Our Services
Drug/Diagnostics Co-Development
Strategy
Advise pharma and/or diagnostics companies on their co-development strategies for incorporation of diagnostics into their early late phase clinical trials. Review protocols and documents in light of current regulations. Help companies prepare for and lead meetings with Health Authorities. Help to address HA feedback on regulatory documents. General clinical and regulatory support.
Medical and Technical Writing
Review and prepare documents for global regulatory filings
(US/EU/UK/APAC) including presubmissions as well as 510(k), De Novo, BDD, IND, NDA, BLA, MAA to name a few.
Keep Current with the changes in theglobal regulatory landscape for IVDs,CDx, LDT, MDR/IVDR, etc.
The global regulatory landscape continues to evolve as noted by the US LDT changes, the continuing IVDR/MDR updates in the EU, UKCA, IVD classification in the EU and US, etc. Deep dive into how these changes may impact your IVD/CDx and co-development strategy and programs.
Biobanking and Biorepository
Services
Assist companies with their biobanking and biorepository needs. Sample sourcing and acquisition, tracking, monitoring, etc.
Training
Provide general training as well as training specific to your company's needs, such as preparing for HA meetings, HA audits, general and specific requests for topics, etc.