Aroga Bio Sciences

(on high bluff drive)
Printing and Publishing Services in San Diego, CA
Printing and Publishing Services

Location

12526 High Bluff Drive
San Diego, CA
92130

About

Aroga Biosciences is a boutique consulting group that provides highly experienced regulatory writing services for biotech and pharmaceutical projects. We are a team of Ph.D.-level scientists with extensive regulatory and medical writing experience in a broad range of therapeutic areas. Our writers have in-depth experience with regulatory and publishing standards so we can ensure each document is submission ready. Our scientific backgrounds allow us to understand content at a fundamental level, which aids us in conveying messaging appropriately for its intended audience.

Photos

Aroga Bio Sciences Photo

Services

  • Clinical Study Reports
  • Clinical CTD summary documents for marketing applications (NDAs and BLAs)
  • Protocols and protocol amendments
  • Investigator’s brochures
  • INDs
  • Regulatory responses
  • Briefing packages
  • Pediatric study plans/Pediatric Investigational Plans
  • Orphan drug application/European Orphan Medicinal Product Designation (OMPD)
  • White papers
  • PSURs/DSURs
  • Risk Management Plans
  • Company Core Safety Information
  • Development Core Safety Information
  • Manuscripts/abstracts
  • Publication planning
  • Submission/Project Management
  • Dossier Strