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CRD TEAM

Biosimilars & Biologicals

At Veeda CR, our Biologics and Biosimilars team includes Clinical Research professional, Physicians, Medical Writers, Safety Experts, Bio analytics with extensive experience in supporting development of Biosimilars for Indian and Global Registration. The team works with a focus of developing Veeda CR as a leading service provider in the field of Biologics - both novel and Biosimilars. We understand that, this class of drug provides exceptional challenges and requires in-depth knowledge and 'out of the box' thinking, which our group is capable of.

We aim to provide services at three levels. Firstly, as a CRO we will undertake to develop your Biological drug in the clinical environment which is mandated for its acceptance in the major markets of the world. At a higher level, we would aim to advise your in-house project team on the most strategic ways forward with the molecule which you have developed. This means an intense focus on the ultimate markets for which you are aiming and the customizing of the clinical trials program to meet those markets. In a perfect world, it would be possible to have one series of trials for all markets but regulatory differences between countries means, for instance, that the reference drugs may be different. In addition to the clinical trials program from Phase I to Phase III, we offer a full set of supporting capabilities within our own services. These includes large-molecule bioanalytical services, immunogenicity analysis and pharmacovigilance both pre- and post- market authorization. Finally at the highest level we aim to interact with decision makers in companies beginning to explore the possibility of entering the biological field. Selection of the right drug for the right company is important and our experienced team can guide and support pharma and biotech companies in developing portfolios based on prior experience, capability and capacity.

Bio Similars Services

Veeda offers a full range of consulting, regulatory, laboratory and clinical development services to support biosimilar product development.

Biosimilar Studies in India
Our team of Clinical Research professional ,Physician, Medical Writers , Safety Experts with extensive experience of working in more than 20 bio similar molecule for Indian and Global Registration.
Completed projects
  • Comparative PK and PD study on GCSF, Erythropoietin, and Streptokinase.
  • Glucose Clamp studies on Insulin Aspart and Insulin Glargine.
  • Pharmacodynamics & Immunogenicity analysis for Enoxaparin.

Completed projects

  • Completed more than 10 projects for Biosimilars.
  • Comparative PK and PD study on GCSF, Erythropoietin, and Streptokinase.
  • Glucose Clamp studies on Insulin Aspart, Insulin Wosulin and Insulin Glargine.
  • Pharmacodynamics & Immunogenicity analysis for Enoxaparin.

Bio similar analytical – Experience / Capabilities

  • Completed Enoxaparin PD end point and immunogenicity studies (03 studies for USFDA, 01 study each for EU and ANVISA).
  • Pharmacodynamics endpoint Anti – Xa detection and Anti- IIa detection using Chromogenic method.
  • GAM screening assay using ELISA technique, Linearity range: 0.050 IU/mL to 0.200 IU/mL
  • Heparin Clotting assay coagulation method, Linearity range: 0.100 IU/mL to 1.00 IU/mL
  • IgG, IgA & IgM screening assay using ELISA technique.
  • PK and PD studies for Insulin where Insulin and C peptide analyzed by Elisa kits
  • GCSF using Elisa kits.
  • The ISR percentage achieved for GCSF and Insulin Aspart was found to be more than 94 %
  • Total no. sample Analyzed
    PK- 1478, PD – 3866 & Immunogenicity – 3783 samples.
Analyte No. Samples Analyzed No. of Samples Analyzed for ISR % of ISR Samples within Acceptance
G-CSF 2142 158 98.7%
Insulin Aspart 2139 158 94.9%
C- Peptide 2489 176 98.3%

Why Partner with Veeda for Biosimilars and Biologics?

  • As a full service CRO, Veeda is positioned to bring high quality services, which has been proved by our regulatory track record, with clear alignment with its client interest
  • Our in-depth understanding of complex Biosimilar clinical and regulatory process coupled with our vast experience of handling hospital sites across the country, gives us the freedom to explore localized solutions.
  • Our clinical phase incorporate the full range of services from clinical study designs, its execution to bio analytics, which include drug estimation and immunogenicity.

Our exemplary regulatory track record

USFDA
33 times
Brazil ANVISA
7 times
WHO
5 times
UK MHRA
3 times
EU - AGES
1 times
South Africa - MCC
1 times
NPRA - Malaysia
4 times
DCGI
13 times