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Regulatory: Clear your path from concept to candidate

Proven track record in regulatory support

Our track record for quality is proven with thorough compliance with the FDA, EMA, PMDA and other regulatory agencies and more than 550 API dossiers filed worldwide.

  • Global filing support
  • CMC module authoring (drug substance and drug product)
  • Certificate of Suitability (CEP) authoring and maintenance
  • Pre-IND and pre-NDA/ANDA meetings, Type C meetings, etc.
  • Consulting and deficiency management
  • Site registrations, U.S. Agent services
  • Publishing services (eCTD)
  • DEA registrations
  • DEA consulting
  • Quota requests
  • Determination requests
  • Researcher protocols
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Commercial products
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Proprietary DMFs across global markets
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Regulatory inspections pass in the last 5 years

Support

Whatever your complex API manufacturing journey looks like, our regulatory team is here to help you succeed.

Diverse Modalities

Diverse program experience across emerging and established modalities, such as mAbs and mRNA, demanding specialized and complex regulatory support.

Collaboration

Integrated teams between small molecule and biologics leveraging each other’s expertise and global regulatory authority relationships.

Generic APIs Insights

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Ready to realize your product’s full potential on your schedule?

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