Regulatory

Option One Life Science Consulting provides hands-on support for:

• Regulatory Strategy

• CMC due diligence for BD transactions

• CMC Strategy, including assistance with regulatory applications and eCTD publishing.

• CMC regulatory support (IND, NDA/BLA, agency interactions)

• Review of regulatory filings

• Support to internal regulatory teams;

These services are internally integrated with Compliance Professionals with a focus on:

• Quality management systems

• cGXP compliance audits and preapproval inspections

• Industry experience from previous careers.