Team Elexes 
Elexes Team 
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.
Our Services
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Quality Management System (QMS) Development
We work with you to establish and enhance a comprehensive Quality Management…
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Preparation/Revision of Corporate SOPs
Our experts assist in developing, updating, or revising Standard Operating Procedures (SOPs)…
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GxP Audits: Vendors, Suppliers, Study Sites
We conduct thorough audits of vendors, suppliers, and clinical study sites to…
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Establishment of Quality Agreements and Manuals
We help you create quality agreements and manuals for effective collaboration with…
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QA Review of Documents
Our team conducts comprehensive reviews of critical documents, including master/executed batch records,…
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PAI Readiness Assessment and Training
We assess your readiness for Pre-Approval Inspections (PAI) by regulatory agencies and…
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Customized Quality Assurance Solutions
We create customized quality assurance solutions to meet your specific needs, ensuring…
Read MoreQuality 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.
Expertise
Our team of biologics & pharmaceutical quality assurance professionals has extensive knowledge of regulatory standards and industry best practices.
Customized Solutions
We understand that each pharmaceutical & biologics operation is unique, and we tailor our services to your specific needs.
Why Choose Elexes?
Efficiency
We work diligently to provide timely and effective quality assurance support, ensuring that your products meet the highest standards.
Compliance Assurance
Our comprehensive assessments and recommendations help you maintain compliance and avoid potential legal issues.
Confidentiality
We handle your sensitive information with the utmost confidentiality and adhere to strict privacy standards.
Clients Testimonials
Amazing Feedback Say About Services
Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
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Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
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Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
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Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
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Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
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Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
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Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
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Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
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