Scandinavian Regulatory Services

What Scandinavian Regulatory Services does

Scandinavian Regulatory Services (SRS) is a privately held, founder-owned regulatory affairs and quality assurance consultancy headquartered in Danderyd, Sweden, founded in 1992 by Lars Janson — a former Swedish MPA practitioner — and currently led by Managing Director Anki Jareman, who assumed the role around 2012 after a corporate division of the original entity. The firm provides expert regulatory and quality support to pharmaceutical, medical device, combination product, cosmetics, and food supplement companies across the Nordic countries, the wider EU/EEA, and select international markets including the US, China, Latin America, the Middle East, and Africa. Core services include dossier compilation and eCTD submissions, marketing authorization applications and life cycle management (centralized, MRP, DCP, and RUP procedures), CE-marking under MDR/IVDR, ISO 13485 and 21 CFR 820 quality system implementation, Qualified Person (QP) and Responsible Person (RP) services, GDP/GMP compliance and auditing, local Nordic pharmacovigilance, and regulatory strategy — delivered either as project-based consulting or as a fully outsourced QA/RA function for clients.

The firm's ~23-person team is unusually senior, consisting almost entirely of directors and principal experts with 15-30+ years of individual experience, including former regulatory assessors from the Swedish MPA and TLV. Technology is human-expert-driven: no software platform, API, or AI/ML capability is disclosed; the core "technology" is institutional regulatory knowledge accumulated across 800+ cumulative clients and hundreds of product authorizations, including over 60 wholesale distribution authorizations and DCP procedures spanning up to 17 countries. SRS operates a B2B, sales-led go-to-market with quote-based, project-priced professional services delivered through direct client engagement, supplemented by industry network channels — SwedenBIO, EUDRACON, and PharmaPriceInternational (PPI), through which SRS provides Nordic market access services within a global pricing/reimbursement network.

Name

Scandinavian Regulatory Services

Legal name

Scandinavian Regulatory Services

Website

https://srs.se

Company type

Private

Founded year

1992

Operating status

Operating

Headcount range

1–10 employees

Short description

Scandinavian Regulatory Services is a Sweden-based, founder-owned regulatory affairs and quality assurance consultancy founded in 1992, serving pharmaceutical, medical device, combination product, cosmetics, and food supplement companies across the Nordics, EU, and select international markets via senior expert consulting.

Ownership category

akta.pro rank

Product category

Regulatory Affairs and Quality Assurance Consulting

NAICS

Management, Scientific, and Technical Consulting Services (5416)

SIC

Services-Management Services (8741)

akta.pro primary industry

Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC)

akta.pro secondary industries

Product, Safety & Quality Compliance (incl. Regulatory Affairs) (BPAHAFAM), Regulatory Consulting & Compliance Program Management (FDA/USDA/EFSA) (AFALADAC)

Keywords

• Regulatory affairs consulting
• Pharmaceutical compliance services
• Medical device regulations
• Quality assurance consulting
• Pharmacovigilance services

Headquarters

HQ city

Danderyd

HQ country

Sweden

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Regulatory Affairs Consulting: Professional consulting services for regulatory affairs including dossier compilation, marketing authorization applications, life cycle management, regulatory strategies, and authority interactions. Provided as project-based engagements or ongoing support.
2. Quality Assurance Services: QA support including Qualified Person (QP) and Responsible Person (RP) services, quality management system setup and maintenance, GDP certification support, and inspection preparation. Can be provided as interim/temporary support or continuous partnership.
3. Pharmacovigilance Services: Local Nordic pharmacovigilance services including case reporting, local PV office management, complaints handling, medical information, and post-market surveillance.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Scandinavian Regulatory Services provides expert regulatory affairs and quality assurance consulting to pharmaceutical, medical device, combination product, cosmetics, and food supplement companies. Services span dossier compilation and eCTD submissions, marketing authorization applications, life cycle management, EU and US submissions, QP/RP services, GMP/GDP quality systems, pharmacovigilance, due diligence, and authority interactions, delivered either as project-based engagements or as the full outsourced QA/RA function for a client.

Product overview

Scandinavian Regulatory Services (SRS) is a regulatory affairs and quality assurance consulting services company, not a software product company. SRS operates as a single unified service offering that provides expert regulatory and quality support across four distinct service areas: Pharmaceuticals (regulatory affairs, QA, pharmacovigilance, GDP/GMP support), Medical Devices (MDR/IVDR compliance, CE-marking, QMS), Combination Products (drug-device regulatory strategies and quality systems), and Cosmetics & Food Supplements (safety assessment, labeling, compliance). Services are delivered by expert consultants who provide flexible solutions tailored to client needs, either as support to existing teams or as the complete QA/RA function for companies.

