Quality & Compliance Support Services

Virtual Quality Assurance

MIAS provides a Virtual Quality Assurance service whereby we take control of full oversight of your supply chain and quality activities to ensure you meet all your regulatory obligations from a GMP perspective in addition to QP Release Activities.

The batch disposition process involves review of records relating to batch manufacture, packaging, analytical testing and control of transportation. MIAS Pharma has a team of Quality Assurance professionals who perform these reviews. We are set up to enable the exchange of information electronically which enables us to provide this service virtually. We engage with you as our client and with your contracted parties as appropriate to clarify and resolve any questions arising from our reviews.

Our QA service supports batch disposition:

· Of clinical and commercial products to be released under the MIAS Pharma Manufacturer’s Authorisations within the EU/EEA, and

· Of clinical and commercial products to released by our client in markets outside the EU/EEA.

Our QA service also supports post-marketing activities including:

· Support for the management of product quality complaints, quality defects and recalls.

Quality, Operations, Supply Chain and Regulatory

Quality & Compliance Support Services

Working with our client’s Quality, Operations, Supply Chain and Regulatory teams to map the physical and financial ownership flow of materials and products in your supply chain, we identify all 3rd parties involved; we evaluate their licence status; we determine if their Quality standards are adequate and we support maintenance of those Quality standards to support QP services. We provide all QP services from API declarations to routine batch disposition.

We provide integrated QP and RP services for oversight of product quality in the marketplace. We collaborate closely with our Alliance network to deliver services that need to be aligned with our QP services.