Regulatory Affairs

Our team of Regulatory affairs experts make our service offerings stronger.

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    Pre and Post Submission services
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    Stand-Alone Services
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    Intellectual Property Rights

Stand Alone Services

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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 in accordance with European specifications.

Carrying out the readability user test

It is carried out in English, German and each of the other official EU languages in accordance with SLESS and WISEMAN. For this purpose,

  • We prepare the product-specific questionnaire
  • We recruit subjects based on the target group and carry out interviews with the subjects in the form of a pilot test
  • If necessary, we optimize the patient information leaflet and carry out the main test with 20 subjects
  • We analyze the readability user test both qualitatively and statistically and
  • We prepare a final report in a submittal version for Module 1.3.4 in English.
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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 carton, private labeling and primary and secondary packaging, which include all printed materials associated with the products e.g., containers, cartons, foils, tubes, inserts, packets, and shippers.
  • Artwork capabilities of Pharmazone stretch across a multitude of areas such as: Consumer Healthcare, Pharmaceuticals, Cosmetics, Artworks for Primary Packaging Modes such as: Cartons, Foils, Tubes, Inserts, Packets etc., Secondary Packaging Artworks, Braille Artwork, Introducing Anti-counterfeiting Features to Artwork, Global Artwork Management System
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RTR support

  • Our expert team is capable of supporting the submission with complete RTR support to regulatory applicant.
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Due diligence of dossier

Support for regulatory dossier submissions around the world in both eCTD and non-eCTD formats:

  • Submitting CTA and IND applications
  • Writing, formatting and submitting eCTDs
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Local QP support

  • Represent clients in interactions with FDA
  • Assist with preparations for FDA and Advisory meetings
  • Provide clients with an ‘FDA style’ review of submissions
  • Advise on regulatory options and potential pathways
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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 according to the relevant Pharmacopoeias
  • Individual parameter determination to be included in your Certificate of Analysis
  • Full analysis of all parameters to issue a standalone Certificate of Analysis
  • Batch Testing and Batch Release of clinical batches
  • Batch Testing and Batch Release of marketing batches
  • Importation into the EU of medicinal drug products (human, veterinary or investigational)
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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) to be released into the market. Companies based in countries with Mutual Recognition Agreements have no obligation to retest the batches, although batch certification is always required. We offer:

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

Intellectual Property Rights

Our expert can help you in various segments including following.

 

  • Patent
  • Trademark
  • Copyright
  • Design
  • IP management
  • IP Analytics and Management
  • e-Discovery support