Regulatory Intelligence

Make regulatory intelligence drive regulatory affairs business processes

REGULATORY INTELLIGENCE

Over the last decade, regulatory agencies worldwide have gradually developed regulations and laws to regulate drug development processes in a consistent manner. As more counties adopt these practices there is a large set of rules and regulations that are both global and local in a constant state of evolution and change. Organizations currently do not have a centralized process to manage tracking, maintaining and distribution of the various rules and regulations. The current processes utilize a combination of tools, external system and websites to collate the information. This process is manual, error-prone involving repetitive work with a high degree of risk and non-compliance. As the scale of operations grow, the potential for delays, errors, or loss of communication of critical information increases.

Quartica’s solution can help organizations manage global and local regulations worldwide in a centralized collaborative system. Organizations can manage up-to date information with history of changes and ensure all stakeholders within the company have access to the latest information. The system also provides country based roles access allowing individual countries to update and publish their regulations set.

Benefits

Manage global mandates, regulations and internal organizational policies and procedures

Communicate analysis of international, regional and national safety regulatory reporting requirements .

Manage summary and position papers including responses to regulatory documents.

Manage internal assessment, review and approval of updates to regulations.

Ready to automate your Regulatory Intelligence management process?

Key Features

One stop shop to manage worldwide mandates, regulations and guidelines.
Support to track internal company policies and guidelines.
Interactive map based view color coded based on strength of regulation in the country.

Re-use meta-data, fields and data across globally.
Version history to track all changes and effective documents.
21 CFR Compliant with built in audit trial, security and confidentiality protocols.

PLEASE READ THIS TERMS OF USE AGREEMENT (THE “TERMS OF USE”) CAREFULLY. The terms and conditions provided below are applicable to the Quartica website located at Quartica.com; all e-mail newsletters published or distributed by Quartica, Inc.; all apps published by Quartica; and all other interactive features and communications provided by Quartica (collectively, the “Services”), however accessed and/or used, that are operated by us, made available by us, or produced and maintained by Quartica, Inc. (collectively “Quartica” or “we”, “us”, or “our”) (“Website”).

