Pharma & Biotech Regulatory
Pharmaceutical regulatory strategy from development planning through approval.
Pharmaceuticals
Small molecule INDs, NDAs, ANDAs, eCTD lifecycle.
How we serve Pharmaceuticals.
More than just writing a regulatory submission for a Pharmaceutical Program – you need to plan the sequence of your regulatory requirements; provide Clinical Discipline; have CMC alignment with your Label Strategy; provide Quality Execution throughout Development to Approval and Lifecycle Management.
We can assist Small Molecules; Sterile Injectables; Inhalation Products; Transdermal Systems; Combination Drug Led Products; Post Approval Changes; Global Submission Strategies.
Pharmaceutical Development Teams need assistance in transforming disparate development data into one cohesive Regulatory Story: Pre-IND Planning; Authoring of IND/NDA/BLA documents; Building out an eCTD Structure; Correspondence with FDA regarding regulatory issues; The Interface between CMC and Device Requirements as applicable; Human Factors as applicable; Preparation of Quality System for implementation; Control of Change during the Lifecycle of your product.
21 CFR Part 312 & 314
21 CFR Part 210 / 211
ICH CTD / eCTD
ICH Q8 / Q9 / Q10 / Q12
FDA Pre-IND and End-of-Phase interactions
NDA / BLA lifecycle management
Combination product requirements (where applicable)
Where we typically engage with Pharmaceuticals clients.
Service detail
IND / NDA / BLA Submissions
eCTD authoring, FDA correspondence and submission lifecycle management.
Combination Products
Drug-device and biologic-device strategy for device constituent products.
Quality Management Systems
GxP quality systems, CAPA, supplier controls and inspection readiness.