The eCTD is the standard format for submitting applications, amendments/ Variations, supplements, and reports to regulatory agencies. Most of the healthcare agencies including USFDA, EU regions, Canada require eCTD submissions.   The Common Technical Document (CTD) describes the organisation of modules, sections and documents to be used by an Applicant for a Marketing Authorisation for a medicinal product for human use agreed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).  The electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator.

• Dossier audit
• Dossier conversion from CTD/NeeS to eCTD
• Dossier module writing for MAA as per ICH :
• Module 1 – Administrative
• Module 2 – Overview and Summaries
• Quality
• Non-Clinical
• Clinical
• Module 3
• Module 4
• Module 5
• Dossier for MAA publishing in eCTD for various procedures like National, MRP, RUP, DCP and Submission by CESP

• Query response assistance while review when referenced to MAA application
• Assistance in response to request for additional information
• Support and assistance to overcome validation issues if any.
• Guidance in best procedure to adopt for filing a Marketing Authorisation Application (MAA)
• Submission MAA to European countries as per the schedule via National, MRP. DCP and CP and managing the complete procedure until approval and further life cycle management assistance.
• Interaction with regulatory health agencies for procedural matters.
• Booking slots for marketing authorization application for MRP and DCP.
• Module 2 writing for Clinical and Non-Clinical Overviews and Summaries
• Literature references for Module 4 and Module 5
• SmPC – Summary of Product Characteristics Preparation and harmonization of SmPC in QRD Format
• PIL – Product Information Leaflet – Preparation of PIL with its mock ups. 
• User testing of PIL (Readability studies) – Coordinating for its readability testing as per EFPIA General Recommendations for Readability User Testing of Package Leaflets for Medicinal Products for Human Use and MHRA Guidance on the user testing of Patient Information Leaflets.
• Translations for SmPC, PIL and  labelling

Variations-  At QW we understand the importance of life cycle management to a product’s success. From compliance activities to detailed strategies for line extensions, QW helps customer with all aspects of post-licensing activities and variations.  From minor administrative updates to new clinical indications and manufacturing changes, variations to approved products are of paramount importance throughout the product life cycle. QW has extensive experience of submitting variations globally across all types of changes. Type – I

• Type – IAIN
• Type – IA
• Type – IB

• Type – II

Renewals-  Periodic renewals of marketing authorisations are required globally. QW supports our clients by advising on requirements as well as managing the entire renewal process across multiple markets. Transfer of Ownership and Divestment-  QW has extensive experience supporting clients who wish to sell or acquire products globally, ensuring that the marketing authorisations are transferred to the buyer per the agreed timelines and with minimum disruption to ensure a seamless transition in the marketplace. QW can also provide support during the public offering, responding to questions in Due Diligence and inputting into the contracts where needed.

Labelling is an interdisciplinary function that serves as the basis on which prescribing information, advertising, and promotional materials for the medication are henceforth created. Pharmaceutical product labelling is a complex process that involves multiple products and markets for different formulations and dosages, maintaining pharma labelling compliance throughout the process.

• We support with – 
• Creation of Core Patient Information Leaflet. 
• Preparation, review and submission of Impacks or text version of the artwork.
• Harmonize safety information with reference product. 
• Creation of artwork for all kind of labels including but not limited to blister, bottle label, carton label and leaflet artwork.