We specialize in providing top-notch bioequivalence studies that play a crucial role in ensuring the safety and efficacy of generic pharmaceutical products. Our dedicated team of experts, cutting-edge facilities, and commitment to scientific excellence make us a trusted partner for pharmaceutical companies seeking to demonstrate the equivalence of their generic products to their brand-name counterparts.
Clinoquent Research Pvt Ltd has expanded its proficiency in Bioequivalence and bioanalysis services to encompass a diverse array of clinical research offerings. Our achievements are propelled by our dedication to assisting clients with a comprehensive grasp of the crucial significance of time, project management, and adherence to GCP & GLP regulations. Our core asset lies in our assembly of principled, adept, well-informed, and customer-centric experts.
What are Bioequivalence Studies?
Bioequivalence studies are a pivotal component of the drug development and regulatory process. They are conducted to establish that a generic pharmaceutical product performs in the same manner as its reference (innovator) product. These studies compare the pharmacokinetic parameters of the generic product and the reference product to ensure that they are essentially the same. Bioequivalence studies are required by regulatory authorities to guarantee the interchangeability and therapeutic equivalence of generic drugs, providing patients with access to safe and effective treatments at lower costs.
Why Choose Us for Bioequivalence Studies?
Our Bioequivalence Study Services:
Oral Solid Dosage Forms: From tablets to capsules, we conduct a comprehensive range of studies to demonstrate bioequivalence in oral solid dosage forms.
Injectables and Parenterals: Our expertise extends to injectable drug products, including solutions, suspensions, and emulsions.
Topical Formulations: We perform studies on creams, ointments, gels, and other topical products to validate their bioequivalence.
Respiratory Products: Inhalers and nasal sprays undergo rigorous testing to ensure their therapeutic equivalence.
Biopharmaceuticals: Our capabilities also encompass complex biopharmaceuticals, demonstrating bioequivalence for biosimilars and biologics.
Bioanalytical Lab offers comprehensive bioanalytical services for small molecule development including:
Our bioanalytical facility is well equipped with highly sophisticated instruments and multiple state-of-the-art resources, ensuring a straightforward and compliant submission for any country. The team comprises of well-trained and experienced Scientists. Our comprehensive analytical SOPs ensure compliance with good laboratory practice (GLP) and current regulatory guidance documents.
Our expertise, combined with our state-of-the-art instrumentation, allows us to achieve:
We can perform assays for over 150,000 samples per year, many for multiple analytes and comprising parent drugs and several metabolites in one single assay. Sample analysis is performed for projects carried out in our own clinics as well as for external projects.
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When it comes to demonstrating the bioequivalence of your generic pharmaceutical products, Clinoquent Research Pvt Ltd is your reliable partner. We combine scientific expertise, advanced facilities, and regulatory know-how to deliver results that matter. Contact us today to discuss your bioequivalence study needs and embark on a journey towards drug development success.