Generics
Development

Be First-to-Market with our Bioavailability &
Bioequivalence (BABE) CRO Services

We support all your generic drug development needs

Bioavailability (BA) and Bioequivalence (BE) studies are carried out for developing a new formulation or for marketing a generic drug. In order to market a generic drug, BABE studies are required for approval from health authorities like US FDA.  The drug that is being tested is studied against a well- known and commercially available drug, at same concentrations and under conditions that are similar. Companies file their Abbreviated New Drug Application (ANDA) according to 505 (j) or 505b (2) to the US FDA for marketing authorization in USA. Selection of the right clinical research organization is vital for a successful market launch.
With over 90% of the prescriptions in the US market being fulfilled by generics companies, the competition in this space is growing exponentially. This makes it imperative for generics companies to be first-to-market, while adhering to stringent regulatory requirements, ensuring high quality outputs, and maintaining a cost advantage. Navitas Life Sciences is the leading clinical research organization (CRO) with over 100+ marketing authorizations obtained through bioavailability and bioequivalence (BABE) studies. Our capabilities include

Generics Drug Development

Generics

Generics

Immediate release
Modified release
Complex generics

Complex generics

Patient based bioequivalence studies
Clinical endpoint bioequivalence studies
Special studies

Special studies

Euglycemic clamp studies
Inhalation studies

Bring Your Generic Product to Market
Quickly & Effectively with Our End-to-End Services

Study Design


Design & plan your study with our experts to ensure successful outcomes

Study Conduct


Your BABE Studies are conducted seamlessly, in state-of-the-art facilities with strict regulatory compliance

Bioanalysis


Barcoded samples are processed across 2 21-CFR-Part-11, GLP Compliant laboratories equipped with 12 LCMS and 1 ICPMS

Data Standardization & Analysis


Expert biostatisticians are available to standardize and analyze your study data

Dossier Preparation


Quickly prepare your ANDA dossier for filing with our strong expertise in regulatory affairs

Regulatory Submissions


Our regulatory submissions services are backed by a cutting-edge technology platform that enables first-time-right submissions for 505(j) an 505(b)(2) submissions

Pharmacovigilance


Bring patient safety to the forefront with our expert pharmacovigilance services and systems
Complex Generics
Complex generics are generic products with a complex active ingredient, complex route of delivery or even a complex formulation. Conducting BABE studies for complex generics requires specialized expertise over that required for simple generics. There is a need for better planning, quality and regulatory assessment, in order to bring complex generics drugs to market. At Navitas Life Sciences, we adapt our studies to address these challenges and to ensure first to market strategy, for exclusivity and for better patient benefit. We have supported multiple companies in filing for both 505 (j) or 505b (2) pathways as required by US FDA for marketing authorization.
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Proven Expertise
The ever-growing pharmaceutical industry and innovations in drug development necessitate competency to carry out a wide variety of studies. Navitas Life Sciences have 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
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BABE Studies Conducted
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Bioanalytical Methods Developed
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Experts (including Doctors & PhDs)
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Marketing Authorizations

Learn more about how we can help your Generic Product get to market

Get Yourself The Navitas Edge

Extensive Expertise

With over 50 experts in Generics, we have conducted more than 1000 Bioequivalence studies with over 100 marketing authorizations. Whatever your approval pathway, our team has expertise with supporting successful 505(j) and 505(b)(2) studies as well. Our experts have developed over 260 validated bioanalytical methods, and can develop validated methods within 4 weeks.

Comprehensive Capabilities

We have capabilities in conducting simple generics, complex generics (including patient-based BE studies, and clinical end-point BE studies), as well as specialized studies (euglycemic clamp studies, and inhalation studies). We also have the capabilities to support your clinical data standardization & analysis, regulatory submissions management, and pharmacovigilance needs.

Infrastructure Investments

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.

Assured Compliance

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.

Audit Record

We have had 20 successful inspections over the last 10 years by 5 global regulators including USFDA, DCGI, ThaiFDA, EMA (ANSM & AGES), and WHO.

Volunteers Database

We have 25000+ volunteers in our database including 1000+ female volunteers with 700+ post-menopausal women. Our patient cohort includes oncology, renal, diabetic and hypertensive patients.

Confident Clients

No wonder top 30 global and top 10 Indian pharma companies trust us to bring their generic products to market.

Navitas Life Sciences brings together domain experts to cater to your bioequivalence and bioavailability study requirements

We are adept at providing cost-effective, timely, end-to-end services to meet the specific requirements of your generic product.  We cater to your needs right from study design, to conduct, to bioanalysis, to data standardization & analysis, to dossier preparation, to regulatory submissions, to pharmacovigilance.

Leverage Any of Our 280+ Validated Bioanalytical Methods For Your Study

In case we don’t have the method you need already, our Bioanalysis experts can develop a validated method for you within 4 weeks

Take your biosimilar insulin first to the market

At Navitas, we understand the complexities of biosimilar insulin and have vast experience and technical know-how, along with superlative equipment to get your drug to the market first!

Euglycemic Clamp Studies

Right Infrastructure

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Clinical Pharmacology Units
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Beds
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Volunteers
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Bioanalytical Labs
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Mass Spectrometers
Inhalation Chambers

Inhalation Chambers

State-of-the-Art Infrastructure Meets Stringent Processes To Conduct Your Inhalation Study

Our best practices include dosing in segregated chambers, videography of dosing, and much more. Our ultra-modern equipment can detect even the lowest lower limit of quantification (LLOQ).

Inhalation Studies