Generics
Development
Be First-to-Market with our Bioavailability &
Bioequivalence (BABE) CRO Services
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
Immediate release
Modified release
Modified release
Complex generics
Patient based bioequivalence studies
Clinical endpoint bioequivalence studies
Clinical endpoint bioequivalence studies
Special studies
Euglycemic clamp studies
Inhalation 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 13 LCMS and 2 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
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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.
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
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 450+ 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
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).