seQure’s Regulatory Affairs experts can provide support through all stages of drug development. We can help clients put together a regulatory strategy document to determine your pathway forward. Plans can be validated by preparing briefing documents and support through Regulatory Agency meetings. We can manage development programs from the very early stages of development through to submission of a Marketing Authorisation Application.

Submission of Marketing Authorisation Applications

Marketing Authorization Applications are developed and coordinated by Regulatory Experts and supported by CMC, non-clinical, clinical and medical writing experts on an as needed basis.

Consultancies and Services are provided for:

    • Preparation and Management of Applications for Centralised Authorisation Procedures (CAP), Mutual Recognition (MRP), Decentralised procedures (DCP) and National Procedures (NAP)
    • Variation, planning, submission and Management
    • High quality translations of the Summaries of Product Characteristics, Labelling and Patient Leaflet to the local language
    • Due Diligence
    • Medical and Regulatory writing ( e.g. Protocols, Investigator’s Brochure, Investigational Medicinal Products Dossiers, CMC, Non Clinical and Clinical Overviews and Summaries, ISE and ISS).
    • In-house training, mentoring and departmental reviews
    • Regulatory compliance
    • Clinical trial applications
    • Orphan drug designations
    • Paediatric investigational plans
    • Regulatory strategy
    • Scientific advice
    • International via a network of local consultants

Our international regulatory affairs professionals are highly experienced in the coordination, preparation and submissions to any Regulatory Authority.

Submission of Clinical Trial Applications

For clinical trials, we are able to offer advice and can prepare:

  • Investigator Brochures (IBs)
  • Investigational Medicinal Product Dossier (IMPDs)
  • All other elements of clinical trial submissions

Highly experienced Regulatory Affairs professionals coordinate a network of local experts to submit local clinical trial and ethics committee applications to minimize issues related to local nuances and language barriers and maximize efficiency.