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INFOwww.southsix.cominfo@southsix.com(774) 425-4434

LOCATIONSMassachusettsTexasWashington

CONNECT WITH US ONLinkedIn: south-6Facebook: @south6inc

Regulatory and ComplianceSouth 6 offers a complete suite of regulatory and compliance consulting services, from individual consultants to project teams to strategic outsourcing. Our individual consultants and project teams deliver the business knowledge and hardto-find technical expertise our clients need on their projects. Our consultants can fill knowledge gaps on current teams, or work independently under our clients’ direction as quality assurance managers, regulatory affairs associates and validation engineers. Our strategic outsourcing services incorporate established industry know-how, expertise in emerging technologies and accelerated results to bring life-saving products and innovation to market faster and deliver the best outcomes for our clients.

South 6 recruits experienced consultants to assist clients in the pharmaceutical, biotechnology, medical device, and related life science industries with quality, validation, compliance, auditing, and statistical projects, and to achieve compliance with FDA, CE Marking, and ICH guidelines and regulations. Our consultants’ expertise includes

Regulatory Affairs: Writing submissions, documentation, and remediation including 510(k) submissions, AER’s, PMA’s, IDE, remediation/resolution management, technical papers and complaint handling Quality Assurance &

Quality Engineering: Development of complete quality systems, including complaint management, deviation management, CAPA, change control, training, and document management and control. Methodology, policy, and procedure development. Gap/Risk assessment. Recalls, MDR’s and complaint handling. Auditing to determine compliance with applicable regulations, guidelines, procedures, and policies for Part11, quality systems, vendors, and IT compliance.

Validation: Developing Standard Operating Procedures (SOP), validation protocols (IQ, OQ,PQ), and validation master plans. Conducting validation executions and writing validation reports. Computer systems, software, process, cleaning, methods, facilities and utilities, equipment, IT infrastructure, and 21 CFR Part 11.

Statistical Analysis: Statistical design and analysis for all phases of clinical trials, from the beginning planning stages through study completion and report preparation.