References

What my customers value

The following references give a grounded impression of typical projects in recent years. I would be happy to talk to you about your specific request!

We‘ve been relying on Sven's pharmaceutical expertise right from the start – and he safely guided us all the way to the launch of our first products!

Reinhold Rombach

Founder and Managing Director BEH Klostergarten Pharma GmbH - pharmaceutical company, manufacturer and distributor of herbal medicinal OTC products based on the monastic medicine


Project

Consulting, concept design and development of all pharmaceutical structures for a pharmaceutical company, including selection and implementation of service providers, development of the entire supply chain and licensing of the start portfolio, obtaining the manufacturing authorization for market release according to § 13 (1) German Medicinal Products Act

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    Initial situation:

    • Concept design and development from scratch after foundation of the company (start: 2021)

    Task:

    • Development of a concept for setting up the structures and processes for a pharmaceutical company, distributor of herbal medicinal OTC products (pharmacy-only)
    • Selection and qualification of service providers, e.g. in the field of pharmacovigilance and regulatory affairs, implementation of the Qualified Person for Pharmacovigilance (§ 63 German Medicinal Products Act), the Information Officer (§ 74a German Medicinal Products Act)
    • Establishment of a QM system to obtain a manufacturing authorization for market release according to § 13 (1) German Medicinal Products Act, providing the function as Qualified Person according to § 14 German Medicinal Products Act (Directive 2001/83 EC) and interim management of other drug law functions
    • Evaluation and qualification of the entire supply chain, including contract manufacturers, contract laboratories and service providers for storage and distribution (transport) of medicinal products, supplier audits

    Methodology:

    • Workshop, preparation of a concept paper
    • Development of a QM system, preparation of all GxP-relevant documents
    • Accompanying the approval inspection to obtain the manufacturing authorization for market release according to § 13 (1) German Medicinal Products Act
    • Interim management, provision of drug law functions
    • Support in setting up internal employee structures, including training
    • Consulting for the selection of the start portfolio with herbal medicinal products, arranging contacts with license providers
    • Support and monitoring of regulatory affairs, transfers and new authorizations or registrations
    • Set-up for the manufacturing, testing and distribution of authorized or registered medicinal products, auditing of service providers
    • Arranging contacts in the field of marketing and sales of medicinal OTC products

    Aim/solution:

    • Establishment of a new pharmaceutical company (MAH, distributor), including all internal and outsourced structures
    • Acting on the market as a manufacturer by obtaining the manufacturing authorization for release according to § 13 (1) German Medicinal Products Act, provision of the QP function
    • Consulting for selecting the start portfolio, transferring or obtaining authorizations or registrations (MAH) for herbal medicinal products
    • Evaluation and qualification of the entire manufacturing, testing and distribution process
    • Realization of the market entry 2023
    • Ongoing consulting for the management

With Sven's support, we've achieved access to the market!

Sebastian Blöte

Managing Director Materia Deutschland GmbH (until 2022) – Wholesaler and manufacturer (release) for medicinal cannabis




Project

Obtaining a wholesale licence according to §52a German Medicinal Products Act and a manufacturing authorization according to §13 (1) German Medicinal Products Act with an import authorization according to §72 German Medicinal Products Act. Obtaining a licence to handle narcotics according to §3 German Narcotic Drugs Act. AMRadV applications (Germany) for irradiated cannabis.

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    Initial situation:

    • Start-up, conceptual design and development of pharmaceutical structures and processes "from scratch" (start 2018)

    Task:

    • Consulting and conceptual design of pharmaceutical structures and processes, in particular
    • Conceptual design of the quality management (QM) system
    • Preparation of QM manual, Site Master File (SMF), all Standard Operating Procedures (SOPs), job descriptions
    • Interim management, including head of quality assurance
    • Assumption of drug law functions: Responsible Person Wholesale, Responsible Person Narcotics, Qualified Person (QP), Qualified Person for Drug Safety/Pharmacovigilance (QPPV)
    • Qualification of service providers and supply chain, audits in Germany and abroad
    • Consulting for the continuous development of the pharmaceutical area

    Methodology:

    • Conceptual design of workshops
    • Interviews with relevant stakeholders
    • Technical realization, documentation
    • Bringing in network contacts to build up external structures and the supply chain
    • Interim management

    Aim/solution:

    • Establishment of internal and external structures
    • Development and establishment of a QM system
    • Obtaining the wholesale licence according to §52a German Medicinal Products Act, GDP certificate 2020
    • Obtaining the manufacturing authorization according to §13 (1) German Medicinal Products Act, GMP certificate and import authorization §72 German Medicinal Products Act, 2021
    • Obtaining the licence to handle narcotics according to §3 German Narcotic Drugs Act, 2020
    • AMRadV marketing authorization (Germany) and maintenance (variations)
    • Interim management, realization of market entry
    • Accompanying consulting of the operative business

Restructuring our QM system, Sven has set an important course for us for the future to ensure our compliance!

Lars Dörhage

Managing Partner Med-X-Press GmbH –

Logistics fulfillment provider and outsourcing partner for the active temperature-controlled storage and distribution of pharmaceuticals – including narcotics – healthcare products and advertising materials


Project

Restructuring and update of a quality management system to GDP/GMP

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    Initial situation:

    • Grown structure and documentation, GDP warehouse, GMP manufacturing

    Task:

    • Reorganization of quality assurance, segregation of duties, establishment of a quality unit according to drug law requirements, assurance of GxP compliance

    Methodology:

    • Management consulting
    • Situation and gap analysis
    • Concept paper
    • Workshop with stakeholders
    • Interviews with employees
    • Conceptual design
    • Moderation of the kick-off meeting
    • Interim management
    • Realization of the Quality Unit with QA and QC
    • Support in setting up internal personnel structures (internal and external recruitment)

    Aim/solution:

    • Design and establishing of a Quality Unit
    • Modification or creation of new QM documents, implementation of Site Master File and SOPs as well as job descriptions of key personnel
    • Interface management
    • Verification of GDP/GMP compliance in various audits and inspections by authorities

Good to know the project in Sven‘s hands. His broad expertise and excellent network are crucial to gain our goals.

Arnold Schmied

Entrepreneur


Project

Development of a new Rx drug (MENA region)

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    Task:

    • Starting the project from scratch, initial consultancy

    Methodology:

    • Consulting of the investor group in all pharmaceutical issues
    • Scientific management
    • Comprehensive project management in preclinical, galenic development, IMP manufacturing and clinical trials
    • Selection and qualification of suppliers and service providers, incl. audits (DE, MENA)

    Achieved aim:

    • Testing and realization in galenic development
    • Production of an investigational medicinal product
    • Start of clinical phase
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