Services offered by Bridging Science to Health, LLC

Comprehensive Regulatory and Development Services

Strategic Regulatory Product Development Plans Providing Guidance from initial compound discovery through FDA approval
Custom Target Product Profiles
Health authority strategy, meetings, and negotiations (EMEA, FDA, TPD, Mexico, China, Russia, Australia, etc.)
Dossier (IND, CTX, NDA, MAA, eCTD, BLA, IDE, PMA, etc.) strategy, oversight and preparation and Project Management including publication
Strategic dossier prosecution
Dispute resolutions, compliance issue responses
Strategic writing of background packages, white papers, etc.
Orphan drug and fast track applications
Authorized International US Representation

Pre-Clinical strategic development programs custom designed to most efficiently support clinical progress
CTL & CMO selection and Project Management
Targeted cGMP & GLP implementation and compliance documentation
Data and pre-clinical report supervision

CTL and CMO selection including audit and "Gap Analysis" for product and client suitability (U.S. and International sites including Asia)
Project Management of product manufacturing, analytical testing, process development, formulation, registration and market launch from research
Quality Agreements and DMF review
Stability Program Development and oversight
CMC Dossier development and review

Quality systems development and integration to support FDA/ICH compliance
Facilities analysis and quality GLP, and GMP audits including analytical and bioanalytical methodology
SOPs and all quality documentation for GMP, GLP, and GCP
Quality assessment and audits for all contract organizations
FDA audit training and preparation
Quality by Design