At PCI, ensuring life-changing medicines reach those who need it most is our highest priority. As a truly integrated global CDMO, we are manufacturing, packaging and supply chain experts, harnessing our experience and expertise to deliver you a seamless solution with the ultimate aim of improving the lives of patients.
PCI Quality and Regulatory Services (QRS) offers our customers bespoke services to assist with quality and regulatory solutions throughout the drug product lifecycle.
The PCI-QRS team draws on a pool of expertise within the PCI organization and a trusted network of external consultants to provide solutions to ensure your drug product is delivered to patients with the highest levels of quality, safety, and regulatory compliance.
Our industry leading experts are able to provide quality and regulatory expertise, supporting you through your clinical program through to commercial marketing authorizations.
The services provided can be tailored to your individual needs and include the following:
Quality audit services – PCI-QRS will provide a centralized audit service, giving you an enhanced customer experience. The assigned team member will collaborate with you in the preparation, execution, and remediation to ensure key touch points are covered during the audit process
CMC consultancy and writing – a bespoke service that can be utilized at the level of support you require from full dossier writing to individual sub sections or independent review of CMC documents compiled by third parties
Regulatory support – supporting you from a CMC perspective at scientific advice meetings and end of phase meetings
PSF fast track readiness – let us help to align your documentation so that you are ready to launch your EU clinical trial as quickly as possible
Commercial readiness – a support service delivering local market expertise and assistance with commercial registration to complement your in-house capabilities
Standalone quality services:
Person in plant – assessment of quality/ compliance issues
Deviation investigation support
Quality Technical Agreement support
QMS development
Regulatory inspection readiness
The services offered by PCI-QRS can be customized to meet your needs. At the outset and as a potential virtual company, you may choose to utilize PCI-QRS to support your core staff and as the relationship grows we can adapt to meet your needs and ensure that we share the knowledge we have attained with your growing team.
PCI-QRS will assess your needs and assign one of our pool of experts most closely aligned with the skills and experience you need. Working with the PCI-QRS team we will create a detailed RACI matrix to agree roles and responsibilities and agreed levels of collaboration which are required to support your needs.
Our highly experienced PCI-QRS team is also able to guide the establishment of processes and SOPs when they do not exist or are not robust.
The team is able to create process flows and author SOPs to fit within your quality system on any quality or regulatory aspect such as:
Vendor management
Deviation management
Change control
Lot release
Validation
Customer complaints
Recall and recovery
The PCI-QRS team will integrate with your internal
team, bridging the gap and aligning objectives.
A truly turnkey solution that can be utilized to meet your needs
Your PCI-QRS support will become true subject matter experts in terms of your product, program, objectives, and key regulatory milestones
Deliver local market intelligence and a gap analysis to identify potential challenges ahead of the regulators
Access to a pool of expertise that is matched to your specific needs
