515 Consulting Group provides expert advice and systems integration services to Pharmaceutical, Biotech and Medical Device companies throughout North America. 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, preparing or outsourcing your submissions, electronic or paper (eCTD, CTD, 510K etc).
515 Consulting Group provides solutions and services for:
- eCTD
- RPS
- eCTD Authoring (Word) Templates
- Pharmacovigilance
- Document format validation
Our Services include:
- Software Installation
- Training (Product-based, technology based (e.g. eCTD etc))
- Submission Planning
- Submission Preparation (Assistance or Outsourcing)
- Software Validation
- IT Systems Validation
Customized services are also available.
Contact us by phone: +1 (206) 529-5153 or email:
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