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Madden
Associates Limited - The Company
Sam Madden graduated in Biochemistry (Toxicology) from the University
of Surrey in 1978. She served on the Board of the British Institute
of Regulatory Affairs (BIRA) from 1986 until September 1999 with
six years as Treasurer. Madden Associates Ltd is a member of Eural,
a pan-European association of regulatory consultants offering
a variety of services across Europe.
Initially recruited by Sandoz Pharmaceuticals in 1979 to work
on the Review of Medicines, she also handled New Active Substances
(NAS), most notably cyclosporin, still one of the major products
for Novartis. During this time she also gained an MSc in Biopharmacy
in 1982 from Chelsea College London. She was promoted to Registration
Manager in 1984, ultimately responsible for a department of 12
staff handling all NAS from Phase I through to Phase IV, as well
as maintaining the older products. The UK department had significant
input and involvement with the Swiss head office on CPMP issues.
By 1988 she felt that she had built up a department that could
thrive without her, and left to join Abbott Laboratories Ltd as
the Regulatory Affairs Manager. This position was responsible
for all regulatory issues on devices, pharmaceuticals and nutritional
products in the UK, Eire and Export markets. There was also input
to head office in Chicago on CPMP matters and to the diagnostics
part of the company in the UK. However, this proved not to be
the broad challenge that Sam required, and in 1989 she started
Madden Associates as a freelance consultant.
In the first ten years of operation, projects for over 60 companies
were carried out. In addition to helping out Clinical Research
Organisations who do not have regulatory personnel, national companies
from France, the UK, America, Switzerland, Japan, Germany and
multi-nationals have been assisted. These include Alpha Therapeutics,
Armour, Asta Medica, Bayer, Bristol Myers Squibb, Dexcel, Marion
Merrell Dow, Masters International, Monmouth, Novartis, Pharma
Consulting GmbH, PPL, Tetra UK, Trinity Pharmaceuticals, Septodont,
SmithKline Beecham and Vitaline.
Whilst at Sandoz, Sam gained approval of the CTX for the first
monoclonal antibody to be studied in clinical trials in the UK;
this was followed some years later, as a consultant to PPL, with
first transgenic product to be submitted for clinical trial approval
in the UK.
Madden Associates Ltd is still building on the tradition of handling
innovative products, using a common sense approach to ensure that
documentation can be easily understood and thus easily and quickly
assessed by the Regulatory Authorities.
Close association with pharmacists, QPs, toxicologists, medically
qualified consultants in the pharmaceutical and devices fields,
statisticians, marketing consultants, clinical research monitors,
veterinary medical advisors etc allows advice in most areas to
be given in a prompt manner. If we can’t do it, we can usually
put you in touch with someone who can.
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Us
Address
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Madden Associates Ltd |
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Farncombe House,
Doulting ,
Shepton Mallet, |
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Somerset BA4 4RB, |
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UK |
| Tel. |
+44 1749 830588 |
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