Magid-Haffner

Magid-Haffner Associates, Inc. provides the following services to clients:

Regulatory:

  • Conduct FDA/EMEA International GMP Compliance Audits for API, sterile and non-sterile drug products.
  • Submission of DMFs, ASMFs, INDs, ANDAs, NDAs and MAAs by our global associates.
  • Document Control System Assessments
  • Review & Preparation of eCTD (electronic Common Technical Document)
  • Review & Preparation of Drug Master Files (DMFs) and Active Substance Master Files (ASMFs)
  • Pre-approval Inspection Preparedness (PAI PREP) and Mock Inspections
  • Third Party Audits/Assessments / GAP Analysis (GMP/GLP/QSR/ISO)
  • Due Diligence Audits & Assessments
  • Project Management for on-site or remote client support

GXP Training

  • Full Service and Custom Training Programs from R&D to Commercialization, including New Employees through Executive Management Personnel, levels including the areas of:
    • Manufacturing
    • Quality Assurance
    • Regulatory Affairs
    • Quality Control

Manufacturing Support

  • Process development scale up and manufacturing oversight.
  • Validation and Qualification support including protocol development and execution for:
    • Facility, Utility & Equipment Validation and Review
    • Cleaning Validation
    • Process Validation
    • Computer Validation (21CFR Part 11)
  • Facility design, renovation, and construction management.
  • Process equipment selection, procurement, SOP development and training.
  • Assist with selection and qualification of Contract Manufacturing and Laboratory Organizations.