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Scientific Update LLP Consulting Services are tailored to meet each customer’s specific needs and are completely flexible, both in terms of the project structure and payment arrangements. We prefer active involvement in the project and like to be involved as part of the team, with regular contact by the most appropriate means (eg telephone, e-mail or face-to-face).
Our consultancies vary from one-off events, often involving urgent trouble shooting to overcome a supply failure, through regular monthly or quarterly visits or advisory board meetings, to weekly or sometimes daily involvement in the detailed project discussions. The latter is particularly useful for small emerging companies and biotechs, where in-house resources are limited.
Often the discussion begins with consultation on the design of the chemistry for making 100s of grams or a kilo of new substance, when choice of route and CRO may be critical. Where a route is not suitable, we assist by identifying a suitable CRO for the route scouting and/or development chemistry. We have audited CROs and CMOs for clients. See also our Project Management page
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We are happy to discuss your needs:
• Small or large problems
• Intermediates or final products
• Early or late stage Click here to visit our Consultants' contact page
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Scientific Update Consultants keep up to date with Contract Research and Manufacturing Organisations (CROs and CMOs) by attending international exhibitions such as CPhI, Chemspec and Informex and have a unique knowledge of the worldwide picture including India and China. In addition, through our own conferences, companies come to us to exhibit. We have advised clients on the choice of partner appropriate for the stage of the project; we have current projects involving CROs/ CMOs in USA, UK, rest of Europe, India, China, and Australasia.
Our audits are rigorous and broad, not restricted to regulatory issues, but also focus on the ability of the CRO to carry out the work efficiently, safely, to desired timelines and within budget. A key aspect of this is an assessment of the quality and technical ability of the personnel involved, crucial for early development projects.
Using our collective experience of over 90 years in industry, we review proposals and where appropriate conduct site visits to ensure the deliverables are realistic and technical challenges appropriately judged to guard against mis-guided (over optimistic) expectations and the resultant disappointment.
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Our consultants have worked both as the CRO/CMO provider and the purchasing client, so know both sides of the supply chain very well.
A key aspect of our work is to provide a conduit between client and CRO or CMO to ensure the deliverables are realistic and technical challenges appropriately judged to guard against mis-guided (over) expectations and the resultant disappointment. We work with clients world-wide, across different time-zones and cultures, with the common theme to define a realistic cost and time structure then delivery in accord with the time-lines.
Scientific Update has successfully facilitated the progression of projects from gram scale (discovery chemistry) to kilogram scale in development and tonne scale in commercial manufacture. This includes the preparation of the drug substance chemistry, manufacturing and controls (CMC) sections of regulatory dossiers, as well as dealing with the GMP, QC and QA issues that arise along the way.
Expert advice relating to the overall strategic management of drug development programmes is offered.
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For due diligence or investment opportunitiesWe have worked closely with investment banks to examine CMC packages, usually from small biotechs, as part of due diligence activities and recommend, via detailed written reports, whether the investment opportunity is sound, whether there are potential showstoppers, and identify other reasons why the investment should or should not be pursued.
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Scientific Update has successfully facilitated the progression of projects from gram scale (discovery chemistry) to kilogram scale in development and tonne scale in commercial manufacture. This includes the preparation of the drug substance Chemistry, Manufacturing and Controls (CMC) sections of regulatory dossiers, as well as dealing with the GMP, QC and QA issues. Through our associates, we have also provided expert guidance and project management for formulation and secondary manufacturing.
Expert advice relating to the overall strategic management of drug development programmes is offered.
A key aspect of our work is to provide a conduit between client and CRO or CMO to ensure the deliverables are realistic and technical challenges appropriately judged to guard against mis-guided (over) expectations and the resultant disappointment. We work with clients world-wide, across different time-zones and cultures, with the common theme to define a realistic cost and time structure then delivery in accord with the time-lines.
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The selection of appropriate CROs and CMOs and effective cost control and realistic timeline management during the development programme is essential. These key services provided by Scientific Update can not only assist you in developing your drug in a faster more efficient way but can save you money as well!
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Scientific Update Consulting has, over the last 11 years, been involved as expert witnesses in many court cases (in the US, UK, continental Europe, Asia and Australia) involving patent disputes, mostly between major multinational pharmaceutical companies and generics. The consultants have been appointed as independent witnesses for a number of legal trials in Europe, North American and Asia specifically in cases involving process chemistry, crystallisation and polymoprhism and related issues. Often it is the multinational pharmaceutical companies that are trying to hold on to exclusivity for their blockbuster patents or to extend the patent life by use of ‘innovative’ process patents or novel solid drug forms. In contrast, the generics are seeking to circumvent these patents, though they also usually make counterclaims regarding validity, often with reasonable justification. For further information read this article... If you have a legal dispute and would be interested in seeking assistance, please contact Scientific Update today, for a completely confidential discussion . Alternatively, use this web site's contact form to contact one of the consultants directly.
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Services