Differentiator

Problem solved

Functional benefit

Products and services

• Pharmaceuticals Regulatory Affairs and Quality Services Comprehensive regulatory affairs and quality assurance services for pharmaceutical products, including dossier compilation, eCTD submissions, marketing authorization applications, life cycle management, GMP/GDP support, QP/RP services, and local Nordic pharmacovigilance. Services can act as support to an existing team or as the full outsourced QA/RA function for a company.
• Medical Devices Regulatory Affairs and Quality Services Quality and regulatory support for medical devices and IVDs across the lifecycle, covering device development, CE marking under MDR/IVDR, ISO 13485 and 21 CFR 820 quality system development, risk management, notified body interactions, and international registrations including FDA.
• Combination Products Regulatory Support Quality and regulatory support for drug-device combination products, covering classification, strategies, technical documentation, marketing authorization applications, quality management system establishment, notified body interactions, and post-marketing activities for products that span both pharmaceutical and medical device frameworks.
• Cosmetics and Food Supplements Regulatory Services Regulatory and quality support for cosmetics, nutrition, and food supplements, including safety assessment, Cosmetic Product Safety Reports (CPSR), product information files, labeling compliance, CPNP notification, Swedish and Nordic legislation compliance, and nutrition and health claim strategies.

Quantifiable outcome

• Over 800 clients served globally
• +3 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Three partnerships are on record, tiered core and supporting.

• PharmaPriceInternational (PPI)coreStrategic or Co-development PartnerSRS is responsible for market access for the Nordic countries within the international network PharmaPriceInternational (PPI). Through the PPI network, SRS has access to pricing and reimbursement experts in major geographies worldwide, enabling comprehensive market access services for clients.
• SwedenBIOsupportingGTM or Marketing PartnerSwedenBIO is the Swedish Life Science Industry Organization. SRS's partnership with SwedenBIO provides industry networking, visibility within the Nordic life sciences community, and connection to the broader Swedish biotech and pharmaceutical ecosystem.
• EUDRACONsupportingStrategic or Co-development PartnerEUDRACON is a European regulatory affairs network. SRS collaborates with EUDRACON to provide coordinated regulatory services across European markets, leveraging shared expertise and resources within the network.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• PharmaLex: Global regulatory affairs, pharmacovigilance, and quality consulting firm (now part of Cencora). Direct competitor offering the same pharma regulatory and quality services as SRS, but at much larger scale across multiple geographies.
• RApport Global Services: Specialist regulatory affairs consultancy serving pharmaceutical and medical device companies. Highly comparable in scope and scale to SRS, with overlapping focus on EU submissions, MAAs, and lifecycle management.
• NDA Group: European regulatory and HTA consulting firm with strong pharma and medical device expertise. Comparable to SRS in mid-market positioning, regulatory strategy depth, and EU-centric service offering.
• ProPharma Group: Global regulatory compliance, quality, and pharmacovigilance consultancy. Comparable to SRS in regulatory affairs services for pharma and medical devices, though with broader geographic footprint.
• Diamond Pharma Services: Regulatory affairs and pharmacovigilance consultancy for pharma clients. Direct peer with similar mid-market focus on EU regulatory strategy, submissions, and lifecycle management.
• Voisin Consulting Life Sciences: Regulatory affairs and clinical development consultancy with strong medical device and combination product expertise. Comparable to SRS in cross-vertical regulatory support and EU/ US focus.
• Xendo: European pharmaceutical and medical device regulatory and quality consultancy. Comparable to SRS in offering integrated RA/QA services to mid-sized pharma and medtech companies across Europe.

Broad incumbents

• Parexel International: One of the largest global CROs with a substantial regulatory services division. Overlaps with SRS in pharma regulatory consulting but as part of a much broader clinical and commercialization portfolio.
• ICON plc: Global CRO with significant regulatory and pharmacovigilance capabilities serving pharma and medical device clients. Competes with SRS in regulatory services but at much larger scale and as part of full-service offering.

Emerging players

• NAMSA: Medical device-focused regulatory and quality consulting organization. Partial overlap with SRS's medical device practice, with similar mid-market client profile but deeper device specialization.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Scandinavian Regulatory Services