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1. Website Access License; Update. Quartica grants you a limited, revocable, non-exclusive, non-transferable license to access and make use of the Website, the Services or the Content (defined in Section 2). This license does not include any resale or commercial use of the Website, the Services or the Content; any collection and use of any product listings, descriptions, or prices; any derivative use of the Website, the Services or the Content; any downloading or copying of account information for the benefit of another merchant; or any use of data mining, robots, or similar data gathering and extraction tools. The Website and/or any portion of the Website, or the Services may not be reproduced, sold, resold, visited or otherwise exploited for any commercial purpose without Quartica’s express written consent. You will not use any meta tags or any other “hidden text” utilizing our name or trademarks without our express written consent. Additionally, you agree that you will not: (i) take any action that imposes, or may impose in our sole discretion an unreasonable or disproportionately large load on our infrastructure; (ii) interfere or attempt to interfere with the proper working of the Website, the Services or any activities conducted as part of the Website or Services; or (iii) bypass any measures we may use to prevent or restrict access to the Website or Services. Any unauthorized use automatically terminates the permissions and/or licenses granted by us to you. You understand that the Quartica Website, Services and Content are evolving. As a result, Quartica may require you to accept updates to the Website, Services and Content that you have installed on your computer or mobile device. You acknowledge and agree that Quartica may update the Website, Services and Content with or without notifying you. You may need to update third-party software from time to time in order to use the Website, Services and Content.
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3. Trademarks/No Endorsement. All trademarks, service marks and trade names of Quartica used herein (including but not limited to: Quartica name, Quartica corporate logo, the Website name, the Website design, and any logos) (collectively “Marks”) are trademarks or registered trademarks of Quartica or its affiliates, partners, vendors or licensors. You may not use, copy, reproduce, republish, upload, post, transmit, distribute, or modify Quartica trademarks in any way, including in advertising or publicity pertaining to distribution of materials on the Website or in the Services, without Quartica’s prior written consent. You shall not use Quartica’s name or any language, pictures or symbols which could, in Quartica’s judgment, imply Quartica’s endorsement in any (i) written or oral advertising or presentation, or (ii) brochure, newsletter, book, or other written material of whatever nature, without prior written consent.
4. Solicited Submission Policy. Where Quartica has specifically invited or requested submissions or comments, Quartica encourages you to submit content to Quartica that they have created for consideration in connection with the Website (“User Submissions”). User Submissions remains the intellectual property of the individual user that submitted it. By posting content on our Website, you expressly grant Quartica a non-exclusive, perpetual, irrevocable, royalty-free, fully paid-up worldwide, fully sub-licensable right to use, reproduce, modify, adapt, publish, translate, create derivative works from, distribute, transmit, perform and display such content and your name, voice, and/or likeness as contained in your User Submission, in whole or in part, and in any form throughout the world in any media or technology, whether now known or hereafter discovered, including all promotion, advertising, marketing, merchandising, publicity and any other ancillary uses thereof, and including the unfettered right to sublicense such rights, in perpetuity throughout the universe. You acknowledge that Quartica has no obligation to pre-screen Content from You or other users, although Quartica reserves the right in its sole discretion to pre-screen, refuse or remove any Content. By entering into these Terms of Service, you hereby provide your irrevocable consent to such monitoring. In the event that Quartica pre-screens, refuses or removes any Content, you acknowledge that Quartica will do so for Quartica’s benefit, not yours. Without limiting the foregoing, Quartica shall have the right to remove any Content that violates these Terms of Service or is otherwise objectionable. Any such User Submissions are deemed non-confidential and Quartica shall be under no obligation to maintain the confidentiality of any information, in whatever form, contained in any User Submission. You