Medical Devices Regulatory Affair’s

Pharmazone is a consulting company, specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry.  With our wealth of experience in the field, Pharmazone is the ideal partner for all your RA/QA concerns:

• CE-marking of your devices
• Authorized Representative in the EU
• Quality Management System implementation & QMS Gap analysis
• Performance Studies for IVD
• Review and composition of Technical Documentation
• Review Instructions For Use and labels
• Assistance in Notified Body selection
• Preparation for conformity assessment by Notified Body
• Classification products
• Scientific validity reports

Readability testing

• We specialize in readability user tests and demonstrate the readability of the patient information leaflets for your medicinal product using consultations with target patient groups.
• We can help you with all issues related to readability testing and assessment of patient information leaflets following European specifications.

Carrying out the readability user test It is carried out in English, German and each of the other official EU languages following SLESS and WISEMAN.

Labeling Artwork preparation

• We provide innovative, cost-effective, and creative graphic design & artwork services to support new product launches and brand re-designs for global life sciences companies.
• Our artwork pack management services deal with artwork lifecycle management of any product including leaflet, carton, and label starting from initiation to the production of the packaging artwork.
• We also offer artwork services for content to the carton, private labelling and primary and secondary packaging, which include all printed materials associated with the products e.g., containers, cartons, foils, tubes, inserts, packets, and shippers.

RTR support

• Our expert team is capable of supporting the submission with complete RTR support to the regulatory applicants.

Due diligence of dossier

Review and verification of regulatory dossier for appropriateness as per regulatory authority requirements:

• CTA and IND application
• NDA and ANDA application
• BLA and MA application
• ECTD dossier

Local agent support

According to EU regulations, medicinal products imported into the European Economic Area (EEA) from third countries have to be certified by a Qualified Person (QP) before releasing into the market. Similarly, US FDA regulations require US agents for FDA communication for organizations outside the USA. We offer the following:

• Representative to represent clients on FDA/MAA interactions.
• Assist with FDA/MAA preparations and Advisory meetings
• Provide clients with an ‘FDA/MAA style’ review of submissions
• Advice on regulatory options and potential pathways

Batch testing

Our consulted laboratories are GMP certified and they have a manufacturer authorization for Quality Control purposes. We can offer the following services:

• APIs Certificate of Analysis as per Pharmacopoeias
• Individual parameter determination to be included in COA
• Full analysis of all parameters to issue a standalone COA
• Batch Testing of clinical batches
• Batch Testing of marketing batches
• Import medicinal drug products (human, veterinary or investigational) into the EU

Batch Release

According to EU regulations, medicinal products imported into the European Economic Area (EEA) from third countries have to be certified by a Qualified Person (QP) before releasing into the market. We offer the following:

• Manufacturing plant certification for EU-GMP compliance
• QP declaration for regulatory purposes
• Import of batches
• Batch Testing and Certificate of Analysis