Navigating Regulatory Excellence: Your dedicated partner
All Life Sciences specialises in regulatory support at country level. We are the point of contact for pharmaceutical companies and their teams in the EEA/EU, CIS and MENA regions. Our range of local regulatory affairs services covers the entire product lifecycle, helping our clients to optimise compliance with local regulations while marketing their medicines. Whether you require individual services or a comprehensive regulatory affairs outsourcing package, our offering is tailored to your individual needs.
Explore our Range of Regulatory Affairs Services:
Our experienced Medical Writing and Regulatory Affairs teams specialise in creating the documents required for the various stages of your product’s life cycle. We ensure compliance with the relevant regulations and standards and effectively demonstrate the efficacy, safety and quality of your medicinal product.
Discover our writing Services:
– Development of clinical and non-clinical overviews/summaries
– Development of overall quality summaries
– Creation of addendums to the clinical overview
– Preparation of clinical overviews/expert reports for classification changes (change from Rx to OTC)
– Development of summaries of product characteristics (SPCs) and package leaflets (PL)
– Readability tests for package leaflets (RUT) or bridging reports
– Risk management plans (1.8.2)
– eCTD publication activities using a fully validated system
– Support for new MAAs and product authorisations
Benefit from All Life Sciences’ extensive experience in preparing the submission and authorisation of new MAAs in various countries. Our team will guide you through the
regulatory authorisation process and ensure efficient product approval while saving you time and money.
Explore Our New MAA & Product Approval Services:
– EMA and National Scientific Advice Procedures
– Advice on authorisation strategy
– Dossier gap analysis
– Regulatory Dossier Writing
– eCTD publication and procedure management
– Cooperation with health authorities
– Local regulatory support at country level
– Support with product launch
Our regulatory affairs services are designed to support product launches at country level in the EU/EEA member states. Benefit from our expertise in planning market launches, anticipating challenges and ensuring compliance with EU/EEA and local regulatory requirements.
Discover our product launch support services:
– Advice on local regulatory requirements
– Exemptions for the labelling of foreign packaging
– Adaptation of educational material to local requirements
– Review and approval of promotional materials
– Review and approval of artwork, including blue box requirements
– Advice on requirements for shared packs
– Reimbursement applications
– Local Person for Pharmacovigilance (LPPV) and establishment of a local PV system
Our comprehensive regulatory affairs support includes Marketing Authorization Transfers and acquisitions of medicinal product licences. Evaluate gaps in the Dossier, strategize, and implement transfers effectively across the European Union and CIS region.
Explore Our Marketing Authorization Transfer Services:
- – Regulatory Due Diligence and Preparation of Due Diligence Reports
- – Marketing Authorization Transfer Submission Strategy (Regional and Country Level)
- – Transfer Process Management
- – Management of Variations Parallel to Transfer and Post-Approval
- – Gap Assessment of Transferred/Obtained Dossier
- – Artwork Updates After the Transfer
- – Product Reimbursement Status and Pricing Updates After the Transfer
We provide regulatory review services to ensure compliance with local regulations and pharmaceutical product marketing codes. Our experts offer constructive feedback on promotional materials for both compliance and effectiveness.
Explore Our Promotional Materials Services:
- – Regulatory Review of Promotional Materials and Non-promotional Activities
- – Creation of Abbreviated Product Information (API) Texts
- – Submission of Materials to National Regulatory Authorities
- – Translation of Promotional Materials to Local Languages
- – Set-up of Processes for Review of Promotional Materials
- – Promotional Material Archiving and Data Management
- – Consultancy on Advertising and Promotional Material Requirements
- – Training for Client Teams on Advertising and Promotional Material Requirements
Stay ahead in the ever-changing regulatory landscape with our intelligence services. Monitor regional and local regulatory changes across EU/EEA member states and CIS countries to ensure compliance and support strategic decisions.
Explore Our Regulatory Intelligence Services:
- – Local Regulatory Intelligence Monitoring
- – Regional Regulatory Intelligence Monitoring (EMA, EudraLex, CHMP, HMA, CMDh, etc.)
- – Provision of Weekly or Monthly Summary Regulatory Intelligence Reports
- – Impact Assessment of Regulatory Changes
- – Immediate Escalation of Changes Impacting Clients’ Operations or Products
- – Ad-hoc Interpretation of Regulatory Guidance Documents
At All Life Sciences, we bring a personalised touch to regulatory support, ensuring your journey through the complex regulatory landscape is seamless and tailored to your specific needs.
Our Local Pharma Regulatory Affairs Support Service offers specialised expertise in navigating regional regulatory requirements, ensuring your regulatory strategy seamlessly aligns with the local context. We provide customised support for approval processes by tailoring our services to your specific region, guiding you through local Marketing Authorization Applications (MAA) with efficiency and expertise. Our team excels in addressing submission timelines and specific documentation needs. Additionally, take advantage of our responsive eCTD Publishing services, utilising our fully validated system for Electronic Common Technical Document submissions to ensure a streamlined and compliant approval process. Choose our service for a tailored and comprehensive approach to regulatory compliance, specifically designed to meet the unique requirements of your target region.
Interested in our Services?
We are always ready to embark on exciting projects.