Regulatory and Compliance
We provide contract regulatory services to our clients in the biopharmaceutical, biologics, and medical device industries to develop products for the US market or to obtain US FDA approval and/or clearance. Our range of highly customizable services includes regulatory submission and compliance, and quality system/CGMP design and implementation.
Our services at a glance:
Our quality system and GMP services for diagnostic, biopharmaceutical and biologics companies include:
· SOP design and implementation
· Quality System/CGMP design and implementation: 21 CFR Parts 210/211, 600, 601, 610, 820, and 1271
· Quality system training and audits
· Supplier qualification
· Manufacturing facilities design and qualification
· Manufacturing process and equipment qualifications: DQ, IQ, OQ, and PQ
· Deviation and complaint handling system design and implementation
· Corrective and preventative action (CAPA) system design and implementation
· Software and system validation: 21 CFR Part 11
· Pre-approval, Pre-license, GMP/QSR inspection training and mock inspections
· Warning Letter action plans and responses
Our regulatory services for diagnostic, biopharmaceutical and biologics companies include:
· Predicate device identification
· Device classification (513(g))
· Protocol and study design preparation
· Preparation for and conduct of meetings with regulatory bodies
· Pre-IDE, Pre-IND, Type A, B, and C meeting preparation (scheduling, information package development, presentation assistance, and FDA mediation)
· Preparation of pre-market submissions: IDE, PMA, 510(k), IND, NDA, ANDA, BLA applications, supplements and annual reports
· Device Master Files and Drug Master File preparation
Who to contact:
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