Pharmaceutical & Biopharmaceutical
Pharmaceuticals and biopharmaceuticals are one of the most highly regulated sectors in industry, and rightfully so. Quality, safety and efficacy must be managed across the entire life cycle of a medicinal product, whether it is New Chemical Entity or a generic. Life changing mistakes that were made with products such as thalidomide and the human plasma derived Factor VIII, must never be made again.
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This means that companies can face significant challenges in understanding the diverse requirements of the USA FDA, the European Medicines Agency, the UK MHRA, and other regulatory agencies.
Business models in the pharmaceutical industry have shifted over the last two decades. A significant number of small companies developing products that are then licensed to ‘Big Pharma’, after they have been ‘de-risked’. This can mean a high regulatory burden and expense placed upon developers who do not possess the same level of resourcing as Big Pharma companies, who have entire departments working to identify, prioritise and address the significant requirements.
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Drug repurposing is another game changer. Companies may be investigating new indications for off-patent drugs that are well understood with considerable post-market safety data. Repurposing a drug successfully can mean securing protection to market for that new indication with excusive rights, and sometime for orphan indications. Such an approach can bring rewards for developers and patients alike, if the appropriate strategies with respect to intellectual property protection and regulatory compliance are taken.
InViva supports the pharmaceutical industry, in particular the growing company that needs flexible regulatory resourcing at the appropriate stage of development, be it project management, quality management or preparation and filing of Registration dossiers for submission to regulatory agencies.
Examples of what InViva can do include: perform documentation review prior to submission to reduce enquiries and rejection; provide preclinical and clinical overviews through literature search, published studies, articles from journals; produce expert reports on Quality, Pre-clinical and Clinical; prepare Summary of Product Characteristics (SmPC)