agree that your submission of any ideas, suggestions, documents, and/or proposals to Quartica through its suggestion, feedback, wiki, forum or similar pages (“Feedback”) is at your own risk and that Quartica has no obligations (including without limitation obligations of confidentiality) with respect to such Feedback. You represent and warrant that you have all rights necessary to submit the Feedback. You hereby grant to Quartica a fully paid, royalty-free, perpetual, irrevocable, worldwide, non-exclusive, and fully sublicensable right and license to use, reproduce, perform, display, distribute, adapt, modify, re-format, create derivative works of, and otherwise commercially or non-commercially exploit in any manner, any and all Feedback, and to sublicense the foregoing rights, in connection with the operation and maintenance of the Website and Services.
5. Advertising Rights. Quartica reserves the right to sell, license and/or display any advertising, attribution, links, promotional and/or distribution rights in connection with your creative submission, and Quartica and its licensors or affiliates will be entitled to retain any and all revenue generated from any sales or licenses of such advertising, attribution, links, or promotional or distribution rights. Nothing in these additional terms obligates or may be deemed to obligate Quartica to sell, license or offer to sell or license any advertising, promotion or distribution rights.
6. Third Party Links. From time to time, the Website may contain links to websites that are not owned, operated or controlled by Quartica or its affiliates. All such links are provided solely as a convenience to you. If you use these links, you will leave the Website. Neither we nor any of our respective affiliates are responsible for any content, materials or other information located on or accessible from any other web site. Neither we nor any of our respective affiliates endorse, guarantee, or make any representations or warranties regarding any other web sites, or any content, materials or other information located or accessible from any other web sites, or the results that you may obtain from using any other web sites. If you decide to access any other web sites linked to or from this Website, you do so entirely at your own risk.
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8. Access and Interference. You agree that you will not use any robot, spider, scraper or other automated means to access the Website for any purpose without our express written permission. Additionally, you agree that you will not: (i) take any action that imposes, or may impose in our sole discretion an unreasonable or disproportionately large load on our infrastructure; (ii) interfere or attempt to interfere with the proper working of the site or any activities conducted on the Website; or (iii) bypass any measures we may use to prevent or restrict access to the Website.
9. Right to Takedown Content. Except as disclosed in our Privacy Policy, we will not monitor, edit, or disclose the contents of a user’s e-mail unless required in the course of normal maintenance of the Website and its systems or unless required to do so by law or in the good-faith belief that such action is necessary to: (1) comply with the law or comply with legal process served on Quartica or the Website; (2) protect and defend the rights or property of Quartica, the Website, or the users of the Website; or (3) act in an emergency to protect the personal safety of our guests, the Website, or the public. Users shall remain solely responsible for the content of their messages and Quartica shall have no obligation to prescreen any such content. However, we shall have the right in our sole discretion to edit, refuse to post or remove any material submitted to or posted on the Website at any time without notice. Without limiting the foregoing, we shall have the right to remove any material that we find to be in violation of the provisions hereof or otherwise objectionable, and the additional right to deny any user who fails to conform to any provision of these Terms of Service access to the Website.
10. Representations and Warranties. You represent that You are over the age of 18, have the right and authority to enter into this Agreement, are fully able and competent to satisfy the terms, conditions, and obligations herein, and Your use of the Website is and will be in compliance with all applicable laws. You have read, understood, agree with, and will abide by the terms of this agreement.
