Home > Resource Library >
Pharmacovigilance Services postcard
Place your Pharmacovigilance, and Safety surveillance activities in experienced hands. Whether you need an urgent solution for an unexpected problem or are seeking to outsource end-to-end global and local Pharmacovigilance activities – our knowledgeable experts will be there for you no matter where you are.
Posted:
DownloadCommissioning and Qualification (C&Q)
PharmaLex offers full support along the Commissioning, Qualification and Validation Lifecycle (VLC) for your new or modified facilities, equipment, and systems. Our Commissioning & Qualification (C&Q) professionals are experienced in each deliverable from the C&Q portion of the VLC; i.e. the V-Model, as established by ASTM E2500 and ISPE‘s GAMP 5.
Posted:
DownloadRegulatory Compliance - CMC Implementation
Implementing a sustainable approach to the CMC compliance process. CMC compliance is an important component in the lifecycle of a medicinal product, but is one that is continually challenged by many factors.
Posted:
DownloadHealth Economics
Early advice on health economics, reimbursement and market access strategy.
Posted:
DownloadBiosimilar Quick Links and Guidelines
Links to Biosimilar guidance by national authority
Posted:
DownloadMedical Information Services
Our extended product portfolio can serve various needs and varies from service models that help to streamline and support internal processes to successful product launch.
Posted:
DownloadPortfolio Maintenance Outsourcing
PharmaLex provides a viable Strategic Outsourcing solution, capable of maintaining your products throughout the life cycle while…
Posted:
DownloadWriting Capabilities
PharmaLex offers a number of writing services, covering technical writing, regulatory writing, medical writing and scientific writing.
Posted:
DownloadReal World Evidence
In contrast to the controlled and homogeneous setting in RCTs, the real-world setting consists of a broader and more representative patient population, where treatments are not necessarily used in accordance…
Posted:
DownloadGxP - Operate a functional and efficient QMS
A functional pharmaceutical quality system is not only a regulatory requirement, but also an integral element in pharmaceutical…
Posted:
DownloadValue Added Medicines
Value Added Medicines developments aim at enhancing well-established, off-patent molecules by optimizing their efficacy, tolerability, or ease of use or even exploring them in new indications.
Posted:
DownloadOrphan Medicine Development
Orphan medicines are intended to treat rare diseases. Both, the EU and US drug legislation have financial and regulatory incentive systems in place to…
Posted:
DownloadAdvanced Therapies - Navigating through the Regulatory Framework
The ATMP regulatory framework in the EU and the US framework programs for cell-based or gene therapy products are complex…
Posted:
DownloadBiopharmaceuticals CMC
Biopharmaceuticals are an unprecedented success story. Due to their outstanding efficacy and safety and their high potential to address unmet medical needs, biopharmaceuticals are by far the…
Posted:
Download