Marketing a drug in France, what are the responsibilities of an exploitant?
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The Quality Management System (QMS) is the backbone of every life sciences organisation. It is the formalized system that documents procedures, processes and responsibilities for achieving regulatory and quality policies and objectives.
A well designed, tailored and implemented QMS should enable and facilitate your organisation to effectively and efficiently progress through R&D, Clinical and Commercial operations. A one-size-fits-all approach is neither practical nor preferable. Instead, the QMS should be phase-appropriate. It should be fitted and adapted to the organisation’s development stage – whether you’re in early clinical, late clinical or commercial – and to your business model, for example: in-house manufacture versus virtual or contract manufacture.
PharmaLex’s global team of consultants, which includes a number of former US FDA and EU Inspectors, are experts in developing, tailoring and implementing robust phase-appropriate Quality Management Systems to meet these requirements for quality and compliance across the Product Lifecycle.
Before QMS development starts, it is critically important to understand the organization in which the QMS will be implemented. This will determine how the core requirements will be developed, as well as identifying additional requirements to fit the organization’s specific needs. This structure can broadly be broken into the following components:
We will guide you through the QMS design process, usually in a virtual or in-person workshop. Our consultants will then prepare a QMS Design report that presents you with a QMS framework and work plan for the development of the QMS. Where there is QMS documentation already available our philosophy is to leverage what’s available, update it where needed and develop new documents to fill the gaps.
Whether it’s a resource, expertise or time constraint, PharmaLex is always ready and available to support your QMS development or QMS update. We can provide all development activities in full, including development / update of: the Quality Manual / Site Master File, Standard Operating Procedures (SOPs), Forms, Quality Agreements, Training Material or Work Instructions.
We work in close association with your QA team throughout the development phase and we can flex up or down as your team needs more or less support.
If your organization is at an inflection point and requires an Electronic QMS your first step should be a conversation with PharmaLex. Whether you are a looking to change a large enterprise systems or implement your first e-QMS in an SME organization we offer expert advice to ensure that your shortlisted options are the best fit for your organization.
We have experience with many systems of all calibers. We have carefully selected and partnered with the leading system providers and have an in-depth understanding of the strengths of each platform. This detailed knowledge means we are ideally placed to support the deployment, configuration, validation and use of these systems in your organization.
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There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.
Large Pharma, Global
VP Regulatory Strategy
VP Regulatory Strategy
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Thomas Dobmeyer, CEO PharmaLex
CEO PharmaLex
CEO PharmaLex