YBCA




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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:

  • Support in the design of early development strategies to build product value quickly for those companies seeking further investment or development partnerships
  • Identification, selection and management of appropriate resources from the ever-expanding array of outsourcing services to complement the client’s own capabilities
  • Guidance on the critical steps from lead candidate optimisation to the non-clinical risk assessments for Proof of Concept studies in human subjects
  • Expertise in specialist fields including would healing, drug/device combinations, ADME, inhalation and reproductive toxicology, as well as the critical field of Quality Assurance
  • 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
  • Guidance and support in the preparation for and management of technical due diligence meetings with potential partners and funding bodies
  • Training in areas related to early stage pharmaceutical development
  • Auditing of quality systems and other processes to meet compliance with relevant regulations