PharmaCRO
Consultancy providing product development services for medical devices, drug delivery systems and drug-device combination products. Services cover integrated planning and execution across design, manufacturing, regulatory strategy, clinical studies, toxicology and commercialization, with international experience.
Industries
Nr. of Employees
small (1-50)
PharmaCRO
Sunnyvale, California, United States, North America
Products
Lateral flow immunoassay device development project
Advanced a lateral flow immunoassay from feasibility to clinical studies and regulatory 510(k) submission, including clinical supplies and CRO coordination.
Inhalation-route systemic delivery platform project
Development of thermal aerosol and inhalation platforms, team assembly, cGMP/QSR process implementation and multiple IND filings.
Inhaler combination product development for asthma and COPD
Regulatory and CMC strategy development and formulation/device optimization for inhaled drug delivery.
Oral controlled-release formulation projects
Development of liquid and time-release oral formulations including chronotherapeutic release profiles and pediatric formulations.
Non-invasive continuous glucose monitoring system development
Sensor design and manufacturing development using reverse iontophoresis for continuous glucose monitoring.
Transdermal contraceptive patch development
Formulation, materials integration and process development for a 7-day transdermal system and tech transfer to partner.
Lateral flow immunoassay device development project
Advanced a lateral flow immunoassay from feasibility to clinical studies and regulatory 510(k) submission, including clinical supplies and CRO coordination.
Inhalation-route systemic delivery platform project
Development of thermal aerosol and inhalation platforms, team assembly, cGMP/QSR process implementation and multiple IND filings.
Inhaler combination product development for asthma and COPD
Regulatory and CMC strategy development and formulation/device optimization for inhaled drug delivery.
Oral controlled-release formulation projects
Development of liquid and time-release oral formulations including chronotherapeutic release profiles and pediatric formulations.
Non-invasive continuous glucose monitoring system development
Sensor design and manufacturing development using reverse iontophoresis for continuous glucose monitoring.
Transdermal contraceptive patch development
Formulation, materials integration and process development for a 7-day transdermal system and tech transfer to partner.
Services
End-to-end consulting for device product design, human factors, verification/validation, manufacturability and regulatory compliance.
Support for formulation, preclinical development, clinical evaluation, manufacturing scale-up and regulatory (IND/NDA/ANDA) documentation for drug and drug-device products.
Detailed technical evaluation of concepts and technology platforms to identify feasibility and key technical and regulatory risks.
Project management services to coordinate cross-functional teams and ensure timely, budget-conscious product development execution.
End-to-end consulting for device product design, human factors, verification/validation, manufacturability and regulatory compliance.
Support for formulation, preclinical development, clinical evaluation, manufacturing scale-up and regulatory (IND/NDA/ANDA) documentation for drug and drug-device products.
Detailed technical evaluation of concepts and technology platforms to identify feasibility and key technical and regulatory risks.
Project management services to coordinate cross-functional teams and ensure timely, budget-conscious product development execution.
Expertise Areas
- Regulatory strategy for combination products
- Medical device design and human factors
- Drug formulation and CMC
- Inhalation drug delivery
Key Technologies
- Lateral flow immunoassay
- Reverse iontophoresis for glucose monitoring
- Transdermal drug delivery systems
- Nebulizer and aerosol drug delivery
News & Updates
Discussion of regulatory risks when requesting product designation from the FDA Office of Combination Products, illustrated by a legal challenge to OCP's designation of a product's primary mode of action.
Founder is co-inventor on 63 US and foreign patents and co-author on 23 peer-reviewed journal articles and poster presentations.
Discussion of regulatory risks when requesting product designation from the FDA Office of Combination Products, illustrated by a legal challenge to OCP's designation of a product's primary mode of action.
Founder is co-inventor on 63 US and foreign patents and co-author on 23 peer-reviewed journal articles and poster presentations.