FDA Regulatory: Pharmaceutical & Medical Devices

Jennifer Ahearn
Senior Managing Consultant
& Director of Pharmaceutical & Medical Device Sub-Practice
Phone: (678) 990-3280
jdahearn@engsys.com 

View Capability Sheet

Navigating the Complexities of the Regulatory Environment

Our regulatory group for pharmaceutical and medical devices partners with manufacturing quality teams to manage, mitigate, prevent, and resolve regulatory issues, enabling clients to maintain good manufacturing practices (GMP) while realizing gains in operational efficiency.

Our services span the full range of regulatory compliance activities, from FDA compliance audits through larger scope FDA 483 remediation activities. We have assisted manufacturers through FDA responses by providing data reviews and audits, writing investigations, mentoring on investigations, performing root cause analysis, assisting with gap assessments of STP/SOP and validation packages, and reviewing laboratory, manufacturing, and biologic quality control and quality assurance systems.

Industry Experience

Our regulatory team has deep, hands on experience working directly for the FDA and manufacturing companies, providing services that span the end-to-end manufacturing timeline, from pre-submission of pharmaceutical NDA/ANDA and medical device 510(k) applications to manufacturing, packaging and testing.  We also routinely assist quality units in solving and answering technical problems in manufacturing, laboratory and packing, and analysis of the materials supply chain. 

Selected Areas of Expertise

Pre-Approval Phase (Pre-Manufacturing)

  • cGMP and Regulatory Training
  • Clinical Trial Material Manufacturing & Testing Drafts
  • Reviews of SOP/STP Laboratory & Manufacturing Audits
  • NDA/ANDA Safety and Maintenance Procedure Evaluations
  • Pre-Approval Inspection and FDA Readiness Pilot to Full Scale Assessment Plans
  • Validation Data Integrity Evaluation
  • Vendor Qualification

FDA 483 Observations/Warning

  • Corrective Action Plans Training
  • Liaison to FDA Field and Headquarters
  • Laboratory Data Review and Release
  • Response  Strategies
  • Retrospective Review of Quality Records 
    Investigations Batch  Record  Review  and Release

cGMP Quality Manufacturing

  • Quality System Assessments
  • FDA Compliance Improvement Strategies / Preparation & Readiness
  • Mock cGMP and Pre-Approval Audits
  • International and Domestic Manufacturer Remediation Recommendations
  • Assessment of cGMP Operations (SOP and STP Gap Assessments)
  • cGMP System Inspections and Corrective Action Plans
  • Quality Assurance, Quality Control,
    Validation and cGMP
  • SOP/STP and Validation Protocol Development
  • Cleaning Validations / Sterile Manufacturing

Vendor Assessments

  • cGMP Audits for Pharmaceutical and  Medical Device Companies
  • Alternate Vendor Validation Plans
  • Critical Parameters for Vendor Materials
  • Materials Supply Chain Management Systems

We also offer a training in a broad range of regulatory and scientific areas, including FDA regulatory expectations, cGMP regulations for manufacturing and quality controls, and statistics practices. 

Pharmaceutical Manufacturing Investigations

ESI has extensive experience investigating root cause, analyzing deviations, and assisting pharmaceutical quality teams with decisions regarding product disposition. These investigations include all phases of the product material chain, including raw materials intake testing, bulk blend testing, finished product attributes, expanded AQL testing, and packaging.

Professionals in This Area

Name

 

Title

 

Email

 

Location(s)

Ahearn, David L., P.E.   Senior Consultant   dlahearn@engsys.com  

Georgia

Ahearn, Jennifer D.   Senior Managing Consultant and Director of Regulatory & Compliance-Pharmaceutical & Medical Devices   jdahearn@engsys.com  

Georgia

Bilancia, Louis F., P.E.   Senior Staff Consultant   lfbilancia@engsys.com  

Oregon

Pederson, David A.   Senior Consultant   dapederson@engsys.com  

Georgia