Regulatory Pathways
Consultancy providing regulatory, clinical, quality, statistical, medical writing, scientific and technical support to medical device, biologic and pharmaceutical developers. Services include regulatory strategy and submissions (US FDA and EU MDR), clinical trial design and execution, quality system implementation, post-market surveillance, and specialist technical support across areas such as sterilization, microbiology, software verification, and photonics-based devices.
Industries
Nr. of Employees
small (1-50)
Regulatory Pathways
California, USA (company registered as a California corporation)
Products
Regulatory Consulting for Medical Devices, Biologics, and Pharmaceuticals
Consulting services to guide companies through regulatory approval processes for medical devices, biologics, and pharmaceuticals, including FDA and EU MDR compliance.
Clinical Consulting and Clinical Trial Management
Support in designing, conducting, and managing clinical trials and studies to generate data for regulatory submissions and product approvals.
Statistical Consulting and Biostatistics Services
Statistical design, analysis, and reporting services for clinical trials and regulatory submissions in medical product development.
Medical Writing Services
Preparation and management of regulatory and clinical documents required for medical product submissions and compliance.
Quality Systems and Regulatory Compliance Consulting
Consulting on quality system implementation, risk management, and regulatory compliance for medical product development and manufacturing.
Software and Cybersecurity Consulting for Medical Devices
Consulting on software development lifecycle, risk analysis, verification, validation, and cybersecurity compliance for medical device software.
Regulatory Consulting for Medical Devices, Biologics, and Pharmaceuticals
Consulting services to guide companies through regulatory approval processes for medical devices, biologics, and pharmaceuticals, including FDA and EU MDR compliance.
Clinical Consulting and Clinical Trial Management
Support in designing, conducting, and managing clinical trials and studies to generate data for regulatory submissions and product approvals.
Statistical Consulting and Biostatistics Services
Statistical design, analysis, and reporting services for clinical trials and regulatory submissions in medical product development.
Medical Writing Services
Preparation and management of regulatory and clinical documents required for medical product submissions and compliance.
Quality Systems and Regulatory Compliance Consulting
Consulting on quality system implementation, risk management, and regulatory compliance for medical product development and manufacturing.
Software and Cybersecurity Consulting for Medical Devices
Consulting on software development lifecycle, risk analysis, verification, validation, and cybersecurity compliance for medical device software.
Services
End-to-end development of regulatory strategies and preparation/management of submissions to regulatory authorities.
Protocol development, ICFs, CRFs, investigator training, IRB/EC submissions and clinical study management.
Statistical planning, SAP development, sample size calculations, database design/validation and analysis.
Design and implementation of QMS, SOPs, MDSAP preparation, supplier quality audits and inspection readiness.
Usability testing, IFU development, labeling artwork and UDI/GUDID registration support.
Oversight of sterilization, biocompatibility, electrical safety, EMC, preclinical testing and photonics/laser device testing.
End-to-end development of regulatory strategies and preparation/management of submissions to regulatory authorities.
Protocol development, ICFs, CRFs, investigator training, IRB/EC submissions and clinical study management.
Statistical planning, SAP development, sample size calculations, database design/validation and analysis.
Design and implementation of QMS, SOPs, MDSAP preparation, supplier quality audits and inspection readiness.
Usability testing, IFU development, labeling artwork and UDI/GUDID registration support.
Oversight of sterilization, biocompatibility, electrical safety, EMC, preclinical testing and photonics/laser device testing.
Expertise Areas
- Regulatory strategy and submissions (US FDA and EU MDR)
- Clinical trial design and management
- Statistical analysis and data management
- Quality systems and compliance (FDA QSR, ISO 13485, MDSAP)
Key Technologies
- Clinical study design and CRF development
- Statistical analysis and SAS programming
- Software verification and validation
- Cybersecurity threat assessment and modeling
News & Updates
Consultancy participation in approved IDE studies for a range of devices including ophthalmic implants, laser systems and glaucoma implants.
Assisted with 510(k) clearances for novel and digital diagnostic/monitoring devices, surgical instruments, lasers and ocular therapeutics.
Participation in successful Class II De Novo petitions for novel device types including home-use diagnostic devices and neurostimulation devices.
Support for premarket approval applications and orphan device (HUD/HDE) designations for first-of-a-kind ophthalmic and implantable devices.
Consultancy participation in approved IDE studies for a range of devices including ophthalmic implants, laser systems and glaucoma implants.
Assisted with 510(k) clearances for novel and digital diagnostic/monitoring devices, surgical instruments, lasers and ocular therapeutics.
Participation in successful Class II De Novo petitions for novel device types including home-use diagnostic devices and neurostimulation devices.
Support for premarket approval applications and orphan device (HUD/HDE) designations for first-of-a-kind ophthalmic and implantable devices.