Consultancy
Consultancy Details
What is unique about BioAppsolutions consultancy services?
BioApp is rich in skilled resource with talent that is well respected in the industry with 90+ combined years of experience. We understand Pharma and CROs.
BioApp are experts in all aspects of quantitative bioanalysis, we have many years of bioanalytical experience and have managed numerous successful bioanalytical projects from two perspectives, Pharma and CRO. We have a vast range of bioanalytical experience from discovery and regulated pre-clinical bioanalysis right through to Phase III and post marketing clinical bioanalysis. We have several years experience in dealing with audits, we are considered knowledgeable by our peers in the industry and are often sought after for advice and guidance.
Services range from on-site (in lab) method development through to remote project management. BioApp are considered innovative by their peers and have retained the vital practical laboratory skills to remain current.
Consultancy services we offer include:
- Selection of the most appropriate CRO based on the scope of work and specific analytical requirements including all aspects relating the sourcing, fee negotiation, and subsequent project management
- Bioanalytical site qualification/due diligence audit
- Due Diligence Audits as Bioanalytical Subject Matter Experts (SME) for Mergers and Acquisitions
- Project management/oversight of bioanalysis for the following types of study:
- Method development studies
- Regulatory Validation studies
- Fit for purpose Scientific Validation studies
- Non-regulatory and regulatory Preclinical studies
- Clinical sample analysis: FTIH to Phase IV
- All aspects of biomarker analysis
- Toxicokinetic analysis
Consultancy would include comprehensive regulatory document review, audit review and laboratory inspections. Management of data transfers and reporting to meet the required standards and project time lines. Troubleshooting both technical-method related and regulatory.
Where specialised sample collection is key to successful bioanalysis input into and/or production of related documents (e.g. lab manual) also preparation and shipment of clinical kits can be provided.
Need help trying to achieve challenging bioanalytical targets – BioApp can provide end to end bioanalytical consultancy.