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Consulting

 

 

Globepharm Consulting offers your company a range of services:

  • Cost-effective internal Quality/GMP compliance audits, litigation testimony and vendor/supplier inspections
    Mock-FDA PAI and GMP Inspections of biotechnology, diagnostics, pharmaceutical and API manufacturers
  • "Due Diligence" activities include inspections prior to company acquisitions
  • Quality/GMP Expert Testimony in court cases
  • QA and QC Systems Audits
    Supplier and Vendor audits
    Facility Design and Facility Design Critiques
  • Other GMP-related activities

Benefits of working with Globepharm

1.Bulk pharmaceutical chemical (API), pharmaceutical, biotechnology and medical device companies benefit when outsourcing QA audit activities to Globepharm Consulting

  • You gain world class expertise to any Quality/GMP standard you name (ISO-9000, EU GMPs, FDA cGMPs, MHRA GMPs, TGA GMPs), or to your own corporate standards.
    Strategizing to pass a regulatory inspection the first time through – guaranteed!
    Validation Master Planning and implementation.
    Rapid recovery from disastrous regulatory agency inspections.
    Over 50 full scale GMP audits performed annually – APIs, finished dosage contractors, device manufacturers, we know what to look for and how to effect change to improve operations. While not wasting time, clients tell us that we are extremely thorough.
    We perform many quality systems audits within companies to highlight departmental and system deficiencies and provide guidance for effective corrections.
    Having worked in 27 countries, we know the local cultures and have surmounted the difficulties to ensure useful and effective audits.
  • Constantly traveling within the Americas, Asia, Europe and the Middle East – we can significantly minimize your travel costs by sharing costs with other clients.
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2. Benefits for strategic partners
  • Priority date availability to perform the inspections you need, when you need them performed.
    Lower cost of travel – we are constantly traveling, so your travel costs are shared with others.
    Whether its Canada, China, India, Mexico, or anywhere else, we’ve been there, we know our way around; we know what the local norms are, and how far they are from the standards you require
    Effective internal company audits where company politics inhibit an effective audit independent, unbiased, objective Quality Assurance/GMP audits, guaranteed to successfully effect change – top management uses us to gain unbiased pictures of operations and the level of company regulatory risks; middle management uses us when top management is not getting the message.
  • We do not waste your time and money – our audits are thorough, time-effective and cost saving.

Ask us about our discounted strategic partner consulting rates.

 

 

 
 

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