AaMEDI offers Quality Assurance and Regulatory Sevices for Pharma companies 


AaMEDI Quality Assurance Services

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Swissmedic

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AaMEDI offers Responsible Person RP FvP / QP services

Every Pharma company in Switzerland with Swissmedic licenses must employ a Responsible Person RP (Responsible Person, Fachtechnisch verantwortliche Person, FvP). The RP must follow in his tasks EU-GDP Guidelines as well as all Swissmedic regulations. The qualification of the RP is defined in AMBV.   

RP FvP QP tasks and responsibilities

- Continuously quality management meetings
- Creating and maintaining GDP Quality system
- Handling of GDP Documentation and records
- Creating, maintaining, training, releasing and archiving of SOPs
- Creating and signing Technical quality agreements
- Checking commercial agreements
- Creating and maintaining Job descriptions
- Monitoring GDP transports / temperature releasing
-  Performing Supplier audits and qualifications
-  Performing Customer qualifications9
- Swissmedic Inspections, Contact person towards authorities  
- Preparing license applications to Swissmedic
- Performing internal and external audits
- Handling of Complaints, Deviations and Return of Goods
- Performing Risk and Recall Management
- Handling of all Wholesale Operations
- Performing CAPA, Falsified medicines
- Management Reviews

Quality tasks

AaMEDI offers Quality Management Services

AaMEDI provides following QA services:
- Setup of quality system and implementation
- Maintain the quality system 
- Responsible Person (RP) / FvP
- RP deputy services / FvP Stellvertreter
- Qualified Person (QP) services
- Support in GDP/GVP/GMP-related issues
- Auditing services, site visits
- Technical Quality Agreements
- Swissmedic License Applications and all other Swissmedic issues


Quality Management System created by AaMEDI

Quality Management System is needed for all Pharma companies. AaMEDI offers whole Quality Management Systems (QMS) based on GDP/GMP and Swissmedic requirements for all Pharma customers.   

QMS typically consists of 

- Quality Manual Handbook
- Standard Operation Procedures
- Swissmedic Licenses, correspondence with Swissmedic
- Swissmedic inspection documentation
- Company profile and strategy
- Company's operating model
- Organizational Chart and Personnel
- Agreements with Partners
- Logistic strategy, supply chain
- Records and documents

AaMEDI performs Swissmedic License applications

AaMEDI can prepare for you the Swissmedic License applications. Following licenses are available:
- Manufacturing of pharmaceuticals
- Production of API's
- Wholesale of pharmaceuticals with release
- Wholesale of pharmaceuticals without release
- Import of pharmaceuticals with release 
- Import of pharmaceuticals without release
- Export pharmaceuticals
- Trade abroad
- Broker activities

More info

Swissmedic license


AaMEDI offers following Regulatory Services

AaMEDI offers international regulatory services in co-operation with our partners as follows
- Regulatory affairs filing
- Variations
- Submission of files
- Adaptation to the Swiss requirements
- Medical information / leaflets
- Packaging related questions
- Price negotiation for Switzerland
- Paediatric investigational palns
- Orphan designations
- Scientific advice
- Clinical trial application

Our Partners have 30 years of experience with international regulatory affairs and with Swissmedic.

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