Alera Labs, LLC

Why is analytical testing crucial for pharma startups? Bringing a new drug to market is a complex and highly regulated process. Analytical testing ensures compliance with industry standards, product safety, and manufacturing efficiency—all critical factors for success. At Alera Labs, we provide expert stability studies, impurity testing, and comprehensive analytical support to help startups navigate regulatory requirements and optimize their formulations. Whether you need method development, validation, or routine analysis, our team is here to support your drug development journey. Partner with us to ensure quality and compliance every step of the way! Learn more: www.aleralabs.com #PharmaTesting #DrugDevelopment #AleraLabs #AnalyticalTesting #PharmaStartups

The Role of Analytical Testing in Drug Stability Studies: Drug stability testing is a critical part of the development process. It ensures that a drug maintains its intended efficacy, safety, and quality throughout its shelf life. Analytical testing methods, including high-performance liquid chromatography (HPLC) and mass spectrometry (MS), are essential to assess the stability of active pharmaceutical ingredients (APIs) and final drug products. These tests can identify degradation products, monitor physical changes, and determine storage conditions that preserve the drug’s integrity. At Alera Labs, we provide comprehensive stability studies with precise, reliable data to support regulatory submissions. Our cutting-edge instruments and expert team help pharmaceutical companies ensure that their products are safe, effective, and compliant. Learn more about our stability testing services: www.aleralabs.com #DrugStability #PharmaTesting #RegulatorySupport #AleraLabs

"Alera Labs' expertise and responsiveness have been invaluable to our drug development process. Their precision and reliability make them a trusted partner." – Dr. Davis Learn more: www.aleralabs.com ?#ClientSuccess #TrustedLab #AleraLabs

A recent project at Alera Labs required us to analyze stability samples for a novel drug formulation targeting a complex therapeutic area. The client, a pharma startup, was facing a tight timeline for FDA submission, and the stability of the drug was crucial for ensuring its long-term efficacy. Our team utilized high-resolution chromatography and mass spectrometry to assess the stability of both the active pharmaceutical ingredient (API) and the finished drug product. With our precise, reliable methods and fast turnaround, we provided data that enabled the client to stay on track and meet critical submission deadlines. At Alera Labs, we pride ourselves on delivering timely and accurate results to help clients succeed in their regulatory journey. Need support with stability studies or other analytical services? Let’s talk: www.aleralabs.com ?#PharmaStartups #StabilityTesting #FDAApproval #AleraLabs

Advances in mass spectrometry (MS) are transforming bioanalysis, making drug development faster and more precise. Recent innovations, such as high-resolution MS and hybrid instruments, push detection limits lower than ever, improving sensitivity for complex biological matrices. At Alera Labs, we integrate these cutting-edge technologies to provide high-quality, reliable data that supports regulatory submissions. Want to leverage advanced bioanalysis for your project? Learn more: www.aleralabs.com #MassSpectrometry #Bioanalysis #DrugDevelopment #AleraLabs

Reliable analytical support can make all the difference in a successful drug development program. At Alera Labs, we take pride in delivering high-quality data, fast turnaround times, and expert guidance that our clients can trust. Here’s what one of our recent partners had to say about working with us: "Alera Labs has been instrumental in our analytical needs. Their expertise in bioanalysis, rapid method development, and regulatory compliance helped us generate high-quality PK and TK data for our investigational drug. The team’s attention to detail, responsiveness, and scientific rigor ensured that our study remained on track and met critical regulatory deadlines." – Dr. Jones Why do pharma startups, biotech companies, and consultants trust Alera Labs? ? Expertise in Bioanalysis – We provide high-sensitivity detection and quantification of drug compounds and metabolites using advanced LC-MS/MS techniques. ? Regulatory-Ready Data – Our validated methods meet FDA and EMA guidelines for compliance and accuracy. ? Fast Turnaround – We understand that time is critical, and we deliver results quickly without compromising quality. ? Personalized Support – We work closely with our clients to address their unique analytical challenges. If you need a dependable analytical partner to support your drug development program, let’s start a conversation today! Visit us at www.aleralabs.com. #ClientSuccess #TrustedLab #PharmaStartups #Bioanalysis #DrugDevelopment #RegulatoryCompliance #AnalyticalChemistry

Need high-quality analytical support? Visit www.aleralabs.com or contact us at (919) 391-0090 to discuss how Alera Labs can help your next project succeed! #AnalyticalChemistry #DrugDevelopment #Bioanalysis #Pharma #RegulatoryCompliance #MassSpectrometry #HPLC #MethodValidation

At Alera Labs, we take pride in helping pharmaceutical startups navigate complex analytical challenges. Recently, we partnered with a biotech company developing a novel small-molecule drug candidate. They needed precise quantification of their compound and its metabolites in plasma samples to meet FDA regulatory requirements for their IND submission. Leveraging our advanced LC-MS/MS platform, we developed and validated a bioanalytical method with a lower limit of quantification (LLOQ) in the low pg/mL range. This level of sensitivity was crucial for accurately assessing the pharmacokinetics (PK) of the drug at therapeutic and sub-therapeutic doses. Our streamlined approach enabled us to deliver high-quality data within just 10 business days, helping the client meet critical regulatory deadlines. By ensuring accuracy, compliance, and rapid turnaround, we empowered our client to move forward with confidence in their drug development process. If you're looking for a trusted partner in bioanalysis, let's discuss how Alera Labs can support your next project! For more information, visit www.aleralabs.com or reach out to us today! #PharmaStartups #Bioanalysis #AnalyticalChemistry #DrugDevelopment #RegulatoryCompliance #LCMS

Pharmacokinetics (PK) and toxicokinetics (TK) studies are essential for evaluating how a drug moves through the body and its potential toxicity. Accurate bioanalysis plays a crucial role in these studies, ensuring reliable data for regulatory submissions. At Alera Labs, we specialize in high-precision bioanalytical techniques, using advanced instrumentation to quantify drug concentrations, metabolites, and biomarkers in biological matrices. Whether you're in early-stage development or preparing for clinical trials, our expertise ensures data integrity and compliance with regulatory standards. Partner with us for dependable analytical support! For more information, visit www.aleralabs.com or reach out to us today! #Pharma #Bioanalysis #DrugDevelopment #Pharmacokinetics #Toxicokinetics