Expertise
Regulatory & Submissions
Our consultants have reviewed and inspected against submissions from inside the Agency. We build the part of a submission that has to survive contact with reality: how the product is made, controlled, validated and documented — and we make sure the site can demonstrate it.
Where we help
Submission work at xFDA is technical. We write and review manufacturing, CMC and quality system content, reconcile it against what the site actually does, and prepare the people who will have to explain it.
- 510(k), De Novo, PMA and IDE technical and quality content for devices
- IND, NDA, ANDA and BLA CMC and manufacturing sections for drugs and biologics
- Design history file, device master record and technical documentation reconciliation
- Process, cleaning, sterilization and method validation packages supporting a filing
- Pre-approval and pre-license inspection readiness, run by former FDA investigators
- Deficiency letters, Additional Information requests and information request responses
- Post-approval change strategy: supplements, amendments and annual reports
Where we stop
Global regulatory strategy, international registrations and full outsourced regulatory affairs are not our specialty, and we say so. For that work we point clients to GlobalRegulatory.com and often work alongside them on the same program.
Start a project
Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.