Silvia Kulmer

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Consulting
- Consulting
  Understanding Markets
  
  Understanding Markets
  
  Designing Innovations
  
  Designing Innovations
  
  Establishing Processes
  
  Establishing Processes
  
  Let’s break new ground together.
  Turning tricky regulations into opportunities — creative ideas, clear paths, strong partnerships, and effective products for sustainable success in the healthcare market.
  To Consulting
Consulting
Turn tricky regulations into opportunities – with products that deliver sustainable success in the healthcare market.
Product Areas
- Medicinal Products
  Taking Responsibility
  
  Marketing Authorisation Holder
  
  Marketing Authorisation Holder
  Diapharm assumes the role of the marketing authorisation holder on behalf of manufacturers and distributors.
  
  Qualified Person for Pharmacovigliance
  
  Qualified Person for Pharmacovigliance
  Every pharmaceutical company in Germany is required to appoint a Qualified Person for Pharmacovigilance (QPPV) with the competent authority.
  
  Information Officer
  
  Information Officer
  A Graduated Plan officer must manage the pharmacovigilance system, assess risks, and coordinate measures to ensure patient safety.
  
  Batch Release & Qualified Person
  
  Batch Release & Qualified Person
  Within Diapharm's manufacturing and import authorisation, Qualified Persons carry out the batch release of medicinal products.
  
  Taking Responsibility
  Diapharm provides information officers, graduated plan officers, qualified persons, and manufacturing functions.
  See Overview
  
  Regulatory Affairs
  
  Marketing Authorisation
  
  Marketing Authorisation
  Diapharm develops an appropriate marketing authorisation strategy, taking into account the various procedures.
  
  eCTD Dossier
  
  eCTD Dossier
  For existing documentation, Diapharm takes care of maintenance and the necessary (re-)formatting into the eCTD/CTD format.
  
  Environmental Risk Assessment
  
  Environmental Risk Assessment
  Environmental risk assessments are used to evaluate whether active substances or other components may pose a risk to the environment.
  
  Readability User Test
  
  Readability User Test
  A prerequisite for marketing authorisation is the conduct of readability tests to ensure that patients understand the package leaflet.
  
  Rx to OTC Switch
  
  Rx to OTC Switch
  Diapharm advises and supports clients in the planning, strategic approach, and implementation of Rx-to-OTC switches.
  
  Due Diligence
  
  Due Diligence
  Regulatory due diligence is the regulatory assessment of investment decisions in the healthcare products industry.
  
  Regulatory Affairs
  Together with its clients, Diapharm defines project objectives and identifies the optimal regulatory pathway to achieve them.
  See Overview
  
  Development and Licensing
  
  Development and Licensing
  Diapharm develops OTC medicinal products for the industry and arranges suitable existing marketing authorisations and licences.
  
  Investigational Medicinal Products (IMPs) 
  
  Investigational Medicinal Products (IMPs) 
  During a clinical trial, investigational medicinal products (IMPs) are used and tested.
  
  Quality Management (GxP)
  
  GMP Consulting & Audits
  
  GMP Consulting & Audits
  Diapharm supports clients in the effective and efficient compliance with GMP guidelines.
  
  Quality Management System
  
  Quality Management System
  Diapharm handles the implementation and maintenance of quality management systems based on GDP and GMP guidelines.
  
  Risk Management & FMEA
  
  Risk Management & FMEA
  Pharmaceutical quality risk management should be appropriate in scope, form, and documentation to the level of risk.
  
  Manufacturing and Import Authorisation
  
  Manufacturing and Import Authorisation
  Pharmaceutical distributors or marketing authorisation holders without a manufacturing authorisation require a wholesale distribution authorisation for their activities.
  
  API Audits
  
  API Audits
  Diapharm ensures cost-efficient auditing of suppliers of pharmaceutical active substances (APIs) and excipients.
  
  Quality Management (GxP)
  Diapharm is a consulting company for pharmaceutical quality management, quality control, and quality assurance.
  See Overview
  
  Scientific Information
  
  Information Officer
  
  Information Officer
  A Graduated Plan officer must manage the pharmacovigilance system, assess risks, and coordinate measures to ensure patient safety.
  
  Scientific Information
  Labelling of packaging, the summary of product characteristics, instructions for use, and promotional materials must comply with legal requirements and the marketing authorisation dossier.
  
  Pharmacovigilance
  
  Pharmacovigilance System
  
  Pharmacovigilance System
  The Qualified Person for Pharmacovigilance (QPPV) is responsible for ensuring that a pharmacovigilance system is in place within the company.
  
