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Your Partners in Compliance

General Info
Over thirty years experience in the pharmaceutical / medical device industry. Track record of instituting and maintaining high levels of Quality Assurance, and leadership in the pharmaceutical, medical devices and biological industries. Experts in compliance, auditing, investigations, product complaint, validation, SOP development and assessment, PDMA, cGMP, CFR, document control (First Docs, Documentum, etc.), State and Government regulations, inspections, SOP Development, Quality Control, FDA Regulations, Regulatory Affairs, change control. Expertise in all industry related ISO regulations. Experience in European regulatory body regulations, Utilities/Facility and equipment validation.
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Services/Products
FDA Compliance Computer System Validation Internal Audits Vendor Audits Supplier Audits CFR Chapter 21 Part 11 Audits CFR Chapter 21 Part 203 & 205 PDMA Audits CFR Chapter 21 Part 820 Audits
Associations
Associated with all the major pharmaceutical companies in the industry
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Details

Phone: (888) 429-4624

Address: PO Box 370, Chesnee, SC 29323

Website: For all your compliance needs

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