What We Do

Acesst Pharmatech provides services in Quality Assurance and cGMP for Pharma and Medical Devices

All the Regulated industries/companies are compliant same as their vendors/suppliers any noncompliance with regulations at the vendor/supplier are liabilities of the company. Company is held responsible for its vendor/supplier qualification and its oversight.

With increasing globalization of operations, vendors/supplier for all aspects of development are involved at all geographic locations. Most discussions for foreign vendor/supplier qualification are limited to manufacturing operations while clinical trials, centralized labs, and animal testing facilities have an almost equal probability of being located at a foreign site. It works both ways, company using bad vendors suffer the financial, regulatory and legal consequences, while for vendors with bad history, it is hard to find new business. Hence, just like the regulated company, vendors also need to assure that the client is suitable and will not cause major issues later.

Secondly, If your company is marketing a product or service that is regulated by the FDA, you should be prepared for an FDA audit. If you have never been audited by the FDA you need to prepare for the same or if you were last audited 4-6 years ago, if any product you supplied has been in the news – positive or negative, or if you are getting ready to submit a marketing approval application, chances are you would get audited by the FDA in the near future. Although different facilities are subject to different regulations, FDA auditors follow some general guidelines that are common across all.