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Products
& Services
 |
Services offered |
| |
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Preparation of clinical
trial submissions for the UK and Ireland. |
|
Regulatory advice at all stages of the
development programme. |
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Preparation and submission of dossiers
for human (ethical and consumer) and veterinary medicines,
including herbal and biotechnological products. |
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Preparation of drug and site master files. |
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Preparation of all labelling components
and SPCs to comply with the European requirements. |
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Advice on European regulations affecting the healthcare
industry. |
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Close liaison with the UK and Irish Licensing Authorities. |
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Improvement of your professional image with the Licensing
Authorities. |
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Advice on promotional copy and labelling issues. |
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Appraisal of products for inward or outward licensing. |
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Regulatory due diligence. |
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Practical advice on setting up or improvements within
a regulatory department: people, projects, procedures,
systems. |
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Training of regulatory personnel for improved effectiveness. |
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Training of other personnel on the role of the regulatory
function. |
|
Assistance where projects clash, during recruitment
or staff shortages. |
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Adverse drug reaction collation and reporting to
the Licensing Authorities. |
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Medical information cover. |
|
Preparation and submission of renewals, variations
etc. |
|
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Experienced
in the areas of: |
| |
|
Biotechnology, including monoclonal antibodies,
GMOs and transgenics. |
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Blood products. |
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Gastro-intestinal. |
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Cardiovascular. |
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Respiratory. |
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CNS. |
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Infections including antivirals, antifungals and antibiotics. |
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Dermatology. |
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Endocrinology. |
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Obstetrics and gynaecology. |
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Neoplasia. |
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Immunology. |
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Allergy including topical and systemic
formulations. |
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Nutrition. |
|
Musculoskeletal including topical and
systemic formulations. |
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Anaesthesia. |
|
Contrast media. |
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Generics. |
|
Countries where submissions have been made include Africa, Austria,
Cyprus, Denmark, France, Germany, Greece, Ireland, Middle East,
Eastern Europe, South Africa, Sweden, Turkey and the UK.
This broad range of experience has imparted the ability to pick
up new areas of expertise very rapidly, whether in company structure
or scientific discipline.
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Sub Menu
About
Us
Contact
Us
Address
|
Madden Associates Ltd |
| |
Farncombe House,
Doulting ,
Shepton Mallet, |
| |
Somerset BA4 4RB, |
| |
UK |
| Tel. |
+44 1749 830588 |
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