SERVICES
IntegRx has a network of consultants with FDA and extensive industry experience that are available to perform complex compliance audits and projects. Our services include:
- Management and coordination of extensive consulting projects to assure the quality work products and timely completion of requested services; Assisting clients in establishing project scope, deliverables, and timeframes for completion
- NDA/ANDA Mock Pre-Approval Inspections, cGMP Audits, and Due Diligence Assessments of international and domestic manufacturers and laboratories with identification of significant deficiencies and recommendations for remediation
- Audits of sterile and non-sterile drug products such as small and large volume parenterals, lyophilized parenterals, prompt and extended release tablets, enteric coated tablets, hard and soft gelatin capsules, liquids, ointments, suspensions, powders, and aerosols
- Assessments of sterile and non-sterile APIs and intermediates manufactured by chemical synthesis, fermentation, and oligonucleotide synthesis including activities and synthetic steps such as maintenance of working cell banks, fermentation, synthesis, cleavage, deprotection, extraction, ultrafiltration, chromatographic purification, crystallization, salt formation, isolation, lyophilization, milling, and micronization
- Audits of excipient and raw material manufacturers, contract manufacturers, contract chemistry and microbiology laboratories, and clinical supply manufacturers
- Evaluation of quality systems, procedures, process validation, change control, failure investigations, analytical testing procedures, equipment qualification and calibration, methods validation and transfer, stability programs and expiration dating, Out of Specification (OOS) and microbial investigations, training programs, computer system validation, electronic records and electronic signatures, facility design, containment, aseptic processing, environmental monitoring, HVAC systems, clean utilities, water systems, packaging, labeling, and product complaints
- Guidance in developing regulatory submissions, quality agreements, quality policies, quality systems, written procedures, containment strategies, aseptic processing strategies, bioburden control strategies, process and utility validations, equipment qualifications, analytical method validations and transfers, stability studies, data integrity programs, deviations, investigations, computer system validation, corrective and preventative action plans, and formal FDA correspondence
- Gap Assessments for critical compliance issues
- Development of strategies for FDA Inspection preparation and readiness
- Advise on critical compliance deficiencies, risk mitigation strategies, remediation plans, and FDA expectations.
- Assistance in composing written responses to FDA Inspections and Regulatory Actions, such as Warning Letters
- Preparation of clients for interaction with FDA District Offices and Centers
- Development of training seminars covering FDA expectations on a variety of regulatory issues