Enhanced Compliance Inc.
Orla McCullagh-Blount currently serves as Senior Director of Business Development at Enhanced Compliance (ECI), a role focused on driving business development and delivering exceptional consulting services in project management, research and development, manufacturing engineering, quality, risk management, regulatory matters, post-market surveillance, mergers and acquisitions support, and technical services within the life sciences sector. Prior to this, Orla held a series of progressively responsible positions, including Director of Quality Systems and PMO at ECI, Senior Quality Manager at St. Jude Medical, and various roles at Boston Scientific, where responsibilities spanned quality systems compliance and research and development engineering. Orla's strong educational background includes an MBA and a Master’s in Management from Babson F.W. Olin Graduate School of Business, as well as a Bachelor’s degree in Biomedical Engineering from Ulster University.
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Enhanced Compliance Inc.
Enhanced Compliance Inc. (ECI-Rx) offers Regulatory, Quality, Engineering Consulting services and Shared Business Process Solutions for the Life Sciences Industry. We specialize in the medical device, pharmaceutical, biotech and nutritionals market sectors. Headquartered in Michigan, Enhanced Compliance Inc. works with clients around the world. We provide a range of flexible and comprehensive services to ensure our clients meet FDA and global compliance regulation requirements, along with ensuring quality, efficacy and safety in bringing to market innovative life-changing – even life-saving – advancements in the life sciences field. Services include Non-Compliance (Consent Decree and Warning Letter) Remediation, Regulatory Compliance, M&A due diligence, Post Acquisition integration, Program Management, Manufacturing, Research & Development, Validation and Technical Services. Our dedicated team of industry professionals and program managers have extensive experience and bring a wealth of proven strategies, best practices, knowledge, tools and methods. We assemble project teams to best meet the needs of the client and can supply resources to multiple client sites and quickly scale as projects evolve, ensuring project success. Our focus is on assisting clients in establishing compliance protocols for products in development, improving existing operations and facilities to stay compliant in a rapidly changing environment, and aiding with the successful resolution and remediation of quality and compliance issues.