Empowering Analytical Excellence
IQB Analytical Consulting LLC
A science-driven pharmaceutical and biopharmaceutical consulting company specializing in Analytical Development, Quality (CMC) documentation, and Regulatory Compliance.
Bridging Science and Compliance
IQB Analytical Consulting LLC was founded to meet the growing need for independent, expert-level analytical and regulatory consulting that bridges the gap between laboratory science and regulatory expectations. With over 20 years of hands-on analytical experience in R&D and GMP environments, we provide science-driven analytical and regulatory consulting tailored for method development, validation, impurity profiling, stability studies, and CMC documentation aligned with ICH and FDA guidance.
Expert Solutions
At IQB Analytical Consulting LLC, we offer a wide range of services designed to empower pharmaceutical and biopharmaceutical organizations with science-based, regulatory-compliant analytical solutions. Our services ensure product quality, safety, and success in global regulatory submissions, providing our clients with the confidence to accelerate development.
Analytical & CMC Consulting
Our Analytical & CMC Consulting services include stability-indicating HPLC/UPLC method development and validation for small molecules, peptides, and biologics. We also offer cleaning verification and validation protocol design, impurity and degradant profiling, forced degradation and stress study design per ICH Q1A(R2), analytical method lifecycle management, and QbD/AQbD framework development. Additionally, we provide CMC documentation preparation for IND, NDA, ANDA, and 505(b)(2) submissions, as well as analytical data review, trending, and risk-based control strategy design. We also offer vendor, lab, and CDMO analytical data review and technical support.
Regulatory & Quality Documentation
Our Regulatory & Quality Documentation services include authoring and reviewing Module 3 (Quality/CMC) sections of CTD, preparing and reviewing analytical method validation reports and summary tables, conducting nitrosamine risk assessments per ICH M7(R2), and creating cleaning validation protocols and COI documentation. We also assist in the preparation of technical responses for FDA deficiency letters.
Training & Compliance Support
Our Training & Compliance Support services include on-site or virtual training on method development, OOS/OOT investigations, and ICH compliance. We also conduct analytical troubleshooting and root cause analysis workshops, and provide laboratory audit readiness and technical gap assessments.
Customized Solutions
At IQB Analytical Consulting LLC, we understand that each client has unique needs. Therefore, we provide customized documentation and method strategies tailored to each client’s specific requirements. We place a strong focus on data integrity, traceability, and regulatory defensibility, ensuring that our solutions not only meet but exceed regulatory standards.
Why Choose IQB Analytical Consulting LLC
IQB Analytical Consulting LLC stands out in the industry due to our unique blend of scientific excellence and regulatory clarity. We have a deep understanding of FDA, ICH, and EMA regulatory frameworks, and hands-on expertise across a wide range of pharmaceutical modalities. This combination allows us to provide our clients with solutions that are both scientifically robust and compliant with regulatory standards.
Proven Record
With over 20 years of experience in the industry, we have a proven record of successful NDA/ANDA/IND submissions. Our extensive experience and deep industry knowledge enable us to guide our clients through the complex regulatory submission process, helping them avoid common pitfalls and achieve their goals.
Practical Approach
Our consulting approach is practical and result-oriented. We draw on our real-world lab and CMC experience to provide our clients with solutions that are not only technically sound but also feasible to implement. We understand the challenges that our clients face in the lab and in the regulatory environment, and we tailor our solutions to meet these challenges.
Commitment to Core Values
At IQB Analytical Consulting LLC, we are committed to our core values of Integrity, Quality, and Biopharma. These values guide everything we do, from the services we provide to the way we interact with our clients. We believe that by adhering to these values, we can provide our clients with the highest level of service and help them achieve their objectives.
Get in Touch
Reach out to IQB Analytical Consulting LLC today. We are here to empower your organization with science-based, regulatory-compliant analytical solutions that ensure product quality, safety, and success in global regulatory submissions. Whether you need assistance with method development, validation, impurity profiling, stability studies, or FDA submission documentation, our team of experts is ready to help.
Email: info@iqbanalyticalconsultingllc.com
Phone: +1 (845) 347-8599
Mailing Address: 116 Agnes Rd, Suite 200, Knoxville, TN 37919, USA
Business Hours:
Monday–Friday: 9:00 AM – 6:00 PM (CST)
Saturday–Sunday: Closed
We look forward to hearing from you and assisting you with your analytical and regulatory needs.