Services We Offer
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.