Global Regulatory Intelligence for Pharmacovigilance
Need a better way to manage regulatory intelligence?
There are many challenges faced today when trying to run regulatory compliance for a global organization.
Being able to accurately track new and changing regulations is a demanding task, even with substantial resources and traditional data sources. Some countries have clear regulations and notifications of changes in place, whereas many other countries do not, and determining what constitutes compliance can be very difficult. There is also the number of languages to deal with and many organizations rely on local affiliates to help. But what if you don’t have a local affiliate?
Transforming regulatory documents into actionable intelligence can also be tricky. Document text can often be difficult to interpret and being able to translate that into implementable rules for technical teams is a significant obstacle. Industry examples show regulations can take over six months to be integrated into safety databases successfully.
Finally, verification and confirming global implementation of requirements can be challenging. How do you know you’ve got it right?
How much does it cost?
Take advantage of our introductory pricing which is simple and straightforward
Regulatory Intelligence Service
Includes the regulatory intelligence services, including monthly updates of all regulatory documents and associated rules for ICSRs, Devices, QPPV requirements, PSURs, RMPs etc. and invitations to regulatory intelligence events and industry collaboration.
EUR 2,500 per Month
HALOPV Subscription
Provides a quick and easy way to access your requirements. HALOPV is a cloud-based, multi-tenant solution that provides a wide range of services, one of which is requirements intelligence. A medium level HALOPV tenant will provide 4 user accounts to access the tool and the requirements within.
EUR 1,500 per Month
For pricing in non-EUR currencies please contact us at hello@insife.com
Take GRIP for a test drive today, no strings attached!
As part of our exclusive offer, we're thrilled to invite you to experience the power of GRIP with a complimentary one-month free trial. This is your chance to explore the extent of our services and see the difference first hand. To activate your free trial and start your journey to elevating your pharmacovigilance operations, simply email us at hello@insife.com.
* Please note, Insife reserves the right to approve or deny membership applications without further explanation. We are committed to protecting your privacy; your personal information will never be sold or passed on, in accordance with Insife's Data Privacy Policy
FAQs
GRIP is a one-of-a-kind subscription service for PV regulatory intelligence, with game changing technology, access to pre-analysed regulatory information for 160+ countries and peer-to-peer networking.
GRIP members get exclusive access to our requirements intelligence module of HALOPV, our GxP validated software, containing the latest regulatory source documents from over 160+ countries, pre-analysed by our experienced team of PV SMEs, into clear ‘reporting rules’ for ICSR and device reporting, as well as QPPV and Local QPPV information. Other workflows such as Aggregate reporting, Risk Management Plans and PSMFs are coming soon. GRIP membership also comes with a service, giving you frequent updates to changing regulations and a consolidated monthly report. Lastly, GRIP also comes with networking opportunities via webinars and round tables.
Our team of experienced regulatory intelligence professionals with a background in PV utilise an automated web-scraper tool with AI functionality, which screens web pages and documents for changes to regulatory intelligence information. Any updates found undergo a translation step into English (if needed), analysis and peer-to-peer QC. Results of our weekly and monthly screening are clearly documented.
We scan web pages containing regulatory information for over 160 countries worldwide, plus umbrella organisations such as CIOMS, CMDh, EC, ICH, IMDRF, MedDRA, and UMC.
We conduct weekly and monthly screening, and make updates to our system in real-time, as soon as the updates are found. The frequency of update to our GRIP members’ instance of HALO is at our members’ discretion and can be anything from daily, to weekly or monthly.
You will be able to query, filter and download reports directly from the system with specific details. These reports are available in a range of formats including csv and pdf.
For technical queries, our support team are available 5 days a week. For any queries related to regulations, our GRIP team will reach out to our contacts in global regulatory agencies to try to get the answers needed in a timely manner.
GRIP isn’t just a data dump of complex regulatory documents. Our team of experienced PV SMEs have already reviewed, translated and interpreted the reporting requirements for you, creating records with all the key information that you need. Coupled with our HALOPV submissions tool, that takes care of auto-scheduling of ICSRs to the correct authorities – as these records become reporting rules. You will still have access to all the source documentation directly within the records, and you’ll be able to download customised reports tailored to your needs. If anything in the regulations isn’t clear, we’ll reach out to the local Authorities for you. And finally, the other unique feature of GRIP is our community. Share thoughts, ideas, interpretations and questions with your peers via our GRIP events.
