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Hamza Bawab
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Dave Morton
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Charles Buckwalter
The services provided by Arbour group llc are satisfactory. The website provides all the necessary information, and their solutions have helped us achieve our goals. I would recommend them for their reliable and efficient services.
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With 20 years of compliance, Arbour Group is a leading provider of regulatory compliance products and services for the life sciences industry.
Arbour Group LLC: Your Trusted Partner for Regulatory Compliance in the Life Sciences Industry
Arbour Group LLC is a leading provider of regulatory compliance products and services for the life sciences industry. With over 20 years of experience, Arbour Group has established itself as a trusted partner to pharmaceutical, biotech, medical device, and other life sciences companies worldwide.
At Arbour Group, we understand that regulatory compliance is critical to the success of your business. Failure to comply with regulations can result in costly fines, product recalls, damage to your reputation, and even legal action. That's why we offer a comprehensive range of compliance solutions designed to help you navigate complex regulations and achieve compliance quickly and efficiently.
Our team of experts includes former FDA officials, industry veterans with decades of experience in regulatory affairs and quality assurance, as well as IT professionals who specialize in software validation and data integrity. We work closely with our clients to understand their unique needs and challenges so that we can provide tailored solutions that meet their specific requirements.
Our services include:
Regulatory Consulting: Our team provides expert guidance on all aspects of regulatory compliance including FDA submissions (INDs/NDAs), clinical trial design/execution/reporting (Phase I-IV), labeling/packaging requirements (US/EU), GMP/GLP/GCP audits & inspections (FDA/EU/WHO), pharmacovigilance/safety reporting (US/EU).
Quality Assurance: We offer comprehensive quality assurance services including SOP development/review/approval; CAPA management; supplier/vendor qualification & management; internal audit programs; training programs for employees/vendors/suppliers.
Validation Services: Our IT professionals specialize in software validation & data integrity assessments for computerized systems used in regulated environments such as LIMS/LMS/eQMS/eCTD publishing tools etc., ensuring they are compliant with 21 CFR Part 11 requirements.
Managed Services: We provide managed services such as hosting/validation/maintenance/support for our proprietary software products like eValidatorβ’ - an automated validation tool which reduces time/costs associated with manual testing/validation activities by up to 80%.
Training Programs: We offer customized training programs on various topics related to regulatory affairs/compliance/quality assurance/data integrity etc., delivered by experienced trainers who have worked extensively within the life sciences industry.
Arbour Group's commitment to excellence is reflected in our ISO 9001 certification which ensures that our processes are standardized across all locations globally. Additionally, we have been recognized by Inc Magazine as one of America's fastest-growing private companies multiple times since inception due largely because we deliver high-quality results consistently while maintaining competitive pricing structures compared against other providers within this space!
In conclusion,
If you're looking for a reliable partner who can help you achieve regulatory compliance quickly and efficiently while minimizing risk exposure then look no further than Arbour Group LLC! With over two decades worth expertise under its belt coupled together alongside an impressive track record delivering high-quality results consistently at competitive prices compared against other providers within this space - there really isn't anyone better suited than us when it comes down towards providing top-notch service levels throughout every stage involved from start-to-finish!
- Website
- arbourgroup.com
- info@arbourgroup.com
- Address
- 1 parkview plaza
- Categories
- Information technology and services