  Qualified Person for Pharmacovigliance
  
  Qualified Person for Pharmacovigliance
  A Qualified Person for Pharmacovigilance (QPPV) must manage the pharmacovigilance system, assess medicinal product risks, and coordinate measures to ensure patient safety.
  
  Risk Management Plan
  
  Risk Management Plan
  Pharmaceutical risk management should be appropriate in scope, form, and documentation relative to the level of risk.
  
  PSURs
  
  PSURs
  For active substances requiring Periodic Safety Update Reports (PSURs), Diapharm prepares up-to-date, substance-specific PSURs.
  
  Pharmacovigilance
  In matters of drug safety, Diapharm is a reliable partner for the pharmaceutical industry.
  See Overview
  
  The Diapharm Philosophy to medicinal products
  Diapharm supports clients in the development and market introduction of medicinal products and ensures their quality and safety throughout the entire product life cycle.
  To Medicinal Products
- Medical Devices
  Taking Responsibility
  
  Taking Responsibility
  On behalf of our clients, Diapharm acts as the responsible manufacturer in accordance with the MDR and IVDR.
  
  Clinical Evaluation
  
  Clinical Evaluation
  A clinical evaluation is mandatory for all medical devices in accordance with the Medical Devices Regulation (MDR).
  
  Conformity Assessment
  
  Conformity Assessment
  At the end, the manufacturer’s declaration of conformity and the authorisation to place the product on the market with the CE marking are issued.
  
  Maintenance
  
  Maintenance
  Diapharm ensures the monitoring and maintenance of conformity for medical devices and in vitro diagnostics throughout the product life cycle.
  
  Combination Products
  
  Combination Products
  For medicinal products, Directive 2001/83/EC and Regulation 726/2004 apply; for medical devices, Regulation 2017/745 (MDR) applies.
  
  HÄLSA Pharma GmbH
  
  HÄLSA Pharma GmbH
  
  The Diapharm Philosophy to medical products
  As the legal manufacturer, Diapharm assumes all regulatory responsibilities and brings medical devices to market quickly and efficiently.
  To Medical Devices
- Food Supplements
  Borderline Issues
  
  Borderline Issues
  Diapharm understands the requirements for food supplements, balanced diets, medicinal products, medical devices, and cosmetics, and develops strategies accordingly.
  
  Portfolio Strategy
  
  Portfolio Strategy
  Diapharm analyses existing product portfolios of food supplement manufacturers and provides guidance for further development.
  
  Verification of Marketability
  
  Verification of Marketability
  Whether a food product — a food supplement or a specialty food — is marketable involves many aspects.
  
  Product Labeling
  
  Product Labeling
  Diapharm supports complete and accurate labelling and helps to prevent non-compliance issues.
  
  Health Claims
  
  Health Claims
  Making a health-related claim for a food product is not optional; it is subject to strict regulations.
  
  The Diapharm Philosophy to food supplements
  Diapharm advises manufacturers of food supplements, foods for special medical purposes (FSMP), and specialty foods.
  To Food Supplements
- Cosmetics
  Labeling
  
  Labeling
  In the labelling of cosmetic products, a distinction is made between mandatory labelling and voluntary information.
  
  Notification
  
  Notification
  Cosmetic products must be notified before being placed on the market, as required by the EU cosmetics regulation.
  
  Product Information File
  
  Product Information File
  When a cosmetic product is placed on the market, the responsible person is obliged to maintain a product information file.
  
  The Diapharm Philosophy to cosmetics
  Diapharm advises and supports providers of medical skincare products in portfolio analysis, as well as in the development, evaluation, and regulatory implementation of their products.
  To Cosmetics
Product Areas
These are the product areas of Diapharm.
Company
- About Diapharm
  People
  
  People
  More than 100 specialists are committed to our clients’ projects, think strategically, and ensure the smooth execution of all tasks.
  
  Company History
  
  Company History
  For 37 years, Diapharm has delivered impressive, forward-looking and creative strategies — both nationally and internationally.
  
  About Diapharm
  
  Learn more about Diapharm.
  
  Diapharm supports the pharma and life sciences industry as a consulting firm – creating market access and value.
- Downloads
  
  Downloads
  General information, brochures, certificates, or presentations. We also make all current materials available for download.
- Contact
  
  Contact
  Consulting is dialogue. Clarity arises only through conversation — open exchange is the foundation of good consulting.
Company
Diapharm supports the pharma and life sciences industry as a consulting firm – creating market access and value.
Blog
To the Blog
News, insights, surprises: Stay informed about all product areas.
See Overview
References
References
An overview of Diapharm references.
Career
Career
At Diapharm, positions aren’t stiffly defined — each individual shapes their own.