Pharmaceutical Quality Assurance

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

Preparation/Revision of Corporate SOPs

Our experts assist in developing, updating, or revising Standard Operating Procedures (SOPs)…

GxP Audits: Vendors, Suppliers, Study Sites

We conduct thorough audits of vendors, suppliers, and clinical study sites to…

Establishment of Quality Agreements and Manuals

We help you create quality agreements and manuals for effective collaboration with…

QA Review of Documents

Our team conducts comprehensive reviews of critical documents, including master/executed batch records,…

PAI Readiness Assessment and Training

We assess your readiness for Pre-Approval Inspections (PAI) by regulatory agencies and…

Customized Quality Assurance Solutions

We create customized quality assurance solutions to meet your specific needs, ensuring…

Quality Management System (QMS) Development

We work with you to establish and enhance a comprehensive Quality Management…

Expertise

Our team of pharmaceutical quality assurance professionals has extensive knowledge of regulatory standards and industry best practices.

Customized Solutions

We understand that each pharmaceutical 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.

Learn More

Contact us today to discover how our Pharmaceutical Quality Assurance service can help you ensure the quality, safety, and regulatory compliance of your pharmaceutical products.

Request a Consultation

Associated Regulatory Authorities.

We’ve More
Then 2563+ Global Clients

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 _“

Diane Bryant

CEO Novasignal, Los Angeles

^“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process. _“

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. _“

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. _“

Joshua Mink

Manager Outset Medical, California

^“Highly recommend Elexes! They always meet commitments and follow through on action items. _“

Michal Depa

CTO Jana Care, Massachusetts

^“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly. _“

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. _“

Samip Shah

VP Regulatory AliveCor, California

^“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise. _“

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. _“