From strategy to final clearance or approval, TAMM Net has the knowledge and relationships to expedite the regulatory process.
TAMM Net strategically negotiates the appropriate regulatory application with the FDA to obtain a successful outcome. We consult with the FDA, perform facility audits for both Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), software validation for devices or clinical trials, and system and process validations. Whether you need to outsource your VP Regulatory Affairs function, or just need an audit performed, TAMM Net has the expertise.
REGULATORY TASKS WE ROUTINELY PERFORM FOR OUR CLIENTS:
- Develop a regulatory strategy.
- Coordinate with research activities.
- File regulatory Submissions.
- Expertise in software validation and verification.
- Diagnostics and companion diagnostics.
- CE Mark application & Coordination with Notified bodies
- Perform compliance auditing: GMP, GLP, software validation.
- Submit: IND, IDE, 505(b)(2), 510(k), PMA, ANDA, 513, BLA, and NDA.
- Consult internationally with: EMEA, FDA (Korea), Kiro-shu or PMDA (Japan), TGA (Australia), HPB (Canada), SFDA (China), ANVISA (Brazil), and MOH (Israel).