Overview
Are you compliant? This is a question which any Pharmaceutical, Biotechnology, Genomics, Chemical, Medical Device and Supply Chain Management company find challenging to answer. It is mandatory for these organizations to comply with stringent quality, safety, and Regulatory requirements in each geography where the products are distributed. The current trend is moving towards a worldwide harmonization of quality and safety. Whether you are a manufacturer or a supplier, your business expansion, continual improvements and customer satisfaction rests principally on the quality standards of your business. Freyr’s Compliance and Validation Center of Excellence (CoE) can help in this effort by assisting you with professionally aided compliance audit services for pharmaceuticals, medical devices, consumer healthcare industries such as: cGMP (Current Good Manufacturing Practices), GCP (Good Clinical Practice), GDP (Good Distribution Practice), Good Laboratory Practice (GLP), GPVP (Good Pharmacovigilance Practice) and your GxP Computer System Validation (CSV).
Freyr provides Regulatory compliance services that involve evaluating your requirement and suggesting inputs to the business processes that are designed to assure customer satisfaction as well as compliance. With our audit preparation and readiness strategies, we provide audit (gap analysis) report along with suggested actions for corrective and preventive actions (CAPA) to avoid potential 483s and audit findings from regulators.
With uniquely designed in-house and on-demand compliance best practices and Regulatory compliance management, Freyr ensures that all your processes and products are aligned with applicable quality, information security, compliance and Regulatory requirements such as (but need not be limited to) the following.

Freyr performs around 700 checks at a preliminary level spread across 18-19 GMP functional areas
We ensure that all your processes and products are aligned with applicable quality, information security, compliance and Regulatory requirements such as (but need not be limited to) the following.