HORAK Consulting
Pharma, Medical Devices, Food & Cosmetics
My Services
Medicinal Products
- Regulatory Strategies
- Contract Manufacturer Contacts
- Labelling & Packaging
- CMC Documentation (IMPD/CTD)
- Stability Studies (ICH)
- GAP Analysis & CTD Writing
Medical Devices
- Conformity Assessment
- QM Support
- Dossier Creation
- Design Control Mentoring
- MDR Updates
- Clinical Evaluation
Quality Management
- GAP Analysis (GMP/ISO 13485)
- QMS Optimization
- SOP Writing & Review
- Audit Preparation
- Employee Training
- Change Control
GxP Services
- GDP Responsible Person (RP)
- QPPV (Pharmacovigilance)
- Scientific Information Officer
- Risk & CAPA Management
- Vigilance & MDR Training
Regulatory & Validation
- Borderline Classification (Product Safety)
- CCDS Creation
- Software Validation (Vault/Veeva)
- OQ & PQ Documentation
- Regulatory Intelligence
Cosmetics & Nutrition
- PIF Creation & CPNP Notification
- Food Labelling
- Product Strategies (FSMP)
- Contract Manufacturer Sourcing
- Advertising Material Approval
My EXPERTISE
Sound knowledge and practical expertise
I support pharmaceutical and medical device manufacturers as a regulatory affairs expert, interim manager and consultant. Together with you, I develop the right regulatory pathway to approval and build GxP and compliance structures that work in day-to-day practice. Especially in times of change – reorganisations, product transfers or new regulatory requirements – I provide clarity and reliability.
My Achievements
20+
Years in regulatory affairs
As Head of Regulatory Affairs at a Swiss family-owned company, I was responsible for the approval of critical care medicines – in close collaboration with clinicians. As Scientific Information Officer, I approve promotional materials for the entire DACH region, and as an interim manager I have supported companies through spin-offs and carve-outs. Through my network of IT specialists and regulatory professionals, I also support you with regulatory intelligence and the use of AI tools in regulatory affairs and the GxP environment.
20+
Companies supported
Class III
Approval experience since 2020
mRNA/RNAi
Product specialist at TÜV SÜD
Contact me
Mag. Dr. Alfred Horak
info@horak-consulting.at
Phone
+43 (0) 699 1002 0213
Address
Türkenkellerweg 9/5, 2413 Berg
In-between tones
To close, something personal: short sound sketches I composed myself. The titles are borrowed, with a wink, from everyday regulatory life – free of side effects, no marketing authorisation required.
Placebo That Works
Works even without an active ingredient.
CAPA Cabana
Deviation detected,
hip swing initiated.
The Audit Never Sleeps
Even the silence gets documented.
Signal Detected
Vigilance is listening.
Please Do Not Unblind
This sound stays double-blind.