International Regulatory Business Consultants
Major Drugs - N/A, N/A, N/A
International Regulatory Business Consultants Employees
International Regulatory Business Consultants Details
RECOGNIZED HEALTH CARE MANUFACTURING INDUSTRY EXPERT as a pharmaceutical consultant with a blend of technical and business education, experience and expertise to provide scientific and regulatory consultant services to the global pharmaceutical, dietary supplement and medical devices and diagnostic products industries. Expertise in global manufacturing, quality assurance, regulatory affairs and compliance. Commitment to industry demonstrated through organizational and government regulatory contributions. Technical expertise and access to FDA thru professional relationships to implement successful audits and inspections, through full compliance, and approvals for product application regulatory approvals such as ANDAs and DMFs.SERVICES AND SPECIALTIES:Global manufacturing and laboratory plant audits for CGMP compliance and upgrade programs based on risk analysis. Evaluation of company procedures, policies and systems for compliance with FDA requirements. Personnel training programs evaluation and upgrade.Product registration for ANDAs and DMFs to expedite product development programs and marketing plans. Development and implementation of programs and schedules to meet objectives of virtual companies.Development and implementation of FDA and company compliant Standard Operating Procedures (SOPs) and other documentation for manufacturing and laboratory. Vendor audits and supply chain management.Evaluation of company systems and procedures for risk management and quality systems with establishment and implementation of upgrade programs.
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