11. DISCLAIMERS. YOUR USE OF THE WEBSITE AND THE SERVICES ARE AT YOUR RISK. THE INFORMATION, MATERIALS AND SERVICES PROVIDED ON OR THROUGH THE WEBSITE ARE PROVIDED “AS IS” WITHOUT ANY WARRANTIES OF ANY KIND INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, SECURITY OR NON-INFRINGEMENT OF INTELLECTUAL PROPERTY. NEITHER QUARTICA, NOR ANY OF ITS AFFILIATES WARRANT THE ACCURACY OR COMPLETENESS OF THE INFORMATION, MATERIALS OR SERVICES PROVIDED ON OR THROUGH THE WEBSITE. THE INFORMATION, MATERIALS AND SERVICES PROVIDED ON OR THROUGH THE WEBSITE MAY BE OUT OF DATE, AND NEITHER QUARTICA, NOR ANY OF ITS AFFILIATES MAKES ANY COMMITMENT OR ASSUMES ANY DUTY TO UPDATE SUCH INFORMATION, MATERIALS OR SERVICES. THE FOREGOING EXCLUSIONS OF IMPLIED WARRANTIES DO NOT APPLY TO THE EXTENT PROHIBITED BY LAW. PLEASE REFER TO YOUR LOCAL LAWS FOR ANY SUCH PROHIBITIONS. NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED FROM QUARTICA OR THROUGH THE WEBSITE OR SERVICES WILL CREATE ANY WARRANTY NOT EXPRESSLY MADE HEREIN.
12. LIMITATIONS OF LIABILITY. QUARTICA DOES NOT ASSUME ANY RESPONSIBILITY, OR WILL BE LIABLE, FOR ANY DAMAGES TO, OR ANY VIRUSES THAT MAY INFECT YOUR COMPUTER, TELECOMMUNICATION EQUIPMENT, OR OTHER PROPERTY CAUSED BY OR ARISING FROM YOUR ACCESS TO, USE OF, OR BROWSING THIS WEBSITE OR USING THE SERVICES, OR YOUR DOWNLOADING OF ANY INFORMATION OR MATERIALS FROM THIS WEBSITE. IN NO EVENT WILL QUARTICA, OR ANY OF ITS OFFICERS, DIRECTORS, EMPLOYEES, SHAREHOLDERS, AFFILIATES, AGENTS, SUCCESSORS OR ASSIGNS, NOR ANY PARTY INVOLVED IN THE CREATION, PRODUCTION OR TRANSMISSION OF THE WEBSITE, BE LIABLE TO YOU OR ANYONE ELSE FOR ANY INDIRECT, SPECIAL, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, THOSE RESULTING FROM LOST PROFITS, LOST DATA OR BUSINESS INTERRUPTION) ARISING OUT OF THE USE, INABILITY TO USE, OR THE RESULTS OF USE OF THE WEBSITE, OR THE MATERIALS, INFORMATION OR SERVICES CONTAINED ON ANY OR ALL OF THE WEBSITE, WHETHER BASED ON WARRANTY, CONTRACT, TORT OR ANY OTHER LEGAL THEORY AND WHETHER OR NOT ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE FOREGOING LIMITATIONS OF LIABILITY DO NOT APPLY TO THE EXTENT PROHIBITED BY LAW. PLEASE REFER TO YOUR LOCAL LAWS FOR ANY SUCH PROHIBITIONS. IN THE EVENT OF ANY PROBLEM WITH THE WEBSITE OR ANY MATERIALS, INFORMATION OR SERVICES CONTAINED ON ANY OR ALL OF THE WEBSITE, YOU AGREE THAT YOUR SOLE REMEDY IS TO CEASE USING THE WEBSITE AND SERVICES. IN NO EVENT SHALL QUARTICA’S TOTAL LIABILITY TO YOU FOR ALL DAMAGES, LOSSES, AND CAUSES OF ACTION WHETHER IN CONTRACT, TORT (INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE), OR OTHERWISE EXCEED THE GREATER OF (A) TWENTY FIVE DOLLARS (US $25.00) OR (B) THE VALUE OF THE SERVICES PURCHASED OR SUBSCRIBED BY YOU ON THE WEBSITE.
13. Indemnity. You agree to defend, indemnify and hold Quartica and any affiliated company or individual harmless from any and all liabilities, costs, and expenses, including reasonable attorneys’ fees, related to or in connection with (i) the use of the Website, the Services or the internet or your placement or transmission of any message or information on this Website by you or your authorized users; (ii) your violation of any term of this Agreement, including without limitation, your breach of any of the representations and warranties above; (iii) your violation of any third party right, including without limitation any right of privacy, publicity rights or Intellectual Property Rights; (iv) your violation of any law, rule or regulation of the United States or any other country; (v) any claim or damages that arise as a result of any User Submission that you provide to Quartica; or (vi) any other party’s access and use of the Website with your unique username, password or other appropriate security code.
14. Release. In the event that you have a dispute with one or more other users of the Website, you release Quartica (and our officers, directors, agents, subsidiaries, joint ventures and employees) from claims, demands and damages (actual and consequential) of every kind and nature, known and unknown, suspected and unsuspected, disclosed and undisclosed, arising out of or in any way connected with such disputes.
15. Termination. You or we may suspend or terminate your account or your use of this Website or access to the Services, at any time, for any reason or for no reason. You are personally liable for any orders placed or charges incurred through your account prior to termination. We may also block your access to our Website and/or the Services in the event that (a) you breach these Terms of Service; (b) we are unable to verify or authenticate any information you provide to us; or (c) we believe that your actions may cause financial loss or legal liability for you, our users or us.
16. Force Majeure. Neither Quartica nor you shall be responsible for damages or for delays or failures in performance resulting from acts or occurrences beyond their reasonable control, including, without limitation: fire, lightning, explosion, power surge or failure, water, acts of God, war, revolution, civil commotion or acts of civil or military authorities or public enemies: any law, order, regulation, ordinance, or requirement of any government or legal body or any representative of any such government or legal body; or labor unrest, including without limitation, strikes, slowdowns, picketing, or boycotts; inability to secure raw materials, transportation facilities, fuel or energy shortages, or acts or omissions of other common carriers.
