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Assisting Indian Pharmaceutical Firms with Regulatory GMP Inspections

July 25, 2018

Pharmaceutical firms in India have turned to SeerPharma for assistance on matters of Quality Assurance and GMP compliance.

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Implementing FDA, EMA and PIC/S GMP

September 22, 2016

SeerPharma (Singapore) was engaged by a company in Singapore to help implement cGMP for a new clinical trial packaging facility and obtain international certification of conformance to FDA, EMA and PIC/S GMP.

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FDA and TGA GMP Inspection Help for Pharmaceutical Company

June 07, 2016

An Australian pharmaceutical company engaged SeerPharma to prepare them for a TGA and FDA GMP inspection. Their Engineers were relatively inexperienced in dealing with regulatory inspections and the company required them to gain experience quickly in preparation for the FDA’s arrival. SeerPharma were requested to perform a mock audit to help...

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Developing a Supplier QA Program in Pharmaceuticals & Medical Devices

March 10, 2016

As a manufacturer or sponsor of a pharmaceutical and/or medical device, you need to ensure control over component and product quality, as well compliance with legal and customer requirements. Establishing and maintaining a supplier quality assurance program can be a challenge, with regulatory requirements and supply chain complexity continuing...

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Effective CSV in the Pharmaceutical / Medical Device Industry

February 26, 2016

You’re a Quality, IT, or Operational manager working for a Pharmaceutical / Medical Device company, responsible for the computer systems used in-house. Working in the Pharmaceutical / Medical Device industry, means that regulators such as the FDA and TGA will scrutinise the use and validation of these business critical systems.

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