03 Oct 2023

Reply

Ivacaftor API needed in India [ENA18204]
A company that focuses on the research and development of OSDs, oral liquids, injectables, ointments & creams is looking for suppliers of Ivacaftor API for development purposes. The suppliers must support this enquiry with CoA.

Comments :

hostrinlifesciences@gmail.com

Dear Friend,

Greetings from Hostrin Life Sciences!!!

Hostrin offers the following services:

1.We do support Tech transfer and Dossiers for Pharmaceutical, Biopharmaceutical, Nutraceutical, Biotech and Biosimilars in CTD, eCTD, ACTD, ANDA formats. DMF support for API's as well.

Tech transfer support and Registration of Dossiers in MOH /MHRA/EMEA/FDA with 5 modules including BA and BE studies /Clinical studies/trials for finished formulation's in Pharmaceutical, ayurveda, Biotech, Biosimilar, vitamins , Peptides and Transdermal patches too.

2. eCTD publishing with potential softwares like Lorenz/Docubridge/PharmaReady/E-Way addressing post submission queries from all regulatory authorities.

3. Support for Impurity's, Reference standards and RLD's

4. Services for IPR & Regulatory compliance with all risk assessments.

5. Services for Quality Management Systems: GXP/GMP Advisory & EU-GMP/UK-MHRA/TGA/PMDA/WHO-GMP/PICS and USFDA_21_CFR with all GAP filling Audits.

6.Supporting for QBD - SIGMA TECH Software version 3.1 for DOE, Robustness for the R&D in Pharma, Biotech, Biosimilars manufacturers to save the time and cost effective technology.

7. Custom synthesis, contract manufacturing services and conducting BE studies and clinical studies from US-FDA,EU-GMP, UK-MHRA, TGA-Australia approved CRO's/BE Study Centers.

8. Synthetic Resin technologies support.

9. Cleaning validation/ toxicology studies reports (PDE/ADE I OEL) values for commercial manufacturing of APIs and finished formulations.

10. Pharmacovigilance services.

Pls don't hesitate to send your inquiries. For your reference, please go through our website www.hostringlobal.com

For all supply related queries like API, Intermediates, Finished Formulations please visit our website www.cristoneglobal.com

Best Regards,
Andrew P
CEO & Managing Director
Hostrin Life sciences
hostrinlifesciences@gmail.com
andrew@hostringlobal.com
Mobile/
WhatsApp: +91 9949930343
www.hostringlobal.com

12:18,  03 Oct 2023
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