Freyr (UKRP Services)

Freyr is a leading global regulatory solutions provider for life sciences firms, specializing in facilitating market entry and product registrations in Japan through PMDA. They offer comprehensive services including regulatory strategy, market intelligence, and post-market surveillance.

Freyr is a premier regulatory solutions provider dedicated to supporting life sciences companies across the entire regulatory spectrum. With a significant global presence in over 120 countries, Freyr excels at enabling successful market entry, particularly in Japan, for pharmaceutical and life sciences companies. Freyr Japan is instrumental in assisting companies with product registrations under the Pharmaceuticals and Medical Devices Agency (PMDA). Their expertise covers a wide range of services, including the formulation of regulatory strategies, market intelligence gathering, in-country representation, and post-market surveillance. They also provide advanced regulatory software solutions designed to optimize the PMDA registration process. Freyr Life Sciences K.K., the Japanese subsidiary, is staffed by seasoned experts deeply familiar with Japan's regulatory landscape and pharmaceutical affairs. Leveraging an extensive international network, Freyr offers seamless support for product introductions into various overseas markets and develops tailored market entry strategies for Japan. Their team collaborates with leading manufacturers of medical devices, pharmaceuticals, OTC medicines, and cosmetics to ensure swift product approvals and timely market access. With a commitment to delivering the latest life sciences innovations worldwide, Freyr's robust global network, spanning over 25 countries, empowers them to offer end-to-end market approval support. This includes services for domestic Japanese manufacturers and assistance for entering international markets, making them a comprehensive partner for regulatory success.

About

**Who they are**
Freyr (UKRP Services) is a global regulatory solutions provider assisting life sciences firms with market entry and product registrations. They specialize in services related to the UK Responsible Person (UKRP) role.

**Expertise & scope**
* Facilitating market entry and product registrations.
* Providing comprehensive regulatory strategy and market intelligence.
* Offering post-market surveillance services.
* Appointing UK Responsible Persons.

**Reputation / proof points**
* Operates with regional delivery centers, client servicing centers, and offices in the USA, UK, EU, and India.
* Offers a free UKRP Guide for download.

Additional information

Freyr (UKRP Services) supports clients globally, with a presence indicated in the USA, UK, EU, and India. They provide resources such as a downloadable UKRP Guide, suggesting a focus on client education and preparedness for regulatory requirements. The company's structure with multiple service centers implies a capacity for broad client support and operational reach.

Key Highlights

  • Specializes in facilitating market entry and product registrations in Japan through PMDA. Source
    “Freyr is a leading global regulatory solutions provider for life sciences firms, specializing in facilitating market entry and product registrations in Japan through PMDA.”
  • Offers comprehensive services including regulatory strategy, market intelligence, and post-market surveillance. Source
    “They offer comprehensive services including regulatory strategy, market intelligence, and post-market surveillance.”
  • Provides a free UKRP Guide. Source
    “Download Freyr Free UKRP Guide”

Certifications & Trust Signals

  • Maintains offices in the USA, UK, EU, and India. Source
    “With Regional Delivery Centers, Client Servicing Centers and Offices in USA, UK, EU and India”

Buyer Snapshot

Best for
  • Life sciences companies seeking UKRP appointment
  • Firms needing regulatory strategy and market intelligence
  • Companies requiring post-market surveillance support
How engagement typically works
  • Consultative approach to regulatory challenges
  • Provision of educational resources (e.g., UKRP Guide)
Typical deliverables
  • UK Responsible Person appointment
  • Regulatory strategy development
  • Market intelligence reports
  • Post-market surveillance plans
Good to know
  • Best when requiring specialized regulatory support for life sciences products in the UK.
HQ: London, JP
Languages: English
Timezones: Europe/London
Claim status: Listed

Services & Capabilities

Find UK Responsible Person (UKRP) | Compare & Get Quotes

Jurisdictions: UK
Countries: GB
Industries: Medical devices, IVD, Healthcare
Portfolio: 26-100, 100+
Onboarding time: 3–21 days
Pricing model: Custom pricing
Starting from: GBP 4,500
Included services: UK Responsible Person (UKRP) designation, MHRA liaison and communications forwarding, Support for registration process readiness, Vigilance escalation workflows and FSCA coordination, Labeling check for UKRP identification
Supports GB: No
Supports NI: No
MHRA Support: No
Can Be Named On Label: No
MHRA Portal Support: No
Vigilance Support: No

Additional uk_rp Details

Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
Onboarding Steps
Appoint UKRP, Step-by-Step Guide
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