515 Consulting Group provides a wide range of products 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 RPS standards.
515 Consulting can also help you with planning, preparing or outsourcing your submissions whether they are in electronic or paper (eCTD, CTD, 510K etc) format.
A small sampling of our services includes:
- Software Installation
- Training (Product-based, technology based (e.g. eCTD etc.))
- Submission Planning
- Submission Preparation (Assistance or Outsourcing)
- Software Validation
- IT Systems Validation
Additional and customized services are also available.
Contact us by phone: +1 (206) 529-5153 or email:
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