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Preparation, Submission and Maintenance of Marketing Applications |
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Preparation of Regulatory Strategy Assessments
- Submission planning and management
- Fast track and orphan applications
- Product Registration [ NDA, ANDA, BLA, NDS, MAs, MAA (Centralized/decentralized/MRP)]
- Paper and/or eCTD formats
- Coordination, preparation, submission and follow-up responses to Agency requests for information and action letters
- Translation management
- Life cycle management and submissions (Abridged MAAs and sNDAs, renewals and variations)
- Marketing Application maintenance (Amendments, Periodic Safety and Annual Reports, post-submission updates)
- Review Statistical Analysis Plans, CMC, nonclinical and clinical study reports
- Prepare CMC, nonclinical, clinical subsections and labeling
- Drug Master Files (DMF)
- QP services
- Pharmaceutical and medical
- Pharmacovigilance
- Identify/manage contract manufacturers or contract labs (CMC and Tox)
- PAI preparation
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