Pharmaceutical & Biologics Quality Assurance Support
A Perfect partner who offers support to ensure your product’s quality
Elexes is one of the trusted partners for Biologics and Pharmaceutical Quality Assurance for several renowned pharmaceutical companies. Quality assurance is an essential aspect in the pharmaceutical industry that ensures the safety, efficacy, and regulatory compliance of your products.
Our Biologics & Pharmaceutical Quality Assurance service is designed to support you in establishing and maintaining a robust Quality Management System (QMS), preparing and revising corporate Standard Operating Procedures (SOPs), conducting GxP audits, creating quality agreements and manuals, and providing essential QA reviews for various documents, all of which contribute to your pharmaceutical company's success
Why do you need Quality Assurance support?
Quality assurance in the pharmaceutical sector is not just about meeting regulatory requirements; it's about ensuring patient safety and product effectiveness. A strong quality assurance program is the backbone of your biologics & pharmaceutical operations. With our professionals you get the best biologics & Pharmaceutical Quality Assurance service that offers a comprehensive range of solutions to ensure that your products consistently meet the highest standards of quality and compliance.
Quality Management System (QMS) Development
We work with you to establish and enhance a comprehensive Quality Management System that aligns with regulatory standards. A well-designed QMS is vital for maintaining product quality, regulatory compliance, and continuous improvement.
Preparation/Revision of Corporate SOPs
Our experts assist in developing, updating, or revising Standard Operating Procedures (SOPs) tailored to the stage of product development. Well-defined SOPs are crucial for consistency, compliance, and operational efficiency.
GxP Audits: Vendors, Suppliers, Study Sites
We conduct thorough audits of vendors, suppliers, and clinical study sites to assess their compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant GxP regulations.
Establishment of Quality Agreements and Manuals
We help you create quality agreements and manuals for effective collaboration with suppliers and partners, ensuring a shared commitment to quality and regulatory compliance.
QA Review of Documents
Our team conducts comprehensive reviews of critical documents, including master/executed batch records, specifications, test methods, validation and stability protocols, and reports to ensure accuracy, compliance, and consistency.
PAI Readiness Assessment and Training
We assess your readiness for Pre-Approval Inspections (PAI) by regulatory agencies and provide tailored training to help your team prepare for successful inspections.
Customized Quality Assurance Solutions
We create customized quality assurance solutions to meet your specific needs, ensuring that you receive support tailored to your unique situation.
Associated Regulatory Authorities.
Our team of biologics & pharmaceutical quality assurance professionals has extensive knowledge of regulatory standards and industry best practices.
We understand that each pharmaceutical & biologics operation is unique, and we tailor our services to your specific needs.
Why Choose Elexes?
We work diligently to provide timely and effective quality assurance support, ensuring that your products meet the highest standards.
Our comprehensive assessments and recommendations help you maintain compliance and avoid potential legal issues.
We handle your sensitive information with the utmost confidentiality and adhere to strict privacy standards.
Amazing Feedback Say About Services
CEO Masterlink, Arizona
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President ViDava, Florida
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Manager Outset Medical, California
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MD Blackrock Pharma, England
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Owner Liz Inc., Arizona
CEO Radformation, New York