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Services

Grindeks has a wide sales network and great experience in the market as well as all resources necessary to provide contract registration services to meet the clients demands.

Regulatory Strategy Planning

Grindeks Regulatory Affairs services include strategic regulatory planning, according to individual client requirements, up to and including liaison of the client to regulatory agencies.

Regulatory Submissions and Support

Preparation, Compilation of Dossiers According to European Requirements and Evaluation of Documentation

Development of CTD modules:

  • Preparing of Module 4 & 5 for bibliographical references
  • Preparing of Module 3 for Pharmaco-chemical part
  • Writing Module 2 – Overviews of Pharmaceutical, Preclinical and Clinical Results; Expert Reports
Marketing Authorisation Applications Consultancy and Specific or Full Services

Via National Procedure:

  • Translation and comparison of SmPC to originator for generics
  • Translation and labelling of PIL
  • Review and completion of dossiers
  • Compilation of Module 1
  • Liaison with competent authorities
  • Advancing process by the procedures in different countries

 

Via Mutual Recognition Procedure (MRP) / Decentralised Procedure (DCP):

  • Application for national MA (MRP part)
  • Translation and comparison of SmPC to originator for generics
  • SmPC harmonisation
  • Translation and labelling of PIL
  • Review and completion of the dossiers
  • Compilation of Module 1
  • Securing the MA (national phase) and applying for the Assessment Report
  • Establishing “day 0”
  • Preparing the Response Volume
  • Steering CMS submissions
  • Liaison with competent authorities
  • Advancing processes by the procedures in different countries

 

Variation and renewal applications:

  • Renewal applications of a Marketing Authorisation
  • Type I-II Variation Applications of a Marketing Authorisation
  • Marketing authorisation transfers to a new holder
  • The package leaflets and labelling amendments
  • Packaging material design correction & proofreading
Regulatory Specialisation – Russia, Ukraine, Belarus and other CIS countries

Due to its location, Grindeks is well placed to provide the following services:

  • Compilation of dossiers according to regional requirements
  • Submission
  • Advancing of the procedure
  • Direction of the process in all of the stated countries
  • Liaison with Russia, Ukraine, Belarus and other CIS countries regulatory authorities
Product Information and Readability Test

Summaries of product characteristics (SPC), product information leaflets (PIL) and labelling:

  • Preparation, translation and updating of texts
  • Packages printing process and package leaflets steering
  • Managing pan-CIS labelling projects

 

Readability testing of product information leaflets (PIL):

  • Readability tests of package leaflets in accordance with EU directives, especially to the findability, applicability and understandability of text
  • The entire testing from the preparation of the package leaflet up to the Final Report is handled. The issued signed Final Report will confirm that testing both, one by one and altogether has succeeded
  • Interviews, performed by professionals
  • Individually structured test designs; user tested interviews with independent observers and supervisor
  • All events are carefully prepared in close cooperation with the sponsor in accordance with the demographic situation of drug’s target (indicated) and/or current actual patient group
  • Grindeks is responsible for all stages of testing, including suggested amendments to the leaflet and test, and for all the listed items below

 

Readability tests run for four to six weeks and cover the following areas:

  • Writing the protocol
  • Writing the test questions
  • Preparing the questionnaires
  • Defining the target group
  • Enrolling of volunteers into the target group
  • Checking the questionnaire with a pilot test involving 1-3 patients
  • Performing interviews with at least 20 patients in two separate rounds
  • Performing statistical analyses
  • Correction of the patient leaflet
  • Repeating the interviews
  • Evaluation
  • Writing the summary
  • Preparing the document for submission to the authority
  • Translation of the document into English
  • Loan translation of the approved patient leaflet
Translations, Proofreading and Editing
Professional translators of Grindeks will translate documents related to regulatory affairs:
  • All parts of a final dosage form dossier
  • Summaries of product characteristics
  • Package leaflets and labellings
  • Authority statements and decisions

Services in English, Russian, Latvian.