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 for Japan through PMDA and offer comprehensive regulatory support.

**Expertise & scope**
* Facilitating market entry and product registrations
* Regulatory strategy development
* Market intelligence gathering
* Post-market surveillance
* UK Responsible Person (UKRP) appointment services

**Reputation / proof points**
* Offices and service centers in USA, UK, EU, and India.

Additional information

Freyr (UKRP Services) provides a guide for UK Responsible Person (UKRP) services, indicating a structured approach to compliance. Their global presence, with centers in the USA, UK, EU, and India, suggests a capacity to support international clients. The company emphasizes a comprehensive approach, covering regulatory strategy, market intelligence, and post-market surveillance, which are critical components for life sciences firms navigating complex regulatory landscapes.

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.”
  • Has regional delivery centers, client servicing centers, and offices in the USA, UK, EU, and India. Source
    “With Regional Delivery Centers, Client Servicing Centers and Offices in USA, UK, EU and India”

Certifications & Trust Signals

  • Established presence with offices in multiple global regions. Source
    “With Regional Delivery Centers, Client Servicing Centers and Offices in USA, UK, EU and India”

Buyer Snapshot

Best for
  • Life sciences firms seeking market entry and product registration support.
  • Companies requiring UK Responsible Person (UKRP) services.
How engagement typically works
  • Consultative approach to regulatory strategy.
  • Comprehensive service offering from market entry to post-market surveillance.
Typical deliverables
  • Regulatory strategy documentation.
  • Market intelligence reports.
  • Post-market surveillance plans.
  • UKRP appointment.
Good to know
  • Best when requiring specialized regulatory expertise for life sciences.
HQ: London, JP
Languages: English
Timezones: Europe/London
Status: listed

Services & Capabilities

Best 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
Offers a step-by-step guide for UKRP appointment.
Request quotes
Cruxi - Regulatory Compliance Services