Your Trusted Source of Regulatory Support
Let our team support your regulatory needs at both the strategic and operational levels:
- Provide expert advice on regulatory strategy across all phases of development.
- Deliver critical review and/or preparation, technical writing, and assembly of:
- Investigational product applications
- Marketing submissions suitable for FDA as well as Global Health Authorities
- Handle day-to-day regulatory operations to assure compliance.
- Liaise with FDA to expedite drug development and marketing approvals and resolve issues.
- Prepare Fast Track and Breakthrough Therapy Designations.
- Support Orphan Drug Designation Applications
- Compile and review labeling including PLR format; collaboration with outside vendor for labeling conversion to SPL format.
- Prepare/submit electronic Labeler Code Requests, Establishment Registrations/Renewals and Drug Product Listings (eDRLS).
We provide the following CMC-related activities:
- Prepare, assemble and review CMC sections for investigational and marketing applications filed to regulatory authorities across all type of drug/biologic products and applications (INDs, NDAs [505(b)(1), 505(b)(2)], BLAs, ANDAs, DMFs).
- Conduct CMC gap assessment.
- Prepare responses to CMC-related queries from health authorities.
- Assess change controls and provide submission strategy.
- Lead Agency meeting preparation.
- Prepare CMC section for annual reports.
- Post-approval maintenance and lifecycle management.
- Management of control correspondences.
Submission Services via FDA’s ESG:
- Investigational New Drug Applications (IND) and Amendments
- New Drug Applications (NDA), Biologics License Applications (BLA) and Abbreviated New Drug Applications (ANDA)
- IND, NDA, BLA, DMF and ODD Annual Reports
- Drug Master Files and Amendments/Updates
- Labeler Code Registrations
- Establishment Registrations and Drug Listings
- Structured Product Labeling (SPL) Coordination and Submission
Submission Services via FDA’s CDER NextGen Portal:
- Control Correspondence
- Orphan Drug Designation Applications