Expert Quality Consulting & Technical Writing Services for the Pharmaceutical, Biologics, and Medical Device Industries.
Our Services
Commissioning, Qualification, & Validation
We prepare comprehensive protocols for Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring your operations are validated and trustworthy.
Batch Records
Our documents provide a thorough record of your processes, facilitate audits, and aid in troubleshooting, all while ensuring regulatory compliance. Choose us for reliable, accurate documentation that supports your commitment to exceptional product quality and safety.
Logbooks
From equipment maintenance and calibration records, to laboratory tests, quality control checks and more, we craft logbooks that support your operations, streamline auditing, and maintain your commitment to the highest levels of integrity and accountability.
Regulatory
Whether it’s Investigational New Drug (IND) applications, New Drug Applications (NDA), Clinical Study Reports (CSR), or Quality Agreement documents, we ensure precision, accuracy, and compliance. Our team is committed to producing high-quality, comprehensive submissions that facilitate your interactions with regulatory authorities.
Policy and Compliance
We tailor our writing to reflect your company’s values, while ensuring it aligns with the necessary guidelines, whether that’s FDA, EMA, ICH or others. Trust us to provide clear, accessible content that supports your commitment to maintaining industry best practices and the highest levels of compliance.
Standard Operating Procedures (SOPs)
Our team of expert technical writers meticulously develops SOPs, aligning them to FDA regulations and industry standards. We ensure your procedures are thorough, compliant, and tailored to your specific needs.
About Us
Our Mission: Our mission is to advance the quality, efficiency, and compliance of pharmaceutical, biologics, and medical device companies around the globe. Founded by a team of industry veterans, our company is dedicated to providing expert consulting and technical writing services that meet the unique challenges of your sector.
Our Expertise: With decades of combined experience, our team brings deep knowledge of the pharmaceutical and biotechnology industries, including regulatory landscapes, quality management systems, and product development cycles. Our professionals are not just consultants; they are industry experts who have been in your shoes and understand your needs.
Our Services: We specialize in transforming Centers of Excellence through meticulous consulting, from enhancing regulatory compliance and operational efficiency to integrating cutting-edge technologies. Our technical writing team excels in creating clear, compliant, and concise documents that are crucial for successful audits and streamlined processes.
Our Commitment: At CoGenyx, we are committed to the highest standards of excellence. We believe in a partnership approach, working closely with our clients to understand their challenges and goals. Our flexible, customized solutions are designed to fit your specific needs, ensuring you achieve and maintain industry-leading standards.
Our Vision: We envision a world where every pharmaceutical, biologic, and medical device company operates at its highest potential, with quality systems and products that exceed global standards. Our goal is to empower your team, enhance your operations, and ensure your success through our expert guidance and support.
Join Us: Partner with us and experience how CoGenyx can make a difference in your organization’s journey towards excellence. Let’s innovate, improve, and inspire together.