515 Consulting Group provides a wide range of solutions and services to Pharmaceutical, Biotech and Medical Device companies throughout the world. Our advice and integration services include preparing for, selecting, implementing, validating and operating e-Regulatory applications based on CTD, eCTD and upcoming RPS standards.
515 Consulting can also help you with planning, preparing or outsourcing your submissions whether they are in electronic or paper (eCTD, CTD, IMPD, 510(k) etc.) format.
Our services include:
- Submission Publishing (Staff Augmentation/Assistance or Outsourcing)
- Training (eCTD, CTD (paper) to eCTD Transition, new FDA M1, and customized training)
- Submission Planning
- Publishing tool selection
- Paper to electronic transition
- Conversion from paper DMF to eCTD format (mandatory by May 5, 2017)
- FDA, CA and EMA Electronic Submissions Gateway (ESG) Setup and Testing
- Authoring Templates Customization and Training
- Publishing Tool Installation and Software Validation
- Business Continuity Implementation (backup, off-site implementation etc.)
Additional services are also available.