A closer look at the USFDA Review of Our Generics Studies

A report by globalnewswire highlights the growing market for generics, with the generic drugs market in 2020 valued at US$ 390.57 billion expected to cross US$ 574.63 billion by 2030, at 5.59% CAGR from 2021 to 2030. The ever-growing pharmaceutical industry and innovations in the drug development process necessitate competency to carry out a wide variety of studies.

Navitas Life Sciences has proven expertise in a wide variety of studies which include 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 and many more. We understand the strategic importance of delivering high quality studies which is why we have an impressive record with the FDA


BABE Studies Conducted


Bioanalytical Methods Developed


Marketing Authorizations

Remote record review by USFDA

The U.S Food and Drug Administration (FDA) conducted a remote review of our Generics Business Unit’s Bioequivalence Studies,

  • with 4 inspectors from their US office (Office of study integrity and surveillance, Division of Generic Drug Study Integrity)
  • across 4 days

Covering the study data, systems, processes and controls

Navitas Life Sciences fully and successfully supported the seamless conduct of the review with prompt data provision, that culminated in a successful closeout, “without any observations for discussion”

In this blog, Navitas Life Sciences caught up with Dr. Raghavendra Shetty, Assistant Vice President - Bio-analytical, Navitas Life Sciences, Dr. Aruna Theerthahalli, Head – Compliance and Scientific Affairs, Navitas Life Sciences and Manju Thomas, Head-QA department, BA/BE, Navitas Life Sciences to illuminate the efforts taken to stay compliant. Here is an edited version of their conversation.

Give us a snapshot of your professional background

I completed my Postgraduate in Pharmaceutical Quality Assurance and Doctorate in Pharmaceutical Science. I have overall experience of 17+ years in the field of bioanalytical research. I joined clinical research at Navitas Life Sciences and have been involved deeply in setting up the bioanalytical lab, systems, and processes. My Core strength is in developing novel methods for bioanalysis, and I was involved and mentored developing more than 300 methods and have supported more than 1000 BABE studies till date at Navitas Life Sciences. I have also been a part of various regulatory inspections both national and global agencies, which include CDSCO, USFDA, EMA, WHO and NPRA inspection multiple times.

What was your role in the remote review by US-FDA?

I had a major role in this remote review as this was specific to Bioanalytical and I was the Study Director for all the studies selected by the USFDA inspectors for remote record review. This was the first time at Navitas Life Sciences that we were facing the remote review by a global regulatory body and this was very exciting as well.

Dr. Raghavendra Shetty

Assistant Vice President -

Navitas Life Sciences

We could successfully address all clarifications and concerns discussed and raised by the inspectors on the studies as well as systems and processes. The virtual facility tour was conducted flawlessly, thanks to the recommendation by the leadership and teams.

We would like to thank our IT-Infra team that helped us with seamless connectivity, required IT support & timely query resolution which were the key elements of success of this remote review. Of course, it is immense dedication and sheer hard work of the bioanalytical staff involved in those studies with high level of integrity that enabled the successful remote review.

What is the significance of the US-FDA review that was conducted recently?

The inspectors intently reviewed the data of three projects and the validation of two molecules during the remote record review that lasted for a week. The outcome of this inspection was very successful, with the closing remark being no objectionable findings.

How many reviews have you participated in?

I have participated in more than 20 regulatory inspections since the inception of this organization by representing the bioanalytical department. To date, all the inspections have been very successful, without any major findings.

What are the additional tasks that were carried out to prepare for the review?

When compared with routine in-person inspection, the additional tasks in this remote record review process were

  • Creation of a robust IT infra for seamless data review and to conduct a virtual tour
  • Access to sufficient electronic data for review with all required software installed for demonstration of data
  • Multiple rehearsals and mock runs to seamlessly support the virtual tour and reduce lag time in document provision. This allowed timely provision of requested documents, which is an important attribute for a successful regulatory inspection or review.

How many days did you have to prepare for the review?

We had one week for remote record review upon submission of requested documents.

Tell us about your professional background?

I am a doctorate in Pharmaceutical Sciences and I have around 17+ years of professional experience in the pharmaceutical domain. I am the Head-Compliance and Scientific Affairs department in Generics Business Unit of NLS, overseeing quality control, compliance activities and supporting regulatory and external query resolution and scientific content writing.

What was your role in the remote review by US-FDA?

I was part of the team led by Dr. Shetty, assigned as the point of contact to coordinate and enable the provision of organizational, system, and study data to the USFDA review team. This included Remote data provision a priori and support for remote live review.

As a part of data provision, I needed to work closely with the leadership to generate writeups and work with

Dr. Aruna Theerthahalli

Head – Compliance and Scientific Affairs

Navitas Life Sciences

internal departments to develop study listings, de-archival of master files. I was also involved in coordination between the bioanalytical team and the IT team to ensure sufficient IT infrastructure to scan and upload information in a structured and sequential manner, as per the USFDA's recommendations and expectations for remote review, before the actual live remote review.

