At PharmaRelations, we support companies in developing robust regulatory strategies to navigate the complex global landscape. Our experts help you engage with regulatory authorities, advance your clinical pipeline, and optimize the value of your assets. By providing strategic guidance throughout the development phases, we help minimize regulatory risks and accelerate your path to market.
With extensive knowledge of Nordic regulations and market dynamics, PharmaRelations is your trusted partner for navigating complex Regulatory Affairs challenges across Sweden, Denmark, Norway, and Finland. Our team brings valuable experience from the pharmaceutical industry as well as regulatory agencies, ensuring comprehensive support for your compliance and market access needs.
At PharmaRelations, we specialize in Regulatory and Quality Services for medical device software – stand-alone (SaMD), embedded or an integral part of the final medical device or IVD –ensuring compliance with international standards such as IEC 62304. Our expertise helps you navigate the complex regulatory landscape with a smart, fit-for-purpose approach that accelerates compliance and speeds up your time to market.
IEC 62304 is the internationally recognized standard for the development and maintenance of medical device software. Compliance with this standard is crucial to ensuring the safety and effectiveness of your software. Our services include:
Our commitment to regulatory excellence extends beyond consulting services. We are active members of the Swedish branch of the Technical Committee responsible for developing international standards related to medical equipment, software, and systems. This involvement ensures that we stay at the forefront of regulatory and technological advancements, providing our clients with cutting-edge insights and strategic guidance.
PV Audits and Inspections
PV Audits:
We have expertise in performing PV audits in all pharmacovigilance areas, your PV System, Local Affiliates, Partners or Service Providers.
Audit Strategy and Planning:
We support creating audit strategic and tactical Plans, and risk-based audit planning.
CSV – Computer System Validation Audits:
We have expertise in Computer System Validation audits for your Safety database system.
Mock-Inspections:
We can support Mock-inspections, i.e. setting up an inspection scenario to practice prior to a real inspection, as well as help you with all the required tasks before, during and after an inspection.
Inspection Readiness:
We can prepare and train you and your PV System to be inspection ready
The EU In Vitro Diagnostic Regulation (IVDR, EU 2017/746) introduces stricter requirements for in vitro diagnostic devices on the EU market. The regulation focuses on safety, clinical performance, and traceability to protect patients and ensure the reliability of diagnostic tools.
Our team supports you in navigating the complexities of IVDR by providing:
Whether you are transitioning from IVDD to IVDR or launching a new diagnostic device, we offer tailored solutions to streamline your regulatory journey.
Stay ahead of IVDR requirements – contact us to ensure your in vitro diagnostic device complies with the latest EU regulations.
The EU Medical Device Regulation (MDR, EU 2017/745) has set new standards for the regulatory requirements of medical devices on the EU market. The regulation imposes strict requirements on safety, traceability, and clinical evidence to ensure products are safe and effective.
We assist you with:
With experience ranging from small companies to large multinational organizations, we can guide you through every step of MDR compliance, from strategy to implementation.
Need assistance with MDR? Contact us today to ensure your product remains competitive and compliant on the EU market.
ISO 13485 is the globally recognized standard for quality management systems used in the development, manufacturing, and distribution of medical devices. This standard ensures companies have robust processes in place to meet both customer and regulatory requirements.
Our expertise in ISO 13485 can help you:
Whether you’re a start-up implementing ISO 13485 for the first time or an established company optimizing existing systems, we provide the support you need.
Learn more about our ISO 13485 services and contact us to elevate your quality management system.
Navigating the landscape of pharmaceutical compliance requires a deep understanding of international, European, and local laws, regulations, and ethical guidelines. With our team of experts from the Nordic countries, we bring knowledge and experience to your business.
We specialize in guiding companies in the Nordic region through the intricate web of ethical regulations. Whether you’re launching a new product, planning an event, or reviewing your advertising campaigns, we provide the strategic advice you need to ensure your activities are fully compliant.
Key Areas of Expertise:
We offer a wide range of services designed to support your pharmaceutical business in maintaining compliance across all marketing and promotional activities. Our flexible, ad-hoc approach means we can quickly adapt to your needs, whether you require ongoing compliance support or short-term project-based assistance. From conferences to product information meetings and materials, we provide guidance. We help ensure that your interactions with healthcare professionals and other stakeholders meet ethical standards.
We can also provide tailored training programs to equip your team with the latest knowledge on pharmaceutical marketing compliance. Whether you need a workshop on the local rules in each Nordic country or broader European regulations, we can help you stay ahead of the curve.
Compliance is not a one-size-fits-all solution, and we recognize that every business has unique needs. We tailor our services to fit your specific goals, ensuring that you receive the most relevant and effective solutions.
Here are examples of what we can offer:
When it comes to marketing compliance in the pharmaceutical industry, you need more than just a consultant, you need a trusted partner who understands both the legal landscape and the nuances of the market.
Local Expertise in a Nordic organization
With compliance experts across the Nordic countries, we offer localized knowledge, ensuring that your activities remain compliant in every market you serve.
Flexibility and Agility
We understand that compliance needs can vary from one project to the next. Whether you're seeking one-off advice or ongoing strategic support, we provide flexible, ad-hoc solutions that align with your needs and timelines.
End-to-End Compliance Support
From initial product launch to ongoing marketing efforts, we provide compliance support for all aspects of pharmaceutical marketing.
Let us guide you through the complexities of the Nordic market and help you achieve your goals with confidence.
Local Pharmacovigilance (PV) in the Nordics
We can provide local affiliate PV set-up and Local PV contact person in the Nordic countries:
such as setting up the whole Quality Management System (QMS) from start or parts of it as applicable, perform case handling, local literature review, PV intelligence, management of additional Risk Minimisation Measures, reconciliation of potential AE sources, and more.
Our colleagues in Regulatory Affairs can provide you with all necessary local regulatory support to meet the different local regulatory requirements in the different Nordic countries.
Adverse Event/Reaction Management (Human and Veterinary)
We assist with collection, validation, triage, follow-up, data management including data entry into Eudravigilance (Human/VET), MedDRA/VeDDRA coding, quality management, evaluation, submission to partners/EV/MHRA portal, reconciliation and archiving.
Risk Management Plan and Risk Minimisation Measures
We provide strategic advice, creation, medical and regulatory review, update and submission of Risk Management Plan (RMP).
We support with creation, implementation and tracking of Risk Minimization Measures (RMM).
Safety Physician, Advice
We can provide assistance with all safety physician tasks and roles all the way from medical review of regulatory documentation to global strategic safety and pharmacovigilance advisory roles, during the entire life cycle of your product.
Veterinary Surgeon
We can provide you with a veterinarian to support your company with 24/7 coverage, offering medicinal assessments of adverse events and signals, as well as addressing medicinal inquiries related to veterinary medicines.
Pharmacovigilance (PV) QMS
We perform GAP-analyses of your PV QMS.
We set-up new PV QMS tailored to your needs, develop and maintain your existing PV QMS.
We create, update and maintain of Standard Operating Procedure (SOP), Working Instruction (WI) and Templates.
Business Continuity Plans (BCP)
We can assist with creating and maintaining a Business Continuity Plan as well as creating and performing BCP tests and Set-up of BCP risk assessment scheme.
Agreements
We can create, support, maintain Pharmacovigilance Agreements (PVA), Safety Data Exchange Agreements (SDEA), Master Service Agreements (MSA), etc.
We also help you with vendor assessment, negotiation, vendor selection, set-up and maintenance of contracts, vendor management.
We develop your organization with our highly competent interim consultants. Our experts add more than just skills and competence.
Our solutions may be long term or short term, full time or part time, single or multiple consultant approach, and senior or junior competence. We can offer solutions that cover one or all Nordic countries. We prefer to create long term value and work in partnership, but also take on smaller projects, solve peak capacity problems and help you with limited projects. We proactively interview more than 1500 persons within Life Science every year and know what is happening in the industry. We finalize all assignments with sending you an NPS survey to ensure that we have met your expectations.
We are committed to supporting people and organizations to achieve their better selves
When you need competency in Medical Affairs, we are here to support you. It could be an MSL or Medical Advisor, support with medical writing, or compliance.
You may shorten the internal hiring process as our employees are already recruited by us based on a complete competency-based process, motivation to be a Consultant, and our values. Further, we work closely with our broad network of senior sub-contractors. You won't be alone during the assignment, we will stay by your side and our consultant's side with regular follow-up meetings. All our Consultant managers are experienced leaders.
In addition to that, you get support with specific tasks, you might benefit from our consultant’s network, experience from other therapeutic areas and/or companies, new dynamics in your team, or just maybe benefit from the senior Consultant Manager's experience by a second opinion/inspiration when developing your strategy or organization.
During the assignment, we follow-up continuously both with our Consultants and with you as a client to secure performance. You hire for short- or long-term depending on your needs, without need to bother about the employer responsibilities.
If you need to recruit a permanent employee, our Nordic recruitment team will be happy to support. Welcome to contact us for advice!
We outsource specialists and offer ad-hoc support to our clients. We will help you to get new pharmaceuticals, products, methods, and devices to the market faster!
We develop your organization with our highly competent consultants. Our experts add more than just skills and competence, they add experience and know-how from the industry and many different companies. We work across all Nordic countries.
Our main goal is to work closely together with you and solve your challenges in a flexible manner.
We offer you flexible solutions and take on both smaller projects involving only one expert and a few hours as well as and bigger projects involving several competences. We solve peak capacity challenges and help you with limited projects.
We can support you with:
We provide end-to-end regulatory support, ensuring compliance, efficiency and market access across the Nordic region and beyond. With deep expertise in regulatory frameworks, we streamline processes, manage interactions with authorities, and facilitate product approvals and lifecycle management. Our multilingual capabilities and strategic insights help clients navigate complex regulatory landscapes with confidence, enabling successful product launches, expansions, and ongoing compliance.
EU&UK QPPV/Deputy QPPV
The roles of the EU QPPV and UK QPPV are required in the respective regulations from EMA and MHRA. Our experienced personnel can perform these roles for both human and veterinary medicines, including medically qualified backup personnel (physician, veterinarian) available as legally required.
We also provide the role of a Deputy EU QPPV and Deputy UK QPPV for both human and veterinary medicines.
We also provide QPPV EudraVigilance registration support.
Safety Physician, Advice
We can provide assistance with all safety physician tasks and roles all the way from medical review of regulatory documentation to global strategic safety and pharmacovigilance advisory roles, during the entire life cycle of your product.
Veterinary Surgeon
We can provide you with a veterinarian to support your company with 24/7 coverage, offering medicinal assessments of adverse events and signals, as well as addressing medicinal inquiries related to veterinary medicines.
Pharmacovigilance (PV) QMS
We perform GAP-analyses of your PV QMS.
We set-up new PV QMS tailored to your needs, develop and maintain your existing PV QMS.
We create, update and maintain of Standard Operating Procedure (SOP), Working Instruction (WI) and Templates.
Pharmacovigilance System Master File (PSMF)
Creation, update and maintenance of the PSMF and Summary of Pharmacovigilance System (SPS).
Risk Management Plan and Risk Minimisation Measures
We provide strategic advice, creation, medical and regulatory review, update and submission of Risk Management Plan (RMP).
We support with creation, implementation and tracking of Risk Minimization Measures (RMM).
Safety Database
We can help you implement, validate and maintain your Safety Database including performing periodic reviews and assessments .
We support in creating User Requirement Specification (URS), Risk Impact Assessments, Validation Plans, Test Approach, Test Reports, Validation Reports, System List/Registers, necessary support and maintenance procedures and forms (governing user access, security, change control, validation, problems and incident, back-up and restore, business continuity, periodic reviews etc).
PV in geographical expansion /Market Acquisitions/DD (due diligence)
We support and lead PV teams in Due Diligence/Market Acquisitions/Geographical expansion projects going into new markets or regions globally.
Improvement projects
We have experience of driving different PV improvement and transformation projects both globally and locally, to increase efficiency and quality while still having a pragmatic and lean approach.
Business Continuity Plans (BCP)
We can assist with creating and maintaining a Business Continuity Plan as well as creating and performing BCP tests and Set-up of BCP risk assessment scheme.
Agreements
We can create, support, maintain Pharmacovigilance Agreements (PVA), Safety Data Exchange Agreements (SDEA), Master Service Agreements (MSA), etc.
We also help you with vendor assessment, negotiation, vendor selection, set-up and maintenance of contracts, vendor management.
We part from the idea that to use data, we need to first ask the right questions, then we use visualization and reports to ease the use of insights
- Project managers
Life science is always evolving when it comes to products and devices but has a hard time keeping up with others when commercial requires technology to be implemented.
PharmaRelations offers a unique perspective on technological solutions that have been discussed with other expert areas within our organization such as compliance, regulatory and medical.
Some of our services:
Our team of experts can guide you to find the most suitable solution for your organization.
At PharmaRelations, we specialize in providing high-quality Quality Assurance (QA) consulting services tailored to the unique needs of the pharmaceutical industry. Whether you're preparing for a regulatory inspection, implementing a GMP-compliant quality management system, or managing deviations and CAPAs, our experienced QA consultants are here to support your team every step of the way.
Our consultants bring deep expertise from several roles in the pharmaceutical sector and regulatory authorities. This means we offer not just theoretical knowledge, but practical, inspection-ready solutions that ensure compliance with GMP, GDP, GLP, and GCP requirements.
We deliver flexible QA solutions — from Qualified Persons (QPs) working full-time on-site to part-time remote support from our in-house consultants. We help you build, strengthen, and maintain robust quality systems that meet regulatory expectations and support business growth.
