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IPA Consulting Services. - Regulatory & Compliance, Technical Documentation, Validation, Training Programs Suppliers  IPA Consulting Services. - Regulatory & Compliance, Technical Documentation, Validation, Training Programs Suppliers

Pharmaceutical Products & Services Pharmaceutical Products & Services

 

IPA Consulting Services

Regulatory & Compliance

  • Preparation for FDA Pre-approval inspections (PAIs)
  • Attendance at FDA meetings
  • Laboratory Control Systems, CLPs
  • GMP Auditing
  • Quality System development and implementation
  • Third Party Audit
  • Change Control / Revalidation Programs
  • DMF Review
  • Production systems and Controls
  • Packaging and Labeling

Technical Documentation

  • SOP, Protocol and Report Preparation
  • Validation Master Plan
  • INDs, NDAs and ANDAs Application
  • Annual Product Report

Validation

  • Computer Validation
  • 21 CFR Part 11 Compliance Evaluations and Remediation
  • Cleaning Validation
  • Process Validation
  • Analytical Methods Validation
  • Equipment Qualification
  • Utility Qualification

Training Programs

  • GMP Trainings and Quality Systems Regulations
  • Stability
  • CAPA
  • OOS

Consulting

IPA Consulting Services' team is made up of former FDA and TPD officials and accomplished scientific and technical industry leaders.

Our associates and affiliates are carefully selected based on their reputation, academic accomplishments, extensive technical skills and knowledge, global regulatory expertise, and their effective delivery.

IPA Consulting Services

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Address

IPA Consulting Services Address IPA Consulting Services
 

420 Highway 7 East, Box 82022
Richmond Hill, Ontario
Canada L4B 3K0

Tel. +1 416 410 7402
Fax +1 416 491 5810


  
 
 
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