Team Regulatory

Core Regulatory Consulting

Filing of NDA / ANDAs in US and ASMFs in EU
Preparation of Generic Applications such as Paragraph II, III and IV
Post approval maintenance and submissions of PAS, CBE 30/CBE, Annual Reports in US and EU
Help with creation of customized FDA regulatory/development strategies
Help with writing all submission documents
Design Final Printed Labeling and Container Lab
Help with responding to FDA questions during the approval process
Help with eCTD process and provide eCTD Preparation Services
Help with filling annual reports, adverse reactions, and ongoing CMC updates
Manage Good Manufacturing Practice (GMP) and clinical site audits.
Act as a U.S. Agent for non U.S. companies
Provide Pharmacovigilance Services including PADER and ICSR Submissions