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About NDA Analytics
Regulatory Compliance
NDA Analytics operates in compliance with
UK, EU and US cGMP regulations. Our laboratories have a
long history of successful GMP inspections. The most recent
relevant GMP inspections are:
- January 2001 – UK MHRA (Medicines and Healthcare products
Regulatory Agency, previously MCA), no critical or major
findings.
- May 2002 – US FDA PAI, no Form 483 issued.
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Quality
Our Commitment to Delivering Quality Service:
- Our goal is to deliver an error-free product on time,
every time.
- We want to understand your requirements and expectations.
- We are committed to meeting or beating those expectations.
- Focus on establishing excellent communications and mutual
understanding.
- Our approach is to build in quality from the start.
- Quality control measures are applied throughout a project’s
lifetime.
- All studies comply with relevant ICH and GMP regulations.
Our QA department inspects our facilities,
systems and procedures frequently and audits all reports.
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Reporting
Our aim is to provide error-free reports
on time... every time!
Flexibility:
- Reports customised to your exact requirements in terms
of format, layout and style.
- Reports provided on your choice of media (e.g. hardcopy,
PDF on CD-ROM, editable Word documents for easy dissemination
into electronic submissions and/or delivery of results
via secure data or web link).
Speed:
- Same day advice of OOS / OOT results.
- Results typically provided within 3 days of analysis.
- QA-audited reports typically dispatched within 10 days
of analysis.
On time:
- 2002 – 100% of reports (116 in total) delivered on time
or early.
- 2001 – 97% of reports (109 in total) delivered on time
or early.
- 2000 – 93% of reports (89 in total) delivered on time
or early.
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