GRIP is priced separately for the regulatory intelligence service and the subscription to HALOPV technology.
The service costs 2,500 EUR / 2,800 USD per month
The HALOPV subscription costs 1,500 EUR / 1,700 USD per month
A full GRIP membership costs 4,000 EUR / 4,500 USD per month
To organise a demo or to get in touch with a member of the team, please contact hello@insife.com
Countries included in the service
Albania
Algeria
Andorra
Angola
Anguilla
Antigua & Barbuda
Argentina
Armenia
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Bermuda
Bhutan
Bolivia
Bosnia & Herzegovina
Botswana
Ecuador
Egypt
El Salvador
Estonia
Ethiopia
Finland
France
Gabon
Georgia
Germany
Ghana
Greece
Grenada
Guatemala
Guinea
Guyana
Haiti
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Israel
Italy
Jamaica
Japan
Jordan
Kazakhstan
Kenya
Korea (Republic of)
Kosovo
Kuwait
Kyrgyzstan
Latvia
Lebanon
Lesotho
Libya
Liechtenstein
Lithuania
Luxembourg
Macau
Macedonia
Madagascar
Malawi
Malaysia
Mali
Malta
Mauritania
Mauritius
Mexico
Moldova (Moldavia)
Mongolia
Montenegro
Montserrat
Morocco
Myanmar
Namibia
Nepal
Netherlands
New Zealand
Nicaragua
Niger
Nigeria
Norway
Oman
Pakistan
Palestinian Territory
Panama
Paraguay
Peru
Phillipines
Poland
Portugal
Puerto Rico
Qatar
Romania
Russia
Rwanda
Saint Kitts & Nevis
Saint Lucia
Saint Vincent & Grenadines
Saudi Arabia
Senegal
Serbia
Sierra Leone
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Sudan
Swaziland
Sweden
Switzerland
Syria
Taiwan
Tajikistan
Tanzania
Thailand
Togo
Trinadad & Tobago
Tunisia
Turkey
Turkmenistan
Brazil
Brunei
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cayman
Chile
China
Colombia
Congo
Costa Rica
Cote D'Ivoire/Ivory Coast
Croatia
Cuba
Cyprus
Czech Republic
Denmark
Dominica
Dominican Republic
Turks & Caicos
Uganda
Ukraine
United Arab Emirates
United Kingdom
Uruguay
USA
Uzbekistan
Venezuela
Vietnam
Zimbabwe
An extensive compilation of global PV (Pharmacovigilance) regulatory documents and associated reporting rules
Documents are provided in source language with translated English version. The accompanying expedited reporting rules have been collected and analysed by Insife’s pharmacovigilance experts. The team consistently assesses and interprets changes in legislation and finds the relevant new information for GRIP members, taking that time consuming, but vital, job out of your hands. The service currently covers 160+ countries.
Access to our game changing technology platform HALOPV
Intelligence data are presented to you in HALOPV, providing a means for maintaining the base requirements and then being able to extend and tailor them for your own specific commitments and waivers. If you already have a subscription for HALOPV or HALOPV Enterprise Requirements Intelligence module, you are all set from a technology point of view… we will just load the requirements into your environment.
The GRIP Community
Benefit from the GRIP community via networking events and discussion forums with regulatory intelligence peers, both from Insife and other companies. These activities allow for collaboration and sharing of opinions and experiences from the broader GRIP membership. They are also an opportunity for “Crowdsourcing”, which ensures higher quality of the regulatory intelligence records you are provided as part of GRIP.
By utilizing the GRIP service, you can simplify the safety reporting process by eliminating common points of failure such as manual review of data, human error and lack of technology. Having a reliable service in place that provides regular updates will help increase your compliance with worldwide regulatory standards and also decrease your dependence on finding information from multiple sources. Overall, having a centralized regulatory intelligence service, will reduce a lot of manual effort that can be utilized in other important areas of your business.