What are the steps taken to be audit ready?

Data, and data integrity, are at the core of any successful regulatory inspection. At Navitas Life Sciences, we do it the right the first time, which for us, is the only and best approach to be inspection ready.

At Navitas life Sciences, we place the highest emphasis and oversight during the study conduct and confirm oversight, accountability, and ownership at every stage of data generation. This conforms with ALCOAC verification and with Good Clinical Practices.

Staying Inspection Ready

  • Strict adherence to Regulatory requirements
  • Robust Quality Management System based on ISO 9001:2015
  • Scientifically structured Standard Operating Procedures
  • Execution of necessary checks
  • Well-defined Quality Control
  • Strong quality focused leadership

We ensure that we are inspection-ready at the time of project completion, with oversight at GL level, in processes QC and Study Director Oversight, along with independent QA audits during, and post-study. This approach helps us stay ready for inspection, whether it is announced or unannounced.

What is the difference between in person review and remote review?

This was a very first remote review opportunity we had, enabled by USFDA. This was a unique and an exciting opportunity for us, and a great learning experience. With seamless support and connectivity helped by NLS IT team, it is not an exaggeration to say that the review was quite close to the real-time inspection experience.

How did you prepare your team to be inspection ready?

There was no specific preparation needed as the inspections and audits are not uncommon, However, we do sensitize the team once we receive intimation on the inspections/audits. We closely support and work with the team constituted for seamless execution of the inspection. In this case, we strategically positioned ourselves and worked closely with the core team to support the inspection process and provisioned necessary coordination to the QA team.

Tell us about your professional background?

I have completed my Postgraduation in Instrumentation and Commercial methods of Industrial Analysis and I have an overall experience of 19+ years in the field of Clinical Research. I have taken up various roles during this period, which includes QMS implementation, audits of BA/BE studies & Clinical trials, hosting regulatory inspections and client audits, regulatory query resolution and CAPA implementation.

Currently I head the QA department for all the BA/BE facilities of NLS. Team comprises of highly qualified auditors who support the entire QMS function and audits.

What was your role in the remote review by US-FDA?

As this was a remote inspection by the agency, we were requested to upload the study documents in the USFDA

Ms. Manju Thomas

AGM Quality Assurance

Navitas Life Sciences

portal. Under my guidance, my team executed the data review for completeness and appropriateness before uploading documents to the portal. A list was prepared for the anticipated documents required during the inspection, also all the facility records were scanned and kept ready to ensure that any request from USFDA is fulfilled immediately.

During this inspection, I was available throughout to ensure the smooth conduct of the inspection by coordinating with cross-functional departments.

Who conducted the remote review by the US-FDA?

It is was a team of four inspectors from the USFDA’s US office (office of study integrity and surveillance, Division of Generic Drug study Integrity) who inspected the study data.

What aspects did this remote review cover?

We successfully completed 4 days remote review by USFDA. 3 studies inspected over a period of four days which includes study data, systems, processes, and controls. We were able to answer their queries efficiently and provided all requested documents on time. There was no observation for discussion.

How did our sponsors respond to the outcomes of the remote review by US-FDA?

Our project management team shared the outcome with sponsors and received positive feedback

Thank you for sharing this great news with us. Congratulation Navitas Life Sciences team for the successful FDA Audit.
– Global leader in Generic Pharmaceuticals.

Congratulations for successful USFDA audit with no objectional conditions.
– Leading Global Generic Pharmaceutical company.

Congrats and great to hear about the USFDA inspection without any findings.
– Leading Malaysian Pharmaceutical Consultant.

Congratulations! It’s good news and we also got the clearance for another Bio study conducted at your facility from Bioequivalence Discipline Review division.
– US based fastest Growing Pharmaceutical company.

Congratulations to you and entire Navitas Life Sciences team on successful completion of Remote record review by USFDA with no objectionable condition.
– Leading Indian Generic Pharmaceuticals.

Congratulations for the good news! Even though we never had a doubt, it is very encouraging and comforting to know that we have a clinical partner that upholds such high standards.
– US based Specialty pharmaceutical company.

Congratulations Team Navitas Life Sciences !!
– Canadian Generic Pharmaceutical company.

Congratulation to your team...
– Bangladesh based Leading Pharmaceutical company.

Congratulations Team...
– Leading Canadian Pharmaceutical company.

The Generics drug development industry is a dynamic industry that has a deep impact on the health system. The use of innovative methods and rapidly evolving technologies will aid in bringing the drugs to the market sooner, with adherence to regulations forming the central plank to staying competitive. The “no observations for discussion” from the USFDA post the recent review of our BABE team is a critical factor for multiple re-engagements with top pharmas from the world.

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