Alex Kazandjian
Vice President (Sales &Marketing)
As the pharmaceutical industry continues to shift toward complex, niche therapeutics and accelerated development timelines, the demand for specialized reference standards is rapidly increasing. These highly specific materials, including drug impurities, metabolites and their stable isotope-labeled counterparts, as well as proprietary compounds, are essential for ensuring data integrity, supporting regulatory submissions, and driving innovative drug development.
At the forefront of this evolving landscape is TLC Pharmaceutical Standards, a company that has established itself as a trusted partner for high-quality custom synthesis. Known for its deep scientific expertise, end-to-end in-house operations, and unwavering commitment to quality, the company is helping to redefine what pharmaceutical companies should expect from their reference standard provider.
Rising Demand, Rising Standards
The modern pharmaceutical environment demands not only speed but precision. As drug development becomes more tailored and technically complex, companies require reference materials that are not only chemically accurate but also analytically robust and regulatory-ready. At TLC Pharmaceutical Standards, these expectations are met through a combination of advanced synthetic capabilities, comprehensive analytical testing, and strict quality control protocols, all managed entirely under one roof. “In our experience as a reference standards manufacturer, we’re seeing a clear shift toward more customized and scientifically demanding compounds. We’re not just producing molecules, we’re enabling our clients’ success by ensuring they have the precise materials needed for method development, validation, and compliance”, says Alex Kazandjian, Vice President (Sales & Marketing), TLC Pharmaceutical Standards. What differentiates TLC Pharmaceutical Standards is its full-spectrum control of the synthesis and characterization process. Rather than outsourcing stages of production or parts of the characterization, the company maintains everything inhouse, from initial design to final release, allowing for rigorous quality assurance, consistent timelines, and complete traceability. Every compound is confirmed using orthogonal techniques such as NMR, LCMS, FTIR, and HPLC/UPLC, while supported by transparent documentation that instills confidence in both scientific and regulatory environments.
From Supplier to Strategic Partner
The pharmaceutical sector is transitioning from transactional sourcing to strategic partnerships, and TLC Pharmaceutical Standards is leading that charge. As clients increasingly seek fit-for-purpose standards to meet specific project goals, the company’s role evolves from that of a conventional supplier to a scientific collaborator.
Alex explains, “Many of our clients now come to us at the very early stages of development. Sometimes, they don’t even have a defined compound, they’ve observed an unknown degradation product or an unidentified impurity. We help them identify the structure, synthesize the compound, and provide a fully characterized reference standard”. This consultative approach is supported by confidentiality frameworks such as CDAs and NDAs, which allow clients to share internal data safely and confidently. It’s a relationship built on trust, one that enables the scientific rigor and responsiveness that modern drug development demands.
Setting the Bar for Quality & Compliance
TLC Pharmaceutical Standards operates in full alignment with internationally recognized quality standards, including ISO 9001, ISO/IEC 17025, and ISO 17034. These certifications aren’t just checkboxes, they’re embedded in the company’s DNA. ISO 9001 ensures that TLC’s quality management systems meet both customer and regulatory expectations. Furthermore, ISO/IEC 17025 validates the technical competence of TLC Pharmaceutical Standards' analytical methods. And lastly, ISO 17034 confirms the company’s reliability and traceability as a producer of reference materials.
“These standards guide every decision we make, from training and documentation to continuous process improvement. They allow us to maintain scientific excellence while fostering accountability and transparency”, signifies Alex.
The Speed-Quality Balance
While speed is critical in the pharmaceutical industry, TLC Pharmaceutical Standards firmly believes it should never come at the expense of quality. That balance is achieved through deep technical expertise, robust project management, and clear, transparent communication. Alex also highlights, “Our experience in diverse reaction types and purification strategies allows us to move quickly without cutting corners. But we are honest about timelines and challenges. We never promise what we can’t deliver, and we never release a product until we are 100 percent confident in its identity and purity”.
This honesty and rigor have become defining features of the TLC Pharmaceutical Standards brand and key reasons clients continue to return, even when facing the most complex synthesis challenges.
Investing in Peptide Capabilities
TLC Pharmaceutical Standards has also made strategic investments in response to rising interest in peptide-based drugs. The company has onboarded experts in peptide chemistry and built a dedicated lab for peptide synthesis, enabling it to meet increasing demand for peptide standards, related impurities, and labeled analogs.
A standout example is the company’s extensive portfolio within the GLP-1 class of peptides, including Semaglutide, Liraglutide, and related compounds. These products are developed with the same level of analytical rigor and quality control that defines the company’s broader service offering, ensuring they meet the needs of clients navigating this growing therapeutic category. Alex adds “Peptides are complex, but our team’s expertise allows us to deliver highquality materials with consistency and speed. It’s become a cornerstone of our services”.
Sustainability & Green Chemistry
As environmental concerns take center stage in global healthcare, TLC Pharmaceutical Standards is embracing green chemistry principles in its synthetic processes. This includes minimizing hazardous waste, using safer reagents and solvents, and optimizing reactions for efficiency and sustainability.
As the pharmaceutical industry continues to evolve, one thing remains certain, that TLC will be there, delivering highquality, custom reference standards with precision, integrity, and a steadfast commitment to excellence
Alex Kazandjian, Vice President (Sales &Marketing)
Beyond reaction design, the company enforces strict waste segregation, neutralization, and disposal protocols, further reducing its environmental footprint. “Sustainability isn’t an afterthought for us. It’s built into how we design and run our processes”, says Alex.
Analytical Excellence in a Data-Driven World
In an increasingly data-driven pharmaceutical environment, regulatory scrutiny of documentation is more intense than ever. TLC Pharmaceutical Standards addresses this challenge through rigorous adherence to GLP and GxP principles. From raw data acquisition to final reporting, every analytical step is documented with precision, transparency, and full traceability. “Our documentation doesn’t just meet requirements, it supports decision-making. We maintain meticulous records that support audits, reproducibility, and submission success”, signifies Alex.
Protecting Client IP with Rigid Confidentiality
Custom synthesis often involves highly proprietary information, and TLC Pharmaceutical Standards treats intellectual property protection with the gravity it deserves. The company enforces strict internal and external confidentiality protocols, including detailed Non-Disclosure Agreements, secure digital infrastructure with encrypted systems and access controls, project-specific workflows to prevent cross-contamination, regular training for staff on data privacy and security, and routine audits to proactively identify and mitigate risks.
Alex further emphasizes, “Our clients trust us with some of their most valuable intellectual property. We’ve built our systems and our culture around protecting that trust”.
Strategic Growth: A Future Built on Flexibility
Looking ahead, TLC Pharmaceutical Standards' strategic vision is clear, which is to stay agile, stay responsive, and continue to lead with science. The company’s streamlined organizational structure and entrepreneurial mindset enable it to rapidly adjust to shifting market demands, whether that’s new regulatory requirements, emerging therapeutic classes, or novel synthesis techniques. Alex further shares, “Our team is our greatest asset. We’ve built a network of industry experts who are not only technically excellent but also passionate about solving hard problems. That’s how we continue to grow, by being ready for what’s next”.
Built on Trust, Driven by Science
At the core of TLC Pharmaceutical Standards is a philosophy that prioritizes substance over style. While many companies focus on bold marketing, TLC Pharmaceutical Standards quietly delivers on what matters most, which is scientific integrity, unmatched quality, and client trust. “Our tagline, ‘Your Trusted Source for Reference Standards’, isn’t just a slogan, it’s a commitment. We’ve grown because our clients know we’ll deliver the quality they need, every time. That’s what sets us apart”, concludes Alex.