Regulatory Services

Regulatory Support

As a result of highly regulated and competitive market worldwide, our network offers Regulatory Affairs services for medicinal products, GMP certification, product registrations.

We work on national levels registration to fulfill our clients’ expectations and demands for marketing authorization applications, preparation and updating of SmPC, package leaflets and labeling, variations and renewals, readability and user testing and many more.

We linking together a legacy of expertise to navigate the complex regulations and registration processes necessary to test new Drug Products and bring them to market. Experienced, on-site Regulatory Affairs teams ensure regulatory compliance by preparing and maintaining regulatory documentation such as:

>> CMC Quality Module Documentation in CTD Format Suitable for the Submission of IND, IMPD, NDA, and MAA Dossiers

>> EP-Certificates of Suitability (CEP)

Inthera PharmaMed in partnership with sister pharma group at Seatrack International Group anufacturing plants and the ability to develop APIs, Finished Dosage and Packaging in our network of facilities allows clients full access to integrated services, resulting in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines

Our facilities support customers with on-site regulatory affairs personnel for the documentation of CMC development projects in the CTD format for convenient inclusion in IND / IMPD / NDA / MAA filing dossiers.

Regulatory Consulting Services

> Submissions (National, CP and DCP)

We reformat and submit your pharmaceutical’s dossier to any member state in eCTD or CTD format.

Submissions at National Level

  • We can submit your dossier in your respective counntry
  • RMS and CMS services
  • 3rd party representation

Pharmaceutical Regulatory Strategies

  • Coordination and scheduling for DCPs, MRPs, CPs and National Procedures
  • We can coordinate DCP slots with certain agencies

> Dossier Compilation / Quality Overview

Our regulatory managers have proven their experience in coordinating and completing recognized regulatory procedures.

Dossier Compilation and Quality Overview Services

We offer:

  • Quality overviews by a senior regulatory manager prior to submission to be prepare for MRP, DCP or CP
  • Dossier reformatting to eCTD
  • Clinical and non clinical overviews

> Post-Approval License Maintenance

We work on-site as well as off-site to coordinate variations and maintenance of existing licenses.

We can work on site as well as off to coordinate variations and license maintenance in a cost effective manner:

  • PSURs
  • Type 1 A/B Variations
  • Type 2 A/B Variations
  • Coordination with Agencies

> PIL and SmPC services

Expert support Module 1 for centralized, decentralized, mutual recognition and national procedures.

PIL Services

  • Package Information Leaflet writing
  • Reformatting of PILs to QRD

SmPC services

  • SmPC writing from the BE studies
  • Creation of a core SmPC for generic applications
  • Sourcing and translating of reference product SmPCs
  • Harmonisation of SmPCs for generic applications

Medical Writing

  • Clinical overviews
  • Non-clinical overviews

> PIL, SmPC and Module 1 Translations

We translate medical documents to languages using our network of certified medical translators.

Translations for Post Approval National Phase

  • Pharma translates medical documents to all languages using our network of certified medical translators.
  • Translated into target languages by a native-speaker of that language.
  • Certified translations.
  • Translations are proofread by separate native-speakers of the target-language to ensure accuracy and quality of the translation.

Quality Control of Translated Documents

  • Pharma validates the quality of translated documents to comply with authorities by using a patients’ rights group in the target-country to ensure quality of the translation.