Moonbay Technology works with a number of professional and highly skilled companies who offer services to assist life science companies. The following represent a few:
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Rescentris provides CERF enterprise scientific content management software to help organizations protect their R&D investments and intellectual knowledge assets in a paperless, collaborative, and more efficient environment. CERF caters to biotechnology labs by electronically capturing all the research documents and data necessary to document studies and assemble FDA submissions. Rescentris provides 21 CFR 11 Compliant ELN solutions tailored to benefit your entire organization by combining electronic lab notebook (ELN) technology with scientific document management to make lab information available 24/7. eCERF™, our full-featured Software-as-a-Service ELN, minimizes costs, risks, and IT overhead, and with integration of Iron Mountain Digital Archiving our Enterprise ELN is an end-to-end solution for creating, managing and preserving lab records.
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Distributed Compliance Solutions is the premier compliance solutions company of staff, technology and business process for government, life science and health organizations. With scalable, economical, and reliable turnkey product solutions and state-of-the-art hosting facilities, DCS is making it easier for business to focus on their goals, collaborate with their partners and bring products and services to market earlier. |
e-SubmissionsSolutions.com (a California corporation) was founded by Antoinette Azevedo in 2000 to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Ms. Azevedo's clients range from large, international pharmaceutical companies to small, virtual biotechnology companies -- all attempting to be better prepared to manage controlled documents and produce electronic INDs and drug/biologic registrations. |
With over 30 years of experience, Jeff Miller (JP Miller Associates) is recognized for exceptional regulatory leadership, strategic planning, regulatory management, and health authority liaison capabilities. Focused expertise is provided for Formal Meetings with Health Authorities (requests, briefing documents, rehearsals, facilitation), strategic written correspondence, writing and reviewing original clinical trial and commercial applications (IND, CTA, NDA/MAA, ODD, other) and Product Development Plans. Expertise includes US with EU international experience for development of drugs, biologics and drug-device combinations. Compliance expertise with FDA/State of California FDA/MAA site inspection preparations, GXP audits, hosting inspections, performing gap analyses, writing & editing SOPs, perform due diligence, and crisis/issues management. |

MWA offers a full range of consulting services in GCP, GLP, and GMP compliance. MWA provides consulting expertise from development through commercialization for the pharmaceutical, biotechnology, and medical device industries. MWA is a certified woman-owned business. |
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