Submissions

Optimize regulatory submissions business processes using MARS

SUBMISSIONS

The emergence and enforcement of standards for regulatory submissions worldwide over the last few years have been gradually introducing consistency and standardization. The ad-hoc nature of submissions in the past was fairly unpredictable from a timeline, resource, and infrastructure perspective. This coupled with parallel submissions, dependencies and multiple product lines introduced tremendous challenges to ensure regulatory commitments to agencies are met in time. The ability to allocate the right resources with the correct skill sets across submissions and products is a challenging endeavor.

Quartica solution can help manage the process of submissions from inception to delivery to the agency. It will help manage regulatory submissions worldwide using a precise, consistent and predictable submissions process.

Benefits

Automate scheduling and planning of regulatory submissions

Automate authoring of regulatory documents and reports.

Generate pre-configured variance, KPI and timeline reports

Ensure conformance to standards, templates and regulations.

Ready to optimize your regulatory submissions process?

Key Features

One stop shop to manage submission planning authoring and distribution.
Manage submission documents, components and dependencies across products and submissions.
View impact across submissions by establishing dependencies across products and submissions.

Automate calculation of submission and submission component dates.
Re-calibrate dates based on changes at any stage in the timeline.
Baseline transition timeline of document(s) from one stage to another. (Ex: QoS Drug Substance document)

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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

Submissions

Ad/Prom

Submissions

CMC Changes

Regulatory Intelligence

MARS Platform

Ad/Prom

Submissions

CMC Changes

Regulatory Intelligency

MARS Platform

SUBMISSIONS

Benefits

Ready to optimize your regulatory submissions process?

Key Features