| PHARMACEUTICALS
YBCA provides a comprehensive range of services in support of the
development of new products and in the lifecycle management of
existing products. YBCA
consultants have extensive experience in the major scientific and
regulatory fields required to develop a new pharmaceutical.
We can bolster your in-house resource at times of peak workload
or help you to defer the recruitment of specialists.
We can assist you with:
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Support in the design of early development strategies to build
product value quickly for those companies seeking further
investment or development partnerships
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Identification, selection and management of appropriate resources
from the ever-expanding array of outsourcing services to
complement the client’s own capabilities
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Guidance on the critical steps from lead candidate optimisation to
the non-clinical risk assessments for Proof of Concept studies in
human subjects
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Expertise in specialist fields including would healing,
drug/device combinations, ADME, inhalation and reproductive
toxicology, as well as the critical field of Quality Assurance
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Support in preparation of regulatory documents, such as the Common
Technical Document, and in the preparation for and management of
scientific advisory meetings with regulatory agencies
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Guidance and support in the preparation for and management of
technical due diligence meetings with potential partners and
funding bodies
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Training in areas related to early stage pharmaceutical
development
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Auditing of quality systems and other processes to meet compliance
with relevant regulations
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