Six Secrets to why we are the Preferred CRO Partner for a Bioequivalence Study: Meet us at CPHI

Navitas Life Sciences is adept at identifying scientific and operational pain points, and utilizing its experience and expertise to enhance productivity and efficiency. Our Bioavailability & Bioequivalence team is experienced in delivering outcomes which are efficient, timely, high-quality, adhering to regulatory needs in fast track to achieve your first-to-market strategy.

1) End to end Services and Solutions for Generics Companies

At Navitas Life Sciences, our team of experts, are constantly optimizing, ideating, solving and developing new bioanalytical methods to cater to unique needs of sponsors, run efficient clinical studies with a focus on bringing scientific discovery as treatments to people who most need them.

2) Experts at Complex Studies:

We are preferred partners to deliver complicated studies with scientifically challenging methodologies such as NCE-1, FTF, multi-drug combination Inhalation studies, euglycemic clamp studies, PK/PD endpoint studies, PK studies with special population and patients, and more.

a. Euglycemic clamp studies: Navitas Life Sciences has extensive experience and expertise carrying out state of the art Euglycemic clamp studies, the gold standard for assessing insulin sensitivity in humans. The euglycemic clamp studies measure the glucose-lowering effect of biosimilar insulin compounds using a variable glucose infusion rate (GIR).

b. Efficient Total and Transferrin bound Iron assay for Iron Sucrose Formulations:

Navitas life sciences has developed robust methodologies for evaluating Iron-Carbohydrate preparations, leveraging our extensive knowledge about the complexities in iron sucrose preparations and the availability of the right resources. Our ability to find unique solutions to addresses customer expectations in a regulated bioanalysis environment aid us in bringing your iron preparation to the market faster.

c. Inhalation Studies Clinical Trials:

Inhalation offers a significant advantage over other methods of administration of medication as the drug is delivered directly to the lungs, which ensures a high concentration of the active ingredient at the site of action, and low systemic levels of the active ingredient.

3) Good record with Regulatory authorities:

Successful inspections by regulatory authorities with zero observations

4) State-of-the-Art GLP compliant Bioanalytical Labs:

We have state of the art GLP compliant Bioanalytical labs with 21CFR part 11 compliant LC-MS/MS systems. Bioanalytical Labs are equipped with 12 LC-MS/MS (02 AB Sciex 6500, 04 Waters Xevo TQ-S, 03 Thermo Ultra & 03 Thermo Discovery Max), ICP-MS (Agilent 7700x & 7900 in Class 10000 clean air lab facility), Roche COBAS-e411, Thermo Altis and Quantis.

5) Library of 400+ validated Assays:

Our methods library includes 400+ validated assays, with LCMS/MS for small and large molecule, and ICP-MS for trace elements. Our methods include precision levels of up to 0.4 pg/mL with 8 different matrices including bone and skin.

We have highly sensitive method for Mometasone (1 pg/mL), Fluticasone (1 pg/mL), Formoterol (0.4 pg/mL) & Tiotropium (0.5 pg/mL). Our expertise in macromolecules include Insulin, Glargine and its metabolites, Octreotide, Teriparatide, Liraglutide, C-peptide and more.

6) Good and varied governance systems:

Multiple governance system ensures adherence to regulatory guidelines

• Independent QA department with Standard Operating Protocols(SOP), training and audits
• Pre-conduct study approval by Manipal Academy of Higher Education Ethics Committee – India’s 1st Association for Accreditation of Human Research Protection Programs (AAHRPP)
• Accredited Ethics Committee (EC) and similar competent DCGI registered Independent Ethics Committee (IECs)
• Periodic certification to ISO 9001, ISO 27001, ISO 15189, CAP
• Self-identification with USFDA

CPHI Frankfurt 2022

Date: 01 – 03 November, 2022

Venue: Messe Frankfurt

Booth: 91H74

Navitas Life Sciences are excited to be back exhibiting with CPHI at the CPHI Frankfurt 2022 event taking place 01 – 03 November 2022.

Schedule a Meeting Now

Meet our Experts

Dr. Ayaaz Hussain Khan

Global Head of Generics
Navitas Life Sciences

Dinesh Prabhu

Associate General Manager, BABE Services
Navitas Life Sciences

To learn more about our services and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it.