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. We are invested in every type of study, from variation in doses, dosage forms, single and double blind, dose escalation, PK/PD end point studies, glucose clamp studies, proof of concept and exploratory, repeat “first in man”, nutritional, special population, drug interaction, injection study, inhalation study to many more, and are dedicated to transforming healthcare.

We follow Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) and are ISO 9001-2015, ISO 27001-2013 certified for Quality Management System. Our clinical testing laboratories are The National Accreditation Board for Testing and Calibration Laboratories (NABL) and College of American Pathologists (CAP) certified. Our 3 Clinical Pharmacology Units have 208 beds to meet all your study needs. Our 2 state-of-the-art, GLP, 21 CFR Part 11 compliant labs house 12 triple quad mass spectrometers and 2 ICP-MS system.

Accreditation for Our Clinical laboratories

NABL (National Accreditation Board for Laboratories; ISO15189-2012)

CAP (College of American Pathologists)

Our facilities, systems and processes have been inspected successfully by

USFDA, WHO, EMA (ANSM/AGES), Thai FDA, NPRA & DCGI

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.

GAIN FROM NAVITAS LIFE SCIENCE’S INHALATION STUDY CAPABILITIES

• Dosing in segregated area & videography
• Negative air chambers to prevent cross contamination
• Canisters weighed before and after dosing
• Readily available bioanalytical methods for Mometasone, Fluticasone, Formoterol, Albuterol, Tiotropium and Ipratropium
• State of the Art instrumentation to ensure measurement of even lowest Lower Limit of Quantification (LLOQ) addressing dosing and pharmacokinetic needs
• Dedicated wet-lab and instrumentation room

Our dedicated well-trained team of bioanalytical scientists are specialized in developing sensitive and robust methods capable of providing quantitation at sub-picogram level, which is a critical attribute for the success for any inhalation study.

Bioanalytical Methods Developed for

• Mometasone (1pg/mL)
• Fluticasone (0.5pg/mL)
• Formoterol (0.4pg/mL)
• Tiotropium (0.5pg/mL)
• Ipratropium (0.5pg/mL)

• Vilanterol (1 pg/mL)
• Budesonide (10pg/mL)
• Beclomethasone dipropionate and monopropionate (10pg/mL)
• Albuterol (20pg/mL)

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).

The euglycemic clamp technique is the gold standard for assessing insulin sensitivity in humans. Demonstration of similarity Pharmacokinetic and pharmacodynamic profiles of the biosimilar with that of the reference (comparator) is considered the mainstay of proof of similarity in efficacy and safety of the biosimilar when compared to the reference.

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.

U.S. FDA Review

We have had multiple successful inspections over the last 10 years by global regulators including USFDA, DCGI, ThaiFDA, EMA (ANSM & AGES), and WHO.

In July 2022, we completed a successful US Food and Drug Administration (FDA) Inspection of our Manipal Clinical Facility, with no observations and, thereby, no 483s. It was indicated during the inspection that we were one of few organizations that strictly deployed COVID-19 preventive measures, while our approach of detailed investigation of events and deviations was also well appreciated. We provided seamless source data provision with scientific discussions and deliberations, which was appreciated by the inspector, culminating in the successful closeout.

Meet Dr. Ayaaz at the ET Health Summit

We are delighted that our Global Head Generics, Dr. Ayaaz Hussain Khan, will participate in this upcoming virtual roundtable, along with Dr. Ravi Sekhar Kasibhatta, SVP & R&D Head, Lupin Pharmaceuticals, Sumit Garg, Global CIO, Piramal Pharma, Anirban Roy Chowdhury, Vice President - Clinical Research Pharmacovigilance, Bharat Serums & Vaccines Limited, Mukesh Kumar, Senior Vice President & Head, Clinical R&D, Cipla, and Mark Lambrecht, Director, EMEA & APAC Health & Life Sciences,SAS, on Tue, 26 Jul, 2022 03:00 - 04:00 PM IST

Join the Session using the link provided here: https://health.economictimes.indiatimes.com/webinar/the-future-of-clinical-trials-challenges-opportunities/2244?redirect=1#overview_section

The Future of Clinical Trials: Challenges & Opportunities

As we emerge from the global COVID-19 pandemic, this event will explore the challenges faced, the lessons learned, and the successes gained in the field of Clinical Trials. Key discussion points include:

• Lessons learned while conducting clinical trials during the pandemic
• Decentralized clinical trials
• Technology adoption and organization restructuring for new age clinical trials
• Use of Real-World Data
• Integration of Cloud

For further information or to register your seat, please visit the event website: https://health.economictimes.indiatimes.com/webinar/the-future-of-clinical-trials-challenges-opportunities/2244?redirect=1#overview_section

Meet Dr. Ayaaz Hussain Khan at CPHI 2022

Navitas Life Sciences are excited to be back exhibiting with CPHI at the CPHI Frankfurt 2022 event taking place 01 – 03 November. Come and find us in the ICSE zone where our team of subject matter experts looks forward to meeting with you at booth 91H74.

If you would like to preschedule a time to meet with our team to discuss your key objectives and learn how we can help support your Generic Drug Development needs with our end-to-end services to help bring your product to market quickly and effectively please click here.

For further information about the event, please visit the CPHI website: https://www.cphi.com/europe/en/home.html

Current Trends in Pharmacogenomics that will shape Clinical Trials

Published in Pharma Focus Asia Issue 47 – 2022 | Pages 48 - 51

Pharmafocusasia

Download Now

Authored by

Dr. Ayaaz Hussain Khan,

Global Head of Generics,
Navitas Life Sciences

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