Quality Assurance and Regulatory Sevices

Responsible Person services RP/FvP/ QP
Email: fvp@aamedi.com
 Quality Management System based on GDP / GMP
Email: regulatory@aamedi.com

AaMEDI Quality Assurance Services

quality tasks
Swissmedic
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AaMEDI provides RP / FvP / QP services

In Switzerland, every pharmaceutical company holding a Swissmedic licence must appoint a Responsible Person (RP), also known as the Fachtechnisch verantwortliche Person (FvP). The RP ensures full compliance with EU Good Distribution Practice (GDP) requirements and all applicable Swissmedic regulations. The qualifications and duties of the RP are defined in the Swiss AMBV.

Services:
.Setup and implementation of a complete Quality Management System
.Ongoing maintenance and continuous improvement of the quality system
.Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP) services
.Deputy RP / FvP deputy services
.Qualified Person (QP) services
.Support with GDP, GVP, and GMP compliance matters
.Auditing services, including on-site inspections and assessments
.Preparation and management of Technical Quality Agreements
.Swissmedic licence applications and full support with all Swissmedic regulatory matters

Swissmedic cerificated
One proof of our commitment to quality is that we have held Swissmedic-certified Responsible Person (RP/FvP) Mandates for over 20 years.
   

RP FvP QP tasks and responsibilities

.Leading ongoing quality management meetings

.Developing and maintaining GDP documentation and records

.Preparing, controlling, and archiving all GDP-related documents

.Creating, updating, training, approving, and archiving SOPs

.Drafting and signing Technical Quality Agreements (TQAs)

.Reviewing and overseeing commercial agreements

.Developing and maintaining job descriptions

.Monitoring GDP-compliant transport and temperature-controlled shipments

.Conducting supplier audits and qualifications

.Performing customer qualifications and assessments

.Coordinating Swissmedic inspections

.Acting as the primary point of contact for authorities

.Preparing and submitting Swissmedic licence applications

.Carrying out internal and external audits

.Managing complaints, deviations, and product returns

.Implementing risk management and product recall procedures

.Executing and following up on Corrective and Preventive Actions (CAPA)

.Overseeing all wholesale operations

…and more, tailored to your company’s needs.

Quality Management System created by AaMEDI

A Quality Management System (QMS) is essential for every pharmaceutical company. At AaMEDI, we provide comprehensive QMS solutions designed in full compliance with GDP, GMP, and Swissmedic requirements — ensuring our partners meet the highest industry standards.

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

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 of pharmaceuticals
- Broker activities

More info

Swissmedic license

AaMEDI provides Regulatory Services

AaMEDI provides 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 plans
- 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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