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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.
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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