17. Privacy. Quartica’s data collection and use practices, including data collection and use of personally identifiable information can be found in Quartica’s Privacy Policy.
18. Dispute Resolution. PLEASE READ THE FOLLOWING ARBITRATION AGREEMENT IN THIS SECTION (“ARBITRATION AGREEMENT”) CAREFULLY. It requires you to arbitrate disputes with Quartica and limits the manner in which you can seek relief from us.
  - Applicability of Arbitration Agreement. You agree that any dispute or claim relating in any way to your access or use of the Services or to any aspect of your relationship with Quartica, will be resolved by binding arbitration, rather than in court, except that (1) you may assert claims in small claims court if your claims qualify, and (2) you or Quartica may seek equitable relief in court for infringement or other misuse of intellectual property rights (such as trademarks, trade dress, domain names, trade secrets, copyrights, and patents). This Arbitration Agreement shall apply, without limitation, to all claims that arose or were asserted before the Effective Date of these Terms or any prior version of these Terms.
  - Arbitration Rules and Forum. The Federal Arbitration Act governs the interpretation and enforcement of this Arbitration Agreement. To begin an arbitration proceeding, you must send a letter requesting arbitration and describing your claim to our registered agent, National Registered Agents, Inc. 155 Federal Street; Suite 700, Boston, MA 02110. The arbitration will be conducted by JAMS, an established alternative dispute resolution provider. Disputes involving claims and counterclaims under $250,000, not inclusive of attorneys’ fees and interest, shall be subject to JAMS’s most current version of the Streamlined Arbitration Rules and procedures available at https://www.jamsadr.com/rules-streamlined-arbitration/; all other claims shall be subject to JAMS’s most current version of the Comprehensive Arbitration Rules and Procedures, available at https://www.jamsadr.com/rules-comprehensive-arbitration/. JAMS’s rules are also available at www.jamsadr.com or by calling JAMS at 800-352-5267. If JAMS is not available to arbitrate, the parties will select an alternative arbitral forum. If the arbitrator finds that you cannot afford to pay JAMS’s filing, administrative, hearing and/or other fees and cannot obtain a waiver from JAMS, Quartica will pay them for you. In addition, Quartica will reimburse all such JAMS’s filing, administrative, hearing and/or other fees for claims totaling less than $10,000 unless the arbitrator determines the claims are frivolous. You may choose to have the arbitration conducted by telephone, based on written submissions, or in person in the country where you live or at another mutually agreed location. Any judgment on the award rendered by the arbitrator may be entered in any court of competent jurisdiction.
  - Authority of Arbitrator. The arbitrator shall have exclusive authority to (a) determine the scope and enforceability of this Arbitration Agreement and (b) resolve any dispute related to the interpretation, applicability, enforceability or formation of this Arbitration Agreement including, but not limited to any claim that all or any part of this Arbitration Agreement is void or voidable. The arbitration will decide the rights and liabilities, if any, of you and Quartica. The arbitration proceeding will not be consolidated with any other matters or joined with any other cases or parties. The arbitrator shall have the authority to grant motions dispositive of all or part of any claim. The arbitrator shall have the authority to award monetary damages and to grant any non-monetary remedy or relief available to an individual under applicable law, the arbitral forum’s rules, and these Terms (including the Arbitration Agreement). The arbitrator shall issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded. The arbitrator has the same authority to award relief on an individual basis that a judge in a court of law would have. The award of the arbitrator is final and binding upon you and us.
  - Waiver of Jury Trial. YOU AND COMPANY HEREBY WAIVE ANY CONSTITUTIONAL AND STATUTORY RIGHTS TO SUE IN COURT AND HAVE A TRIAL IN FRONT OF A JUDGE OR A JURY. You and Quartica are instead electing that all claims and disputes shall be resolved by arbitration under this Arbitration Agreement, except as specified in Section 18.1(a) above. An arbitrator can award on an individual basis the same damages and relief as a court and must follow these Terms as a court would. However, there is no judge or jury in arbitration, and court review of an arbitration award is subject to very limited review.
