20 Jan 2024

Reply

Looking for a GMP certified CDMO for Tech Transfer of Liquid and Semi-Solid FDFs [ENA18932]
A CMO that focuses on manufacturing, licensing & marketing of various OTC & Rx finished formulations is looking for a GMP certified CDMO for Tech Transfer of Solid, Liquid and Semi-Solid finished formulations. The projected annual manufacturing volume is 30 MT – 1000 MT. The country of distribution is Europe & United Kingdom and the geographical preference for service provider is Europe.

Comments :

sales1@vivindrugs.com

We have CMO facility with EUGMP, Korean GMP, UKMHRA, Russian GMP, COFEPRIS, TGA, WHOGMP & many other approvals. Our manufacturing facility located in Hyderabad, India

16:39,  20 Jan 2024

service5@dragonpharm.com.cn

Hangzhou Dragonpharm can supply such service.

08:29,  22 Jan 2024

Cristonelifecare@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

18:59,  22 Jan 2024

Cristonelifecare@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

17:16,  23 Jan 2024

bd@stabicon.com

We can help you with your requirements. Please write back to connect.

12:08,  21 Feb 2024

bd@stabicon.com

We can support with your requirements.
Kindly reach at bd@stabicon.com

18:12,  23 Feb 2024
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