OnResp partners with Pharma, Biotech, Medical device companies and research institutes to expedite dry powder and soft mist inhalation solutions, targeting pulmonary and nasal delivery of biologics and small molecules.
Our services
CMC technical project leadership 
Oversight of prototype technical development according to project timeline and budget objectives.
CMC strategy, risk assessment and contingency planning pertaining formulation, process development, GMP production and release.
Project supply chain management, acting as primary contact on behalf of the hiring party.
– Identification, screening, evaluation, selection, audit and management of external vendors (raw material, equipment, CRO/CDMO/CMO project teams, Consultants) towards compliance with product quality, project timeline and budget objectives.
– Preparation of Requests for proposal (RFPs).
– Review and approval of non-GMP and GMP documentation (methods, protocols, master batch lab/production records, reports and others).
Preparation of regulatory documentation for new drug product applications.
Oversight of prototype technical development according to project timeline and budget objectives.
CMC strategy, risk assessment and contingency planning pertaining formulation, process development, GMP production and release.
Project supply chain management, acting as primary contact on behalf of the hiring party.
– Identification, screening, evaluation, selection, audit and management of external vendors (raw material, equipment, CRO/CDMO/CMO project teams, Consultants) towards compliance with product quality, project timeline and budget objectives.
– Preparation of Requests for proposal (RFPs).
– Review and approval of non-GMP and GMP documentation (methods, protocols, master batch lab/production records, reports and others).
Advisory
State of the art, patent landscape and market research analysis adapted to client need.
Design of feasibility studies for development, tech-transfer and scale-up of formulation, process, and
final drug product development in research or GMP environment, from concept to lab and production.
State of the art, patent landscape and market research analysis adapted to client need.
On-demand training
Production of training content and/or online or in-person courses on respiratory drug product development, tailored to non-technical and technical teams, according to client need.
Stay tuned.
