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| Regulatory |
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Regulatory Compliance |
In the days gone by it was enough to just manufacture the drug and test the end product to prove the quality of the product. The next stage in the evolution of quality standards involved evaluation, improving and optimizing each and every input and process involved in the manufacturing of the drug so as to have the best output.
At Neiss Labs we are constantly improving our quality standards in all areas and we understand the need to anticipate and be prepared for stricter Regulatory requirements in the countries that we are exporting to as well as in our home country. |
| At Neiss Labs the regulatory Department works closely with the Production and Quality departments to ensure that the high standards being followed are captured in documentation as we understand that from the Point of view of the Regulatory Agencies WHAT IS NOT DOCUMENTED, HAS NOT BEEN DONE
Our manufacturing plants are WHO-GMP compliant. The manufacturing facilities are in compliance with major regulatory bodies around the world including MCA, TGA and MCC |
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Regulatory Support & Services |
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Besides documents such as raw material, finished product and packaging specifications, method of analysis, certificate of analysis , validation of method of analysis, validation of manufacturing process, in-process controls etc, we can also provide Clinical Trials, FDA certificates and BE studies for registration of our products as per guidelines of health authorities in most countries. |
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OUR REGULATORY DEPARTMENT IS ADEPT AT PROVIDING COMPLETE DOCUMENTATION SUPPORT IN THE FORM OF REGULATORY DOSSIERS FOR SUBMISSION TO HEALTH AUTHORITIES. |
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