  - Waiver of Class or Other Non-Individualized Relief. ALL CLAIMS AND DISPUTES WITHIN THE SCOPE OF THIS ARBITRATION AGREEMENT MUST BE ARBITRATED ON AN INDIVIDUAL BASIS AND NOT ON A CLASS OR COLLECTIVE BASIS, ONLY INDIVIDUAL RELIEF IS AVAILABLE, AND CLAIMS OF MORE THAN ONE CUSTOMER OR USER CANNOT BE ARBITRATED OR CONSOLIDATED WITH THOSE OF ANY OTHER CUSTOMER OR USER. If a decision is issued stating that applicable law precludes enforcement of any of this subsection’s limitations as to a given claim for relief, than then claim must be severed from the arbitration and brought into the State or Federal Courts located in the Commonwealth of Massachusetts. All other claims shall be arbitrated.
  - 30-Day Right to Opt Out. You have the right to opt out of the provisions of this Arbitration Agreement by sending written notice of your decision to opt out to privacy@quartica.com within 30 days after first becoming subject to this Arbitration Agreement. Your notice must include your name and address, your Quartica username (if any), the email address you used to set up your Quartica account (if you have one), and an unequivocal statement that you want to opt out of this Arbitration Agreement. If you opt out of this Arbitration Agreement, all other parts of these Terms will continue to apply to you. Opting out of this Arbitration Agreement has no effect on any other arbitration agreements that you may currently have, or may enter in the future, with us.
  - Severability. Except as provided in subsection 18.1(e), if any part or parts of this Arbitration Agreement are found under the law to be invalid or unenforceable, then such specific part or parts shall be of no force and effect and shall be severed and the remainder of the Arbitration Agreement shall continue in full force and effect.
  - Survival of Agreement. This Arbitration Agreement will survive the termination of your relationship with Quartica.
  - Modification. Notwithstanding any provision in these Terms to the contrary, we agree that if Quartica makes any future material change to this Arbitration Agreement, you may reject that change within thirty (30) days of such change becoming effective by writing Quartica to privacy@quartica.com.
19. General. Any claim relating to, and the use of, this Website, the Services and the materials contained herein is governed by the laws of the Commonwealth of Massachusetts. You consent to the exclusive jurisdiction of the state and federal courts located in Suffolk County, Massachusetts. A printed version of these Terms of Service will be admissible in judicial and administrative proceedings based upon or relating to these Terms of Service to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form. We do not guarantee continuous, uninterrupted or secure access to our Website or the Services, and operation of the Website may be interfered with by numerous factors outside of our control. If any provision of these Terms of Service is held to be invalid or unenforceable, such provision shall be struck and the remaining provisions shall be enforced. You agree that these Terms of Service and all incorporated agreements may be automatically assigned by Quartica in our sole discretion. Headings are for reference purposes only and in no way define, limit, construe or describe the scope or extent of such section. Our failure to act with respect to a breach by you or others does not waive our right to act with respect to subsequent or similar breaches. These Terms of Service set forth the entire understanding and agreement between us with respect to the subject matter hereof. All sections which by their context ought to survive this agreement shall survive any termination or expiration of this Agreement.
20. Entire Agreement. These terms and conditions are the entire agreement between the user and Quartica and supersede any prior understandings or agreements (written or oral).
21. Additional Assistance. If you do not understand any of the foregoing Terms of Service or if you have any questions or comments, we invite you to contact our Customer Service Department by email at support@quartica.com.
22. Copyright Notice. All Website design, graphics, text selections, arrangements, and all software are Copyright © 2019, Quartica, Inc. or its licensors. ALL RIGHTS RESERVED.

Last Changes to Terms of Service: February 15, 2019

Regulatory Intelligence

Ad/Prom

Submissions

CMC Changes

Regulatory Intelligence

MARS Platform

Ad/Prom

Submissions

CMC Changes

Regulatory Intelligency

MARS Platform

REGULATORY INTELLIGENCE

Benefits

Ready to automate your Regulatory Intelligence management process?

Key Features