Regulatory Affairs
FDA Submissions
Review, Preparation and Submission of ANDA’s, NDA’s, IND’s, ADE reports and DMF’s
Review of Drug product labeling, SOPs and Batch RecordsTechnical writing(Reports, Protocols, Specifications, Policies and procedures)
Audits
Documentation and Facility Audits, Recommendations and help implement corrective actions
Trainings
Presentations of regulatory submission requirements as per FDA and ICH guidelines and recommendations
Technical assistance
Regulatory filings, Suitability Petitions, Contacting regulatory agencies on behalf of clients
.