Secrets to How Our Rescue Trial for a Global Pharma Received FDA Approval

Navitas Life Sciences has always focused on quality and consistency, relying on its vast experience, expertise, and technology support to become the preferred strategic partner for numerous global Pharma and Life Sciences companies.

We have proven expertise in a wide variety of generics studies which include variation in doses, dosage forms, single and double-blind, dose-escalation, PK/PD endpoint studies, Glucose clamp studies, proof of concept and exploratory, repeat “first in man,” nutritional, special population, drug interaction, injection study, inhalation study and many more.

1400+

BABE Studies Conducted

350+

Bioanalytical Methods Developed

100+

Marketing Authorizations

High Quality Labs to Conduct Generics Studies

IDMP We ensure that your phase 1 / bioequivalance study is conducted with the highest level of compliance to regulatory requirements. We have invested in and built up the necessary expertise and infrastructure to ensure that your biosimilar product is launched quickly. With our extensive experience, we understand and have mastered the challenges of deploying the appropriate study design to effectively and scientifically bring your drug product to market.

Our labs are accredited with the Indian national agency NABL (National Accreditation Board for Testing and Calibration Laboratories) as well as international accreditation from CAP (The College of American Pathologists) since 2007.

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

The NABL and CAP audits occur biannually, and we have been audited by both agencies since 2007 without any major observation. The regulatory audits by health authorities like USFDA occur every three years, with sponsor audits happening quite frequently.

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 1 ICPMS.

ICP-MS Instrumentation

Agilent 7700 and 7900 series

Application software

ICP-MS Mass Hunter G7201C C.01.05

Integrated with OpenLab ECM 3.6 for 21CFR part 11 compliance

Get Yourself the Navitas Life Sciences Advantage

  • Experienced expert physicians from the tertiary care hospital to manage safety related Concerns
  • Trained investigators and nursing staff
  • Qualified, 21CFR Part11 compliant analyzer with redundancy
  • Expertise in handling all dosage formulations
  • LCMS-MS method for bioanalysis
  • Validated methods for peptides- Very Low LLOQ
  • ECLIA methods for Insulin and C-Peptide

Rescue trial for a Global Pharma

IDMP

Recently a global Pharma required expert support to conduct a rescue trial for a drug product that helped reduce symptoms of menopause for women.

The global pharma required Navitas Life Sciences to conduct the study on priority. We understand the strategic importance of delivering high-quality studies, which is why we have an impressive record with the FDA.

“Navitas Life Sciences is proud to have leveraged its expertise and experience in this Transdermal Patch Pharmacokinetic/Pharmacodynamic (PK/PD) biostudy enabling the sponsor for a quicker approval from the US FDA agency, eventually benefiting women patients in reducing menopausal symptoms.”

Dr. Ayaaz Hussain Khan

Global Head - Generics,

Navitas Life Sciences

To understand more about the study and the extent of support provided, we met with Dr. Vasudev Shenoy, Assistant Vice President - BA/BE Services, Navitas Life Sciences.

Tell us about your professional journey

I completed my Doctorate in Pharmaceutical sciences specializing in Clinical pharmacokinetics from the Manipal Academy of Higher Education, Manipal and I have 16 + years of experience in the field of Phase 1 and Bioavailability and Bioequivalence Clinical Studies. I started my career as a Clinical Research Associate in a Hospital based Site Management Organization (SMO) supporting clinical trials for Pharmaceutical Companies and then joined the Manipal Ecron Acunova (Now Navitas Life sciences). I was initially responsible for managing the conduct of Bioequivalence studies.

My Core strength is in Designing, Managing, and conducting Phase 1 and Bioavailability and Bioequivalence studies. I have handled more than 500+ end-to-end and supported more than 1000+ clinical studies on healthy subjects, including Phase 1, BA/BE, and Drug-Drug Interaction Studies for Various Regulatory submissions Viz USFDA, EMA, Health Canada, NPRA, WHO, GCC, and CDSCO at Navitas Life Sciences.

I have also been a part of various regulatory inspections with both national and global Regulatory agencies. I also have extensive experience in handling applications for BA/BE and Phase 1 healthy subject studies for approval from CDSCO, MoH, Govt of India.

Dr. Vasudev Shenoy

Assistant Vice President,
BA/BE Services,

Navitas Life Sciences

Currently I am the Assistant Vice President – BA/BE Services and I head the Project Management and Regulatory services for the Generics Division across all our locations viz Manipal, Mangalore, Bangalore and Chennai.

What is the nature of the drug under study and who are the likely people to benefit from the drug?

The Drug molecule we studied is a Hormonal preparation through a Transdermal Delivery system. This is indicated in Post -Menopausal Women to help reduce symptoms of menopause (Moderate to Severe Vasomotor Symptoms Due to Menopause).

What were the challenges faced during the study?

The study was performed on healthy post-Menopausal women. There were certain challenges faced during study participant recruitment due to stringent inclusion and exclusion criteria, with multiple tests (PAP Smear, Mammogram, Beta-HCG) other than routine tests as criteria for enrollment and with patch adherence test post application.

How long did it take to complete the study?

This study was a top priority for the client, and the entire study, including the DCGI BENOC application, protocol development, Clinical conduct, Bioanalytical studies, PharmacoKinetic studies, and Statistics, report preparation, were fast tracked, adhering to all regulatory guidelines and focus on quality. The entire study was completed within 90 days.

What is the reason behind Navitas Life Sciences’ good record with FDA inspections?

Quality has always been our Priority No.1, and this is in the DNA of our organization. In our tenure of more than 15 years, we have faced several USFDA and other regulatory audits and have completed them successfully, and at times, our systems and process were even appreciated by the inspectors.

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 the 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.

IDMP

What does it mean to get an FDA clearance for a drug that you helped support?

This was a rescue study for the sponsor wherein they needed to submit the study to FDA within the stipulated time to retain the marketing continuity, and we were aligned to support the sponsor to the best of our efforts to overcome it successfully.

Meet Dr. Ayaaz Hussain Khan at CPHI 2022

Navitas Life Sciences is excited to be exhibiting at CPHI

CPHI Frankfurt 2022

Date: 01 – 03 November

Booth: 91H74

Find out 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 by scheduling a meeting with Dr. Ayaaz Khan

To know 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.