CLINOQUENT

Bioequivalence & Bioanalytical Services

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Welcome to Our Bioequivalence Studies Services

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?

  1. Scientific Excellence: Our team of experienced scientists and researchers are well-versed in the intricacies of bioequivalence studies. We adhere to the highest scientific standards to ensure accurate and reliable results that withstand regulatory scrutiny.
  2. State-of-the-Art Facilities: We boast state-of-the-art facilities equipped with advanced analytical instruments and technology, enabling us to conduct a wide range of bioequivalence studies across various drug formulations.
  3. Regulatory Expertise: Navigating the regulatory landscape can be challenging. Our regulatory experts are well-versed in the guidelines set forth by various regulatory authorities. We help you streamline the approval process by ensuring your studies are designed and executed in accordance with the latest requirements.
  4. Tailored Study Designs: We understand that each drug formulation is unique. Our team works closely with you to develop a customized study design that meets your specific requirements while adhering to regulatory guidelines.
  5. Timely Execution: We value your time. Our efficient project management ensures that your bioequivalence studies are conducted promptly without compromising on the quality of results.
  6. Data Integrity: We uphold the utmost integrity in data collection, analysis, and reporting. You can trust that your study results will be accurate, transparent, and scientifically sound.
 

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.

Welcome to Our Bioanalytical Services Services

Bioanalytical Lab offers comprehensive bioanalytical services for small molecule development including:

  • Pharmacokinetic (PK) Analysis
  • Bioavailability Studies
  • Bioequivalence Studies
  • Drug Interaction Studies
 

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:

  • Extremely low LLOQ
  • Wide linearity range
  • Analysis of multiple drugs/metabolites in a single method
  • Analysis from various biological matrices
  • Quick method development
 

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.

 

Archival

  • Inhouse archival facility with about 1,500 sq. ft.
 

Our Strength

  • Utilizing cutting-edge infrastructure equipped with modern instruments adhering to GxP standards, we ensure project completion with the highest efficiency and uncompromised quality.
  • Our specialized R&D unit boasts extensive expertise in formulation development, analytical research, and bioequivalence studies. This team comprehends your objectives while prioritizing innovation and cost-effectiveness.
  • Our proficiency leads to swift project turnaround times, optimizing both time and expenditure, supported by our technical prowess.
  • Our seasoned experts guarantee compliance with global regulatory requirements through their wealth of experience.
  • We prioritize customer contentment by upholding confidentiality, accountability, integrity, quality, and prompt project completion.

Clinical Services

Facility

  • Spacious clinical ward with an area of about 10,000 sq. ft.
  • One fully equipped 2 bed ICU
  • State-of-the-art two identical clinical wards of 36 beds each comprise total beds to 72
  • Proximity to a hospital that will facilitate quicker and better handling of emergencies
  • Pharmacy with controlled access
  • Counselling room with audio-video recording facility
  • Emergency calling point at a bed and in washroom
  • A recreational facility for subjects during the study
  • Dedicated nurse/lab technician for sample withdrawal and care
  • Volunteers’ data bank for recruitment of healthy human volunteers
  • -800C deep freezers for plasma sample storage which are continuously monitored through a data logging system

Expertise

  • Can Conduct studies in different Therapeutic areas like, lipid-lowering agents, anti-diabetics, antidepressants, Antibiotics, NSAIDs, antiepileptics, muscle relaxants, cardiac drugs, Herbal and Nutraceuticals etc.
  • Experienced in the conduction of ‘Onco’ Products on healthy volunteers
  • Experienced in the conduction of a ‘Cardiac Monitor’ study on healthy volunteers
  • Studies performed on different formulations like, Tablet, Capsules, Syrups, Suspension, IV, Sprays etc.
  • Can handle male and female volunteers’ studies simultaneously
  • Lead time to finalization of documents is much less
  • Submission of reports in eCTD formats

Contact Us Today

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.