Calculation of PDE/OEL and Risk assessment reports of impurities
Product Description
Indivirtus Healthcare Services Pvt Ltd
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IN -
2021On CPHI since
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2Certificates
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25 - 49Employees
Company types
Primary activities
Categories
Specifications
Indivirtus Healthcare Services Pvt Ltd
-
IN
-
2021On CPHI since
-
2Certificates
-
25 - 49Employees
Company types
Primary activities
More Products from Indivirtus Healthcare Services Pvt Ltd (4)
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Product Green field, CSV and Calibration
Erection of new manufacturing facility
Expansion of current facility
PLC, SCADA and SAP validation
Calibration -
Product Pharmacovigilance and Clinical Trials-Phase III & Phase IV
Pharmacovigilance activities are performed by using the database with integrated gateways for case submission to all regulatory agencies. We perform ICSR processing, aggregate reporting and Signal detection activities
Team has Experience of performing 90+ Phase III and 110 + Phase IV trials for ... -
Product Regulatory Writing
Regulatory team is headed by experienced professional with 15 years of experience working with all regulated and RoW markets -
Product Technology transfer and Plant approvals from EU GMP/USFDA/PICS/EA EU etc.
Technology Transfer-Experienced team of scientist visit the plant for preparation and training of manufacturing team to manufacture prototype and exhibit batches, analytical testing and stability studies
Plant Approvals-Experienced auditors and QPs perform the gap assessment and help the manufac...
Indivirtus Healthcare Services Pvt Ltd resources (1)
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News Featured in Forbes, Fortune, Entrepreneur First, Innovative Zone, Prime Insights and Swift & Lift
- Recognized as “Raising the bar of healthcare with personal touch” by
Fortune India
- Recognized as service provider with “Promising Quality Improving Economy” by Forbes
- Recognized as "Company in Focus 2022" by Innovative Zone Magazine
- Recognized as “Top 10 Innovative CEO’s to watch in 2022” by Entrepreneur First
- Recognized as “A Cost Effective Healthcare Service Provider” by Prime Insights
- Rated as “Top 10 Clinical Trials Service Provider” by Swift & Lift
Frequently Viewed Together
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Product Biologic drug substance CDMO services
From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
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Product Cell bank and virus seed characterization
As a world leader in biopharmaceutical testing services, we offer you a comprehensive range of biologics safety testing , including virology, cell and molecular biology, as well as microbiology and electron microscopy. As a result, we can help you to ensure product safety and meet your regulatory requireme...
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Product HPAPI Sterile Dispensing Isolator
Single chamber barrier isolator configured in order to grantthe dispensing procedure for API product achieving the followingtasks:• Assure a sterile environment inside the isolator. Assure operator protection, when the processedproducts are highly active.The barrier isolator operates under a positive ...
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Product OEL/ADE/PDE Reports
Affygility Solutions has an extensive database of over 2,300 monographs.
Our OEL/ADE/PDE monographs prepared and endorsed by our in-house DABT/ERT certified toxicologists. This guarantees compliance with regulatory authorities such as EMA, PIC/S, ANVISA, and WHO.
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Product Viral Vector Characterisation and Release Testing
Viral vector characterization and release testing services from Intertek's centre of Excellence for Biologics Characterisation, help you to establish and address critical quality attributes (CQAs) that impact product safety, purity, and potency. We deliver robust analytical assays to assess vector pro...
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Product Sterile/Toxic Isolator
Containment systems for sterile applications may be proposed in the form of closed isolators or Restricted Access Barrier Systems (RABS).
A sterile isolator allows to avoid the use of sterile cleanrooms, reducing the sterile volume around the process being executed.
Turbulent or unidirectional fl...
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Product Safety and Toxicity
- In vitro testing for skin corrosion (OCDE TG341);- In vitro testing for skin irritation (OCDE TG439 and ISO 10993-23:2021);
- In vitro testing for eye irritation – HET CAM (ICCVAM)In vitro testing for vaginal irritation (SOP Mattec Epivaginal);
- In vitro testing for Permeation studies of compounds...
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Product Permitted Daily Exposure monographs (" PDE ")
More than 1,000 API substances PDEs have already been developed in house.
New monographs are being developed on a constant basis.
Any PDE monograph can be developed upon request.
Our rates for PDE monographs are based on several factors such as status of development of the monogra...
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