​​​​​​​​Pharma Engineering Services, Inc.​

About the Owner​ Andrea L. Stewart:

​​After years supporting pharmaceutical and medical device development programs across manufacturing, CMC, and commercialization initiatives, I founded Pharma Engineering Services, Inc. in 2015 to help organizations navigate complex development challenges efficiently and successfully.


Sample Products:

  • Combination products
  • Intravitreal products
  • Biologics & Biosimilars
  • Aerosol/inhalation products
  • Prefill syringes
  • Solid oral dosage
  • ​Anethesia products


Expertise:

  • Strategic Cross-functional Project Management​

  • Design Controls

  • Drug Product Development

  • Start-up support

  • FDA readiness

  • Vendor Management (CSPs & CMOs)

  • Regulatory Coordination


Why Clients Work With Me:

  • ​Deep CMC and manufacturing expertise​​

  • Cross-functional leadership from development through commercialization

  • ​Experience supporting startups through large organizations

  • Strong CMO and vendor management capabilities

  • FDA/PAI readiness experience

  • Ability to align technical and operational teams quickly