Local Affiliate Services

We recognize that a genuine understanding of local regulations and requirements, whilst respecting cultural nuances and languages, alongside meeting your goals, is vital.

Our Local Affiliate services can take you from pre-submission to post-approval and manage the maintenance and pricing and reimbursement of your mature portfolio – supporting you across the entire product lifecycle. 

Our solutions and strategies can be tailored to fit your needs, with the ability to scale up when needed. Our experts can act as an extension to your departments, or you can outsource all responsibilities.   

• Europe: Centralized, MRP, DCP and National US: NDA, BLA and ANDA
• GAP analysis and submission strategy
• Dossier compilation/medical writing
• Pre-submission meetings
• MAH-transfer projects
• Publishing (eCTD/CESP) 
• Product launch checklist 
• Review of artwork for printing
• Registration in local regulatory databases
• Local country regulatory advice

• Regulatory advice
• Health authority liaison services (communication)
• Publishing (eCTD)
• Regulatory submissions (e.g., variation applications, line extensions, and renewals)
• Support for post-authorization commitments
• Product information (PI) updates/translations 
• Artwork reviews
• Management of catalogue texts and local regulatory databases 

• Regulatory review of promotional and non-promotional materials and activities in accordance with the respective ethical codes in the local country
• Creation and update of Abbreviated Product Information (API) texts
• Support in setting up a routine for local review of promotional materials in the local country
• Advice on general questions regarding the local ethical codes 

• Payer landscape reviews, product positioning, and market assessment 
• Stakeholder mapping and payer and KOL engagement
• Product Positioning
• Development of global value dossiers and local pricing and reimbursement applications
• Support with evidence synthesis including health economic modelling
• Local market access policy review and strategic advice support – expert guidance for the local region

• Achieve and maintain high-quality products by augmenting your local QA team or managing your entire QA requirements
• Handling your product complaints
• Electronic Quality Management Systems (eQMS), gap analysis, SOP development, optimization, and management  
• Training
  

• Apply for Wholesaler Dealer Authorization (WDA) and maintain your existing WDA with the support of our Responsible Persons, acting as contractors named on your WDA in various EU countries
• For the UK, we can provide both Responsible Persons and Responsible Persons import (RPi)

• Outsource your QP release through the ProPharma Group MIA
• Support with obtaining an Importation Licence for Switzerland
• Auditing covering all GxP areas, providing you with a complete solution for your audit schedule
• Regulatory inspections support, mock audits, and remediation

• CLO, CDMO and 3PL selection and management
• Technical transfer
• Manufacturing scale up
• Analytical method validation and transfer
• Shipment validation
• Supply chain establishment and management
• Gaining authorisation for GMOs handling
• Facility setup, qualification

Every marketing authorization holder (MAH) in Europe has to establish a PV system for the fulfilment of PV tasks for its products. When setting up a PV system in Europe, the MAH must appoint an EU/UK QPPV to establish and maintain the MAH’s PV system. We can provide you with qualified and experienced QPPVs.

A PV system monitors the safety of authorized medicinal products. The EU PSMF is a legally required document that provides a comprehensive description of the MAH’s PV system. Our QPPV office team has extensive experience working with many different PV systems and annually are responsible for the creation and maintenance of 50 client PSMFs.

Many European countries legally require a LPPV at a country level who report to the EU QPPV. Although the requirements and responsibilities of an EU QPPV are specified in EU legislation, LPPVs are subject to their own national legislation. We can provide you with a LPPV to ensure your compliance with the regulations in place.

Our experts can write your quality system documents, like standard operating procedures (SOPs) and work instructions (WIs), ensuring you meet European regulations and requirements and remain compliant.

Our skilled specialists follow processes and guidelines to obtain timely, accurate, and comprehensive AE information. Our AE collection forms can be customized for your needs in our fully validated database and our specialists are experienced with various client databases and AE forms.

Our MI team is trained on Product Quality Complaint (PQC) intake. We ensure that every PQC is collected for patients’ safety, customer journey, and compliance at every contact center exchange and sent to the designated quality department.

We offer extensive patient support and commercial services to support our clients' customers and patients. Our diverse team of global contact centers and certified field partners support patients and healthcare professionals in obtaining, understanding, and adhering to therapies for a well-rounded customer journey.

Our team of writers, editors, and quality reviewers knows what it takes to produce clear, concise text for your clinical, scientific, and regulatory needs. This includes document creation, content management, response document maintenance, translation, and more.