Magellan Pharmaceutical Development has extensive experience
in drug and biologics submissions. In today’s
intensely competitive and highly regulated
environment, Magellan Pharmaceutical Development provides a
partnering relationship to help you with product
submissions as well as post-approval support. From
IND stage to annual reports, our staff can assist
you with regulatory document review and
preparation.
Please give us a call with any questions or submit a project
to us online.
Services
- Preparation of CMC Sections
- New Drug Applications (NDA)
- Supplemental New Drug Applications (sNDA)
- Abbreviated New Drug Applications (ANDA)
- Investigational New Drug Applications (IND)
- Biologic License Applications (BLA)
- Preparation of Annual Reports
- Development of Conformance Guides
- Assembles all Approval Information into one Document
- Evaluates Adherence to Commitments
- Assists in Preparation of Annual Reports and Supplements
- Identifies Discrepancies or Potential Inspection Issues
- Review of Draft CMC Documents
- Preparation of Drug Master Files (DMFs)
- Preparation of Monographs
- FDA Interaction
- Statistical Trend Analysis of Stability Data (SAS
& FDA Statistics Software)
- Preparation of Development History Documents
- Preparation of Labeling and Drug Product Listing
Submissions
- Safety Reporting
- Preparation of Regulatory SOPs
- Regulatory Consultation
