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Katja Pečjak
Vito Strasberger
Peter De Mayo Billev
Alenka Dražumerič
Ana Kraigher Tkavc
Sebastjan Reven
Jana Brajdih Čendak
Klemen Rojnik
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Chameleon
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Vigilance for Medical Devices
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Quality / GxP
GCP / VICH GL9 GCP / ISO 14155
GDP and RP
GMP and QP
Team of experts
Our experts
Peter De Mayo Billev
Katja Pečjak
Ana Kraigher Tkavc
Sebastjan Reven
Jana Brajdih Čendak
Klemen Rojnik
Nina Evelina Keršmanc
Chameleon
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Human medicines
Veterinary medicines
Vigilance for Medical Devices
Medical Consultancy
Clinical studies
Quality / GxP
GCP / VICH GL9 GCP / ISO 14155
GDP and RP
GMP and QP
Team of experts
Our experts
Peter De Mayo Billev
Katja Pečjak
Ana Kraigher Tkavc
Sebastjan Reven
Jana Brajdih Čendak
Klemen Rojnik
Nina Evelina Keršmanc
Chameleon
About us
News
Contact us
Home
Services
Regulatory Affairs
Human medicines
Veterinary medicines
Medical devices
Food supplements
Food for Specific Groups
Cosmetics
Biocides
Pricing and Reimbursement
PharmacoVigilance
Human medicines
Veterinary medicines
Vigilance for Medical Devices
Medical Consultancy
Clinical studies
Quality / GxP
GCP / VICH GL9 GCP / ISO 14155
GDP and RP
GMP and QP
Team of experts
Our experts
Katja Pečjak
Vito Strasberger
Peter De Mayo Billev
Alenka Dražumerič
Ana Kraigher Tkavc
Sebastjan Reven
Jana Brajdih Čendak
Klemen Rojnik
Nina Evelina Keršmanc
Martina Božíková
Chameleon
About us
Menu
Home
Services
Regulatory Affairs
Human medicines
Veterinary medicines
Medical devices
Food supplements
Food for Specific Groups
Cosmetics
Biocides
Pricing and Reimbursement
PharmacoVigilance
Human medicines
Veterinary medicines
Vigilance for Medical Devices
Medical Consultancy
Clinical studies
Quality / GxP
GCP / VICH GL9 GCP / ISO 14155
GDP and RP
GMP and QP
Team of experts
Our experts
Katja Pečjak
Vito Strasberger
Peter De Mayo Billev
Alenka Dražumerič
Ana Kraigher Tkavc
Sebastjan Reven
Jana Brajdih Čendak
Klemen Rojnik
Nina Evelina Keršmanc
Martina Božíková
Chameleon
About us
+386 123 22095
billeveast@billeveast.com
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Preparation and maintenance of a quality management system
Management of authorised activities and the accuracy and quality of records
Initial and continuous training
Coordinating and promptly performing any recall operations for medicinal products
Managing customer complaints
Selection and approval of suppliers and customers
Managing and approving any subcontracted activities which may impact on GDP
Self-inspections
Keeping appropriate records
Deciding on the final disposition of returned, rejected, recalled or falsified products
Approving any returns to saleable stock
Compliance with any additional requirements imposed on certain products by national law
GDP audits and preparation for inspections
RP APPROVED by Health Authority
Quality / GxP
GCP / VICH GL9 GCP / ISO 14155
GDP and RP
GMP and QP