Local Affiliate Services
Strengthen your presence in Europe with our customizable solutions that are designed to meet your specific business size and needs. Offering complete support throughout the product’s life cycle.
Comprehensive, Localized Services Across Europe
With complex regional regulatory environments, pharmaceutical, biotechs, and medical device companies face managing multiple safety and compliance needs. We support local affiliates to ensure there is always consistency, regardless of location. Our experts streamline processes and provide local knowledge — taking you through the development, approval, launch, and license maintenance of medicinal products.
Global Reach with Local Expertise
We recognize that a genuine understanding of local regulations and requirements, whilst respecting cultural nuances and languages, alongside meeting your goals, is vital.
End-to-End Support
Our Local Affiliate services can take you from pre-submission to post-approval and manage the maintenance of your mature portfolio – supporting you across the entire product lifecycle.
Customized to Fit Your Needs
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.
ProPharma's Local Affiliate Services
provide support throughout the entire product lifecycle, ensuring that you meet local requirements and regulations.
Regulatory Sciences
We’re proud to say we are the World’s Leading Regulatory Consultancy, with decades of experience across all drug types (small molecule, biologics, oligonucleotides, and combination products) and medical device classes.
We offer flexible solutions tailored to meet your needs, with options ranging from project-based services, where our consultants work as an integrated part of your team, spanning to a fully outsourced mode, where we will take care of all of your regulatory activities
Quality & Compliance
Our full suite of Quality and Compliance (Q&C) services helps clients across the EEA with customized solutions to fit their specific needs. Our team of highly skilled Qualified Persons (QPs), Responsible Persons (RPs), and Quality Assurance (QA) officers have helped many clients obtain and maintain their WDA/MIA licenses. We also hold our own MIA license in both the UK and EU, if you would like to outsource your batch certification entirely, and offer global auditing services with over 350 vetted auditors worldwide.
Pharmacovigilance
Our full suite of customizable Pharmacovigilance (PV) services can provide you with expertise in set-up and maintenance of global and local PV systems, including Qualified Person responsible for Pharmacovigilance (QPPV) & local QPPV (LPPV) services, ICSR management, aggregate report writing, Pharmacovigilance System Master File (PSMF) and Risk Management Plan (RMP) development and maintenance, literature screenings, signal management and regulatory intelligence. Our team of qualified experts, combined with integrated technology, ensure your product meets the highest levels of compliance with both regional and global regulations.
Contact Center Support
With our scalable and 24/7 availability contact centers, we offer multilingual support from native-speaking medical professionals, so we can respond to product inquiries in a swift manner that is consistent with product labeling and regulatory guidance, but also with local evidence, culture, and communication styles.
In Europe, our experts offer support in English, French, German, Italian, Spanish, Dutch, Czech, Danish, Finnish, Greek, Hungarian, Norwegian, Polish, Portuguese, Romanian, Russian, Slovakian, Swedish, Arabic, and Turkish.
We also offer solutions to support patients, caregivers, and healthcare professionals to initiate and sustain therapies, helping them to overcome barriers and achieve better health outcomes.
Localized Strategic Support. Global Expertise.
regulatory, market access, GMP/GDP, pharmacovigilance and medical information.
Local Regulatory Support
With a team of experts boasting deep-rooted knowledge in regulatory affairs, including former EU Regulatory Agency and ex-CHMP staff, alongside seasoned industry professionals with decades of experience, we offer the comprehensive support and strategic direction needed to move your product from one regulatory hurdle to the next.
Market Authorization & Local Product Launch
- 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
Product Lifecycle Management
- 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 Materials
- 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
Market Access - Pricing & Reimbursement
- Payer landscape reviews and market assessment
- Stakeholder mapping
- Payer and KOL engagement
- Product Positioning
- Payer-relevant evidence –global value dossiers including cost-effectiveness and budget impact modelling.
- Participation in advisory boards and expert focus groups
- Policy and publication support – expert guidance for the local region
Quality and Compliance
Our Q&C team consists of over 100 highly experienced consultants that are based across the EU and UK, creating a large network of knowledge on both EU and local requirements. Our cumulative experience covers multiple types of formulations, complex supply chains, scale-up activities, technical transfer projects, aseptic/sterile manufacturing, radiopharmaceuticals, biologics, ATMPs, medical device, supply for clinical trials, and Wholesaler Dealer Authorization (WDA) application and maintenance.
MIA License Support
- Outsource your QP release through the ProPharma Group MIA
- Support with obtaining an Importation Licence for Switzerland
- Handling your product complaints.
- Auditing covering all GxP areas and CSV, providing you with a complete solution for your audit schedule
- Training
Global GxP Auditing
- We can take care of your complete audit schedule.
- GMP, GDP and GVP electronic Quality Management Systems (eQMS), gap analysis, SOP development, optimisation and management
- Regulatory inspections, mock audits, training, and remediation
- Authorithies inspection support
- Applying for API import and Brokers Licences
Product Lifecycle Management
- CLO, CDMO and 3PL licensing, selection and management
- Technical transfer
- Nitrosamine assessments
- Manufacturing scale up
- Analytical method validation and transfer
- Shipment validation
- Product and process development
- Supply chain establishment and management
Advanced Therapy Medicinal Product Support
- Gaining authorisation for GMOs handling
- Product and process development and scale up
- Analytical method development, validation, and transfer
- CLO, CDMO and 3PL licensing, selection and management
- Facility setup, qualification and authorities inspection support
Pharmacovigilance
Our pharmacovigilance (PV) experts understand the regulations in place at the European level as well as those at a country level too. We offer a range of services that can be tailored to your needs, this includes setting up of a new PV system, product launch support, benefit risk evaluation to ensure patients' safety, risk minimization activities and, PV consultancy during any types of authorization procedures.
Qualified Person Responsible for Pharmacovigilance (QPPV)
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.
Pharmacovigilance System Master File (PSMF)
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.
Role of Local Person for Pharmacovigilance (LPPV)
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.
Standard Operating Procedures and Work Instructions
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.
Contact Center Support
In addition to our scalable, 24/7 available contact centers, we offer adverse event (AE) intake and follow-up services, product complaint intake and follow-up services, patient and commercial services, and medical writing. Our experts offer support in English, French, German, Italian, Spanish, Dutch, Czech, Danish, Finnish, Greek, Hungarian, Norwegian, Polish, Portuguese, Romanian, Russian, Slovakian, Swedish, Arabic, and Turkish.
Adverse Event Intake
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.
Product Complaint Intake
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.
Patient Support
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.
Medical Writing
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.
Ready to speak with a local affiliate Expert?
With expertise across all drug types, formulations, and device risk classes, our comprehensive support covers the entire product lifecycle, from initial development until launch and product maintenance on the market.
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