DSURs, annual reports
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DMFs
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Post-approval supplements
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DEA Quota requests
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Agency meeting requests, briefing books, and interactions
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Responses to agency information requests,clinical holds, and complete response letters
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Change control assessments
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RLD and IIG excipient reviews
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Due diligence and gap analyses
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Controlled correspondence
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Regulatory advocacy and policy
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Orphan Drug and Breakthrough Therapy applications