Regulatory Affairs
seQure is the business unit of Arithmos, related to Quality Compliance and Consulting Services.
Our Regulatory Affairs experts can support you through all stages of your drug development.
We can help to 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 the 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.
Our international regulatory affairs professionals are highly experienced in the coordination, preparation and submissions to any Regulatory Authority.
We provide Consultancy and Services 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-qualityty 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
Submission of Clinical Trial Applications
Highly experienced Regulatory Affairs professionals coordinate a network of local experts to submit local clinical trials and ethics committee applications to minimize issues related to local nuances and language barriers and maximize efficiency.
For clinical trials, we give advisory and prepare:
- Investigator Brochures (IBs)
- Investigational Medicinal Product Dossier (IMPDs)
- All other elements of clinical trial submissions
