515 Consulting Group provides expert advice and systems integration services to Pharmaceutical, Biotech and Medical Device companies as well as other service companies involved in these areas such as CROs. We focus on Regulatory activities such as Submission, Drug Safety Management and Management and Tracking of Regulatory Activities. Our advice and integration services include preparing for, selecting, implementing, validating and operating e-Regulatory applications including eCTD and RPS solutions.
515 Consulting can also help you with planning, eCTD transition, preparing or outsourcing your submissions, electronic or paper (eCTD, CTD, 510K etc).
515 Consulting Group provides solutions and services for:
- eCTD, CTD, NEeS, and paper regulatory submissions
- RPS
- eCTD/CTD/IMPD/IND Authoring Templates
- Pharmacovigilance drug safety management
- Regulatory activities management and tracking
Our Services include:
- Training (eCTD, CTD, eCTD Transition etc.)
- Submission Planning
- Submission Preparation (Assistance or Outsourcing)
- Authoring Templates Customization and Training
- Software Validation
- Software Installation
Customized services are also available.
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