Dossier Data Conversion
We use an advance software to convert your dossier from any format to eCTD formart as stipulated in European Medicines Agency regulation and local regulatory agency guidelines to be acceptable dossier format. After conversion we also localise your dossier documents to countries of choice.
Once your dossier is converted to common technical data CTD and electronic common technical data eCTD, such dossier becomes reusable in future, should you intend to divest license or register in other regions including emerging markets.
Dossier Gap Analysis
In the current climate, the ever increasing number of company mergers, acquisitions and in/out-licencing deals means that the area of Due Diligence is becoming more important throughout the pharmaceutical industry.
The Marketing Authorisation Holder (MAH) has ultimate responsibility for all its medicinal products marketed within the EU. We see the results of inadequate due diligence on a regular basis, finding, often at a late stage that the acquired dossier:
- Is incomplete.
- comforms with current regulatory guidelines.
- is consistent with already submitted version
Penalties imposed by regulatory authorities on companies failing to ensure regulatory compliance have included fines, withdrawal of an MA, product recalls or disruption to product distribution at a regional level.
For dossiers before registration and for products already commercialised, our review would aim to indentify and record and offer solution for:
- Dossier completeness
- Any formatting issues (electronic, CTD)
- Compliance with current EU guidelines / legislation
- On-going regulatory issues (pending variations,)
- Any outstanding regulatory commitments (eg stability data)
- Compliance of Product Information (PI)
- Regulatory actions required
Dossier Technical Writing
We work with your regulatory affairs staff to ensure that your dossier is up too date and help you write missing or incomplete modules before submission, below are how we could help you with your dossier modules:.
In module 1; We provide technical assesment of formating, completness and fix any ommission and facilitate the certifications as may be needed for target local authority.
Module 2; Our role is to analyse all aspects of this module ensuring corrolation with susequent modules where there are gaps, we flag such gap and suggest corrective actions as solution and as a matter of fact, we also take a step further to advice your experts on how to identtify and prevent gap from occuring in the first place. We have the expertise to write Module II from scratch.
Module 3; Most of our partners do not have much issues with their chemical, manufacturing nd control data, however we are ready to work with our partner CMO’s to complete M3 and perform necessary adaptations and analytical tests.
Module 4; Module 4 presents the non-clinical reports included in the dossier. The structure and content of Module 4 is specified in the ICH M4S guidelines.7 The main headings in this section (that must not be altered) are as follows:
- Non-clinical study reports
- Summary pharmacology report
- Pharmacokinetics inference report
- Toxicology report
- Literature references used in Module
Module 5; which provided a specific placement of clinical study reports and related information to simplify preparation and review and to ensure completeness. The placement of a report is determined by the primary objective of the study, with each report appearing in only one section. If there are multiple objectives, the study should be cross-referenced in the various sections.
Reports of studies pertinent to pharmacokinetics using human biomaterials
- summary report of human pharmacokinetic
- Summary reports of human pharmacodynamics
- Summary reports of efficacy and safety studies
- Case report and individual and patient listings
- Search and report of Literature references
User Readability Testing of Patients’ Informtion Leaflet
For a complete dossier to be accepted for marketing authoriation, the patient information leaflet must be readable by patients who will consume your product. We conduct user testing for your product PIL in order to ensure readability, comprehensibility and clear formating in accordance with European medicines agency EMA guidelines.
European Directive 2001/83/EC on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC requires that the results of assessments carried out in cooperation with target patient groups shall be provided to the competent authority. It is also required that package leaflet should be easy to read and users should be able to find any relevant information quickly and easily. All information should be given in clear and understandable terms and instruct the patient effectively how to act appropriately in different situations. We perform this test in accordance with: European Commission’s “A Guideline on the Readability of the Label and Package Leaflet of Medicinal Products for Human Use” (European Commission, Revision 1, 12 January 2009) and the “Guidance concerning consultations with target patient groups for the package leaflet” (May 2006), and the “Guidance on the user testing of patient information leaflets” (MHRA, June 2005).
Next step is to support your experts in submitting your now complete and correct dossier to local regulatory authority and follow up with communication, advising you on any diviations and deffiency that might be flagged.during registration process, we work with you and interface with local regulatory agency in EU member states, Russia and CIS regional countries until marketing authorisation is granted.
After obtaining marketing authorization and or during commercialization of the registered medicinal product, sometimes manufacturers realize and propose any changes to the registered dossier; in some cases such changes could be administrative or quality, those proposed changes must be informed to Health Authority (HA) by filing supplements or variations or amendments, which are referred as post-approval life cycle management.
Post approval life cycle maintenance could be categorized into:
|Type II/Type C||Major Changes||require approval from health authorities prior to distribution |
|Type IB/Type IAIN/ Type B||Moderate Changes||require approval from health authorities prior to distribution |
|Type IA/Type A||Minor Changes||do not require prior approval from health authorities|