01
GDP & Regulatory Responsibility
Building and maintaining GDP-compliant wholesale structures in Germany — from § 52a AMG readiness to ongoing quality oversight.
- External Responsible Person
- GDP systems & SOPs
- Inspection readiness
Pharma · Germany · DACH
We make your path into the German pharma market possible.
GPA Pharma Advisory combines regulatory responsibility, operational leadership and commercial execution — for international pharmaceutical companies entering Germany and the DACH region.
Focus
HospitalCritical CareInjectablesOncology
GPA Pharma Advisory
Regulation, organisation and market — connected from day one.
A successful market entry does not end with a strategy. It requires clear responsibilities, robust quality systems, the right partners and experienced leadership. GPA connects these interfaces — focused, pragmatic and at eye level with management and operational teams.
Our expertise
Expertise where responsibility matters.
02
Quality Assurance & QMS
Pragmatic quality systems that translate regulatory requirements into robust, scalable and audit-ready operations.
- QMS setup & optimisation
- Audits & CAPA
- Supplier qualification
03
Interim Management
Temporary executive and operational leadership for demanding setup, transition and transformation situations.
- Interim executive management
- Operational leadership
- Transformation & setup
04
Germany & DACH Market Entry
An integrated entry strategy connecting regulatory feasibility, operating model and commercial reality from the outset.
- Go-to-market model
- Local organisation
- DACH roadmap
05
Business Development & Licensing
Structured assessment and development of growth opportunities with pharmaceutical insight and a long-term partnership perspective.
- In-/out-licensing
- Portfolio & partner assessment
- Negotiation support
06
Distributor Search
Identification and selection of suitable partners for Germany and DACH based on therapeutic, logistics and quality requirements.
- Longlist & screening
- Due diligence
- Partner onboarding
Market Entry
One market. Many dependencies. One clear path.
GPA structures your entry into Germany and DACH as one integrated programme: regulatory-ready, operationally realistic and commercially viable.
Discuss your market entry ↗Orientation
Align objectives, portfolio, regulatory status and market expectations.
Entry Design
Connect responsibilities, partners, licences and operations in one robust model.
Execution
Steer the setup, embed quality and activate the critical interfaces.
Leadership
Stabilise the organisation, create transparency and ensure a clean handover.
Therapeutic focus
Experience in markets where reliable supply matters.
Hospital products, critical care, injectables and oncology create specific demands across supply, quality, logistics and commercial execution. GPA aligns market entry and operations with these realities.
Hospital
Complex stakeholders, institutional procurement and reliable supply models.
Critical Care
High operational relevance and exacting requirements for availability and quality.
Injectables
Sensitive products, demanding supply chains and clear quality interfaces.
Oncology
Specialised portfolios, complex care pathways and demanding market access requirements.
Profile
“Taking responsibility means turning strategy into robust structures and reliable execution.”
Senior expertise. Personally committed.
GPA Pharma Advisory is led by Dr Andreas Gerold as an independent pharmaceutical advisor. He supports international pharma companies where strategic decisions, regulatory responsibility and operational leadership must come together.
Dr. Andreas Gerold
Independent Pharma Advisor · Interim Executive
When GPA is the right fit
When a market opportunity becomes an operational responsibility.
- You are planning to enter Germany or the DACH region.
- You need an external Responsible Person or GDP-compliant structures.
- You want to establish robust QMS, audit or quality processes.
- You require experienced interim leadership during setup or transition.
- You want to identify licensing or distribution partners systematically.
Contact
What does your next step require?
Let us discuss your project confidentially. In an initial conversation, we identify where GPA can provide fast orientation and effective support.
Contact Dr GeroldLegal Notice
Information pursuant to § 5 DDG
Responsible for the content of this website: Dr Andreas Gerold.
Service provider
Dr. Andreas Gerold
GPA Pharma Advisory
Bolthaus 63
40723 Hilden
Germany / Deutschland
Contact
Liability for content
The content of this website has been prepared with due care. As the service provider, we are responsible for our own content in accordance with the general laws. We cannot, however, guarantee that all information is complete, accurate or current. Mandatory statutory liability remains unaffected. If we become aware of a specific infringement, we will remove the relevant content without undue delay.
Liability for links
This website may contain links to external third-party websites whose content is beyond our control. The respective provider or operator is responsible for the content of linked pages. Links are reviewed for identifiable legal infringements when they are added. Continuous monitoring without specific indications of an infringement is not reasonable. If we become aware of an infringement, we will remove the relevant link without undue delay.
Copyright
The content and works created by the website operator are subject to German copyright law. Reproduction, editing, distribution or any exploitation beyond the limits of copyright law requires the prior written consent of the respective author or creator. Downloads and copies are permitted only for private, non-commercial use. Third-party rights are respected and third-party content is identified where applicable. Please notify us if you nevertheless become aware of a possible copyright infringement. Upon becoming aware of an infringement, we will remove the relevant content without undue delay.