Assembling a great team is critical to increasing the likelihood that an ophthalmic product development program will be successful. Oftentimes, companies leverage expert consultants to staff these teams, gaining access to decades of experience while maintaining a flexible workforce. The Oculos team and our sister company – Lumino Advisors – provide a wide array of consulting services to support our clients’ myriad of needs. The consultation offered by Lumino is rooted in decades of experience in ophthalmic product development, and is a result of many successful product development efforts and commercial launches.
A sampling of the Advisory Services offered by Oculos and Lumino Advisors:
- Preclinical strategy development, study design, etc.
- Regulatory strategy development, authoring of regulatory submissions, etc.
- Technical consulting support focusing on analytical chemistry and microbiology
- Extractable/leachable consulting, test protocol development, etc.
- Sterilization validation consulting (ethylene oxide, steam, gamma, E-beam)
- Formulation consulting
- Biological safety evaluation reports
- Quality system development/deployment
- CMC consulting services
- Ophthalmic clinical research consulting