It doesn’t matter what type of Quality service you require; NECLLC can deliver. We
have over 50 years of cGMP/cGCP expertise employing risk based and phase appropriate approach to cGMP and cGCP Quality System and Operations execution and remediation.
cGCP experience ranges from CRO and study oversight, investigator site, vendor, and internal/system audits that span a wide range of therapeutic areas, services, and geographic locations.
cGMP experience ranges from audit program creation and execution, product release, batch
record review, Quality System execution to full assessment and remediation of
Quality System Elements to creating training programs and driving and
implementation of a Quality Compliance function, supporting audits and
inspection readiness and assessing FDA trends. We do this while leveraging the
resources and infrastructure already in place.
We strive to cultivate transparent and collaborative partnerships with internal and external stakeholders to become a trusted resource on the analysis and interpretation of cGCP and cGMP requirements and health authority regulations.
Quality Management System
Book your free consultation to discuss the needs of your company and learn more about how we are here to help!
I have worked with NE Consulting LLC for the last year and nine months. They have brought a level of knowledge, professionalism, and humor in leading our Quality organization that was significantly impactful. I
have also received great feedback on their leadership and management skills. I would not hesitate to recommend NE Consulting LLC to any organization.
NE Consulting LLC was a pleasure to work with. They are a hard workers and are very good at what they do. They have extensive knowledge in Quality and Compliance and can identify and remediate compliance gaps within an organization. Mike also has a great personality, allowing him to communicate effectively
with all departments within an organization. It would be a pleasure to be able to work with NE Consulting LLC again in the future.
I have worked with NE Consulting LLC on multiple projects and have found them to be highly knowledgeable in Quality Systems. They are a pleasure to work with and face challenges head on.