Our experienced compliance consultants will seamlessly integrate with your team to go beyond imply identifying potential risks. We provide recommendations to mitigate those risks and will work side-by-side with you to implement improvement plans and collaborate with your team to finding and executing solutions.
Inspection Readiness and GxP Audits
Any firm that outsources regulated activities such as clinical studies, manufacturing of pharmaceutical products or medical devices, production of raw materials, or laboratory services requires routine qualification audits.
Companies are expected to be compliant and continuously improving. As your partner, we maintain alignment with new, existing, and changing regulations and industry standards that evolve throughout the drug product and device lifecycle. Our auditors have real world experience supporting regulatory inspections and preparing companies for pre-approval inspections.
Our team of specialists includes former regulatory agency inspectors and qualified auditors who are proficient in conducting mock inspections, internal audits, vendor and supplier auditing, and gap assessments. We serve as an extension of our client’s Quality Department with respect to vendor and supplier auditing or act as a mock regulatory agency representative with respect to preparing your organization for an agency inspection. Partnering in a constructive and collaborative manner, we work together to understand, identify, and evaluate systems for quality improvements.
With offices and quality and compliance consultants located all over the world, ProPharma offers the availability to execute audits in different GxP areas on a global basis with diverse language skills, creating efficiencies in both time and money. Our large team of qualified auditors have a breadth of expertise across the entire development and regulatory spectrum (GMP, GCP, GLP, GCLP, GPV, ISO-13485, CSV, Data Integrity, etc.).
Quality Investigations and CAPA Support
A key component of any modern quality system is the risk-based response to observed manufacturing, testing, and distribution discrepancies, or as the result of product complaints. Good Manufacturing Practice (GMP) regulations and industry guidance all describe the criticality of implementing a structured approach to performing investigations with the intent of determining root cause of the discrepant issue. Determining the root cause is necessary to implement specific and effective corrective and preventative action (CAPA) to remediate and prevent reoccurrence of the issue, and consequently facilitate continuous improvement.
For over 20 years our experts have delivered thousands of investigation reports with teams ranging in size from a single investigator up to teams of 45+. Our project success follows a thorough project initiation procedure that dictates everything from onboarding to resource loading through execution of deliverables and metrics reporting. Our diverse and experienced SMEs are another key to our success. The lifecycle of discrepancy and complaint management can be quite complex and often requires input from multiple subject experts. ProPharma has all the experts needed to support your program. Our team will integrate with yours and provide investigation and CAPA support within your quality system, or we will help to develop and optimize your program. Our team has a wealth of knowledge accumulated through many years of industry support in consulting roles as well as operating company management defending investigation and CAPA systems to regulatory bodies.
When you partner with ProPharma, you gain the experience of the entire company—not just the team assigned to your project. This breadth and depth of knowledge enables ProPharma to provide you with the support and guidance you need when you need it.
EU and UK Batch Release through the ProPharma MIA License
Navigating both the specific country and general European regulations and requirements to supply medicinal products to the European markets can be a complex challenge. This applies both to Marketing Authorisation Holders (MAH) of approved medicinal products and sponsors of clinical trials.
On top of the varying requirements, MAH/Sponsors looking to enter the European markets must create tailored supply strategies per country and establish a legal entity with a Manufacturing and Importation Authorisation (MIA) and a named Qualified Person (QP) in the region.
All of which can be extremely difficult for even the most experienced individuals. The QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing or clinical trial authorisation (MA/CTA) and with GMP.
Partnering with the leading industry compliance experts will help unravel these complexities to improve business efficiency, shorten timelines, and reduce overall costs. This will allow you to further focus on product development, clinical studies, and commercialization to support patient access and safety.
ProPharma hold both EU and UK MIAs which allows us to help clients overcome the complexities of accessing the EU and UK markets, like navigating country and EU regulations and creating tailored strategies per country. It also negates the need for MAH/Sponsors to obtain its own MIA license with a QP in the region. All of which helps ensure products are released to patients in need across the EU and UK in a quick and flexible way. Especially if speed to market is an issue since obtaining an own MIA license is a much longer process (>1 year) compared to listing your medicinal products on ProPharma's license (3-4 months).
ProPharma can perform QP Batch Certification services under its own MIA licenses for pharmaceutical and biotech clients launching products to the European and UK markets, as well as release for export from the EU (e.g., to the United States). This applies to both new and existing products. Listing your products on the ProPharma MIA licenses gives you access to skilled and experienced QP's for multiple types of products/formulations including biologics, ATMPs, vaccines and small molecules.Learn more about ProPharma's MIA License →
Qualified Person (QP), Responsible Person/Responsible Person Import (RP/RPi)
Every organization in the life sciences industry is required to have a current and compliant quality system to ensure the safety and quality of all products and services. Quality assurance entails the maintenance of a desired level of quality in your products during every stage of the process, from production to delivery.
At ProPharma, our quality assurance professionals augment your internal capabilities to ensure products are consistent and safe. Our team acts as an extension of your Quality Unit, utilizing a hands-on and risk-based approach to quickly improve quality and compliance, and implement practical solutions for your organization.
Companies that intend to manufacture or import medicinal products in the EU and UK require an MIA license and a designated named QP to oversee the product quality throughout the supply chain. Acting as an extension of your organization, our QP consultants bring a deep understanding of GMP processes. They work with your team to ensure compliant manufacturing and/or importation of products in the EU and UK markets. Our global team of certified QPs have broad experience covering multiple types of formulations, complex supply chains, technical transfer projects, aseptic/sterile manufacturing, radiopharmaceuticals, biologics, ATMPs and supply for clinical trials.
To procure, sell and distribute medicinal products in the EU/UK markets you need a Wholesaler Dealer Authorization (WDA) and a Responsible Person (RP) named on the license. A WDA in the UK can also be used to import QP-certified medicinal products from the EU. In that case you would need a Responsible Person (import). The RP has the quality oversight of the company's wholesale operation and has the main responsibility to assure compliance with GDP regulations and that the quality of the products distributed is maintained.
Our highly experienced RPs can act as contractors named on your, or a third party's, WDA for both human and veterinary medicines under EU and UK Guidelines. If you are new to the EU/UK market we can help you navigate the road from QMS build, through the WDA application process, a successful inspection and obtaining your very own WDA license.
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