INNOVATION AND COMPLIANCE CONSULTING

Solutions2Projects provides IT compliance and strategy services for biotech, medical device, diagnostic, and digital health companies. We help life sciences companies align technology roadmaps with corporate objectives and meet IT compliance requirements in a complex and regulated industry.

As the consultant’s consultant, we are well positioned to provide targeted assistance to your consulting clients for new or existing IT projects. If you or your client’s team are struggling with system selection, project planning / execution, validation planning / execution, or IT complaince (SOX, GxP), we can quickly come in, assess the situation and make expert recommendations to get the project and your client on the path to success.

For SaaS companies looking to expand their product offering into the life sciences sector, we can assess your current solution offering, make recommendations to align with industry expectations and requirements, and assist with non-code, solution development.

Solutions2Projects services include

  • IT strategy and IT compliance roadmaps

  • IT system selection

  • IT vendor/supplier audits

  • IT compliance (SOX, FDA, EU, 21 CFR Part 11)

  • Computer validation / software assurance

Consultants’ Consultant Services Include

  • System selection advisory

  • Project planning advisory

  • Validation planning advisory

  • Failing project recovery

  • IT SOX controls advisory

  • GxP system assessment and advisory

  • Business and system requirements for all life sciences companies areas including clinical, regulatory, finance, manufacturing, quality, distribution, procurement, contracts, and HR.

  • Ista Pharmaceuticals

  • Kinnate

  • Pacific Biosciences

  • Paradigm Management

  • Pharmacyclics

  • Proteus Biomedical

  • Santen Pharmaceutical

  • Stanford Medicine

  • Tethys

  • Theravance

  • Tobira

  • Topcon Medical

  • XenoPort

  • XWPharma

past clients

  • AcelRx

  • Achaogen

  • Alexza Pharmaceuticals

  • Cholestech

  • Chrono Therapeutics

  • Comentis

  • Exelixis

  • Five Prime Therapeutics

  • Fluidigm

  • Gener8

  • HealthTell

  • HemoSense

  • Hyperion Therapeutics