Regulatory Services

Our Regulatory Group is here to support your product's compliance needs including:

•Audit Oversight

•Regulatory Inspections (FDA, EMA, MHRA, ANVISA, etc.)

•Client cGMP Audits

•Coordinates and provides responses to any observations issued by Regulatory or Clients

•Conducts Internal Systems Audits 

•Conducts External Audits 

•Supports Regulatory filings with clients

•Provides CMC review prior to submissions

•Write CMC Section for client submissions

•Conducts Internal PAI Readiness Inspections and gap analysis

•Conducts Regulatory Guidance Reviews