Regulatory Solution

 

Regulatory Applications - MAA application

  • Marketing authorisation of medicinal products (via national, decentralised and MRP procedures)
  • Regulatory submission and liaising with agencies
  • Gap analysis of dossier
  • We take your raw data and transforming it into the appropriate file types that are required by the Competent Authorities for regulatory submission.
  • We can handle National, DCP, MRP, Duplicate license application
  • We can help in preparation and submission of dossier package for life-cycle maintenance activities i.e. Variation (Type IA, IB and II variations), renewal

Dossier Module Writing

Our cross-functional team can provide you with the complete solution, from due diligence reviews to Expert modulewriting (Module 1-5), we can provide you with the required documents you need to gain approval.

Electronic Submissions (eCTD or NeeS)

We continually monitor developments ensuring we are at the forefront of the latest electronic submission requirements of different authority. As per your requirement, we can prepare for your MAA application or and life-cycle maintenance activity i.e. variation or renewal;

  • eCTD
  • NeeS

Administrative and formatting services: document formatting (MS Word, PDF and etc.), scanning of paper documents, OCR, bookmarking and hyperlinking, preparation of media, validation, eCTD compilation and publishing.
We submit our applications via CESP or other Competent Authority portals to ensure courier costs are maintained as low as possible for you.

Overview of eCTD

The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information.  eCTD electronic submissions were first accepted by the European Medicines Agency in 2003. As part of the EMA’s move to an electronic submission system, they no longer accept paper-based applications for products applying to the centralised procedure.  Since January 2016 all electronic submissions must be in the eCTD format.
All other authorities are updating their guideline and making eCTD compulsory for submission. We can provide you eCTD service as best price.

Medical writing

We provide accurate medical writing service for regulatory submissions, scientific communications and medico-marketing materials for a diversity of therapeutic areas, and for all the stages of the product life cycle - from pre-clinical development to post-marketing literature.

  • Module 2.4 - 2.7 preparation 
  • Environmental Risk Assessment (ERA)
  • Clinical Trials Documents
  • Protocols
  • Investigative brochure / Product Manual 
  • Clinical study report (CSR)
  • Investigational Medical Product Dossier (IMPD)
  • Informed Consent Form
  • Case Record Form
  • CTD Documents
  • Module 4 & 5 review
  • Product information - SPCs and PILs, Pack Inserts
  • Gap Analysis of medical writing

Readability Testing of PIL and Bridging

Considering directive 2001/83/EC, amended by directive 2004/27/EC and legislations which regulate pharmaceuticals marketing rights extension and renewal, we remind you that it is obligatory to do Package Leaflet (PL) readability testing or to produce bridging reports for all pharmaceuticals.
Since 2005, all manufacturers of medicinal products must pay special attention to the readability test process as it has been a legal requirement in European countries in order to obtain the approval for their product.

Our readability test services include:

  • Evaluation of PIL to check if the readability testing is needed or bridging report will be sufficient
  • A thorough review of the text and layout of the product information leaflet (compliance with QRD template according to the procedure – CP, DCP, MRP or national submission – checking of grammar, spelling, clarity)
  • Development of Questionnaire and protocol
  • Screening and recruitment of suitable participants
  • Pilot test performed by an experienced interviewer
  • Further development of the PIL based on the pilot test results
  • Full readability test on 20 participants native in the language
  • Submission of a complete report including all test results

Gap Analysis

We’re here to close the gap. We identify the gaps between your registered details and current ways of manufacturing, record the outcomes and identify the tasks that you need to do, to close this gap. Once we have agreed the remediation strategy with you, we can create the relevant product applications and close that gap efficiently and with ease.