Scientia Bioengineering Consulting, LLC provides technical R&D, quality, clinical, and regulatory consulting for medical device and pharmaceutical companies. We work with a broad range of organizations, including venture capitalists, start-ups, and large corporations, and provide support throughout the product life cycle, from concept through commercialization.
Our scientific and technical expertise includes wearable and implanted medical devices, physiological sensors, drug delivery systems, and drug-device combination products. Professional work includes both strategic and hands-on research and development, project management, regulatory, quality, and clinical affairs.
Services:
- Product design and development
- Program/project management
- Design controls and risk management
- Technology assessment
- Regulatory strategy
- Nonclinical and biocompatibility evaluation
- Clinical affairs management
- Intellectual property
- Quality compliance and remediation
Past projects:
- Top 20 Global pharmaceutical company: Individual contributor for remediation and standardization of design control and risk management documentation for parenteral biologic-device combination products. Device representative for delivery of biologics into tissue via electroporation.
- Top 10 Global pharmaceutical company: Leader and individual contributor for laboratory quality compliance and data integrity activities in medical device testing laboratory.
- Top 10 Global medical device company: Nonclinical, CMC, and regulatory advising for development drug-device combination product to provide local anesthesia for ear tube insertion as an alternative to general anesthesia.
- Small medical device company: Project management, nonclinical, biocompatibility testing, and technical development consulting for implanted sensors and electro-optical reader devices.
- Small medical device start-up: R&D and clinical lead for wearable medical devices for digital health applications.
- Big five tech company, life sciences division: Technical and clinical consulting on biological and chemical aspects of glucose sensing contact lens. Technical advisor on nanoparticle delivery.
- Multiple corporate strategic partnering and venture capital firms: Technical assessment for due diligence, including ophthalmic medical device, biologic-device combination product, inhalation device, and transdermal drug-device combination product.
- Multiple companies: Technical advisor for microneedle, iontophoretic, otic, ophthalmic, implanted, and microfluidic drug delivery systems. Design control advisor, individual contributor, and independent reviewer for medical devices.
Scientia Bioengineering Consulting, LLC 