A full spectrum of pharmaceutical services.
Successful pharmaceuticals are based on solid regulatory foundations: practical approval strategies, controlled market launches and efficient quality assurance form the basis.
High efficacy, safety and quality standards must be in place for pharmaceuticals to enter the market and be sustained there in the long term. Pharmaceutical companies must make tremendous investments to meet these requirements. They’re unavoidable — but can be made as efficiently as possible.
To achieve this, approval strategies must be developed at an early stage — strategies with sound regulations that can be implemented efficiently. Companies must design systems that ensure efficient quality assurance and pharmacovigilance processes following market approval.
Diapharm supports clients in the development, manufacture and marketing of medicinal products, and in ensuring drug quality and safety throughout the entire life cycle.
Expertise that brings you closer to your goals.
Taking Responsibility
Diapharm is committed to providing Qualified Persons for Pharmacovigilance (QPPVs), Qualified Persons (QPs), and manufacturer functions, permanently or on a temporary basis. For you, this means more time for what matters most.
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Regulatory Affairs
Regulatory issues are becoming more and more complex. The path to market readiness for a product winds through a jungle of legal regulations and specific requirements. Don’t worry: Diapharm has you covered. What this means for you: regulatory strategies that are efficient and effective.
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Development & Licences
Diapharm develops new OTC drugs for the healthcare and pharmaceutical industry and takes care of licensing for existing approvals. For you, this means access to attractive products and rapid market entry.
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Investigational Medicinal Products (IMPs)
In order for new medicinal products to be approved, their safety and tolerability must be determined through clinical trials. Investigational medicinal products are used and tested during clinical trials. For you, this means a strong partner for the execution of clinical trials.
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Quality Management (GxP)
Pharmaceutical quality management, quality control, and quality assurance are the basis for the successful distribution of medicinal products. Diapharm knows the requirements and makes sure they are implemented. For you, this means quality management that’s efficient, lean, and sustainable — and that works.
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Scientific Information
Marketing medicinal products is challenging. The German Drug Advertising Act (HWG) requires distributors to ensure that packaging labels, product information, instructions for use, and advertising materials comply with legal requirements. Diapharm can master this task efficiently and reliably. For you, this means maximum security and effectiveness for all of your advertising initiatives.
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Pharmacovigilance
Drug safety is complex – setting up and operating pharmacovigilance systems, creating risk management plans and developing standard operating procedures (SOPs) require enormous resources from pharmaceutical companies. Diapharm has experience designing these systems efficiently. For you, this means relief and optimal management of your drug safety.
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”Diapharm is a key pillar of our company, making it possible for us to bring pharmaceuticals to this market.“
Dagmar Siebert
Managing Director
089PHARM GmbH
Diapharm supports companies throughout the entire life cycle of their drugs — from development to quality assurance.
Market access places high demands on efficacy, safety, and quality assurance.
Diapharm develops feasible, efficient strategies for both OTC and prescription drugs. Diapharm creates eCTD dossiers, brokers approvals, establishes pharmaceutical quality management systems, and ensures pharmacovigilance. The review and evaluation of service providers and suppliers, as well as the performance of GxP audits, is another compliance step carried out by Diapharm.
Diapharm puts the roles in place required by law: a graduated plan officer, an information officer, a wholesale officer, and a qualified person. Diapharm also acts as the marketing authorization holder for clients.
A role at Diapharm combines communication with clarity, reliability with empathy, and precision with pragmatism.
You think holistically, across disciplines, and in a results-oriented way? You’re good at analyzing, assessing and making decisions? You understand people — both clients and colleagues? You communicate with confidence — both in German and English?
Then you’ll find exactly the right role at Diapharm.