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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Hot topics

BioVentures Consulting Limited can advise on the ‘hot topics’ and points of regulatory concern. Those which relate to product development include issues which may occur in purification steps, contaminants, including residual DNA and host proteins and substrates of animal origin, viral safety, bioassays, and the suitability of characterisation following manufacturing process changes, as well as storage conditions and stability.

So often in biological drug development it is the process which defines the product

Some of these items can be key topics for so-called "biosimilars" and in scale-up where changes to the manufacturing process could result in a different "heterogeneous" product.

So often in biological drug development it is the process which defines the product. These are area in which the expertise of BioVentures Consulting Limited can be used to support your product.

In addition, other ‘hot topics’ which BioVentures Consulting Limited may be called in to advise relate to areas such as personalised medicine, biomarkers (including oncology programmes), health technology assessment (HTA) and reimbursement, traceability and identification, and the impact on the new pharmacovigilance legislation.

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