 IGRS can provide SERVICES in many ways:
 Preparation of CTD Modules 1,2,3,4 and 5
DMF Preparation
Assessment of data for suitability for registration
Identification of deficiencies
Gap Analysis and remediation
Comparison of Summaries of Product Characteristics
Organisation of meeting with Reference Member State, accompanying the client
Updating the dossier including Expert Reports/Overviews, if necessary
Assuring validation of the dossier
Obtaining the Assessment Report from the RMS
Arranging translations and preparing documentation for each Concerned Member State
Provides regulatory due diligence for potential licensing opportunities in chemistry, manufacturing and control, preclinical and clinical research
Preparation of marketing authorisation application
Submission of dossier and payment of fees
Receiving questions and co-ordination and preparation of suitable responses
If necessary, arranging an oral explanation, accompanying the client
Co-ordination and submission of responses
Liaison with the authorities until grant of marketing authorization.
Clarification of concerns and deficiencies at MRFG/Co-ordination Group
Advice on arbitration process
Organising final translations of SPC, PIL and labels in all official languages
Preparation and submission of colour mock-ups for finalised Patient Information Leaflet and labels
Submission of colour mock-ups.
Expert Reports/Overviews
Co-ordination of page numbering, photocopying, binding, and dispatch of dossier to the authorities
Literature search
Review of dossiers compiled by you for EU, before submission by our European counterpart.
IGRS team is qualified to advise on all the scientific disciplines required for successful registration in the EU and other territories. The team's vast regulatory experience includes many approvals via both Decentralised and MR routes. We also understand the importance of prompt and secure dispatch of dossiers to the authorities. Our extensive experience allows us to advise on the submission route and success factors in getting the application right first time.
Biotech: IGRS can provide experts with extensive industry experience in the licensing of biologic and biotech medicinal products
Product Literature & Readability Testing
SPC, PIL and Labeling Texts:
Good quality product literature is one of the keys to successful regulatory approval and attention to detail is important in writing the Summaries of Product Characteristics(SPC), Patient Information Leaflets(PIL) and Labeling texts. IGRS provides writing service for SPC, PIL and labeling texts. IGRS can advise on the regulatory requirements for both content and format under legislation as well as write or review the relevant texts.
We work with a team of high quality medical translators to provide product literature in all the languages of the European Union. Back-translations can also be provided to check for authenticity. Linguistic review of texts in any language can also be provided.
Artwork Creation:
Creation of the final artwork is also offered, including versions intended for the partially sighted. Artwork (colour mock-ups of the leaflet and labels, meeting all the applicable guidelines and suitable for submission to regulatory authorities) is provided as PDF files suitable for electronic submission.
A recent development throughout the EU is the legal requirement to provide the product name in Braille on the pack and to have available a version of the leaflet suitable for the partially sighted, such as large print or an audio tape. We can advise on both these topics as well as provide the Braille translation.
Readability Testing:
All Patient Information Leaflets for new products must be written in plain English and there is now a requirement in the EU for these to be user tested to ensure readability. IGRS can offer full Readability testing service and can prepare test reports suitable for submission. We also get it checked for consistency of the wording of the leaflet and the label with that of the SPC. |
