Infrastructure
Today’s pharmaceutical and biotech companies are striving to reduce costs and maximize efficiencies, while simultaneously working to advance the core business as quickly as possible. Organizations must make decisions on the best way to deploy their limited resources and get the job done. The process looks different depending where you are on the company formation and evolution timeline. Early development mandates thin resourcing and efficiency, more developed and financed organizations usually allow for deeper functional coverage. Finding this balance and outlining key priorities are essential considerations to plan and grow your business.
Identifying a key subject matter expert to serve as a liaison between the service provider and client will ensure compliance to quality and regulatory systems. For the service provider, customer satisfaction and adherence to quality systems in this highly regulated industry are essential.
Facilities
Work to identify facility solutions that match company formation and desired burn rate. Create a safe and effective work environment. Work with external resources to maximize value.
Human Resources
Recruiting, job descriptions, payroll, benefits, legal and compliance, federal reporting, interviews and selection, performance assessment, compensation planning, resourcing and outsourcing where possible. Leadership and Talent Community development.
IT
Networking infrastructure, hardware, help desk, project management, Telephonics, applications development, project management, resourcing and outsourcing where possible
Legal and Compliance
Create legal organization, review all regulatory and clinical submissions, licensure, organization governance, compliance committee development, all SOP’s, Compliance handbooks, sales force compliance review and monitoring, field based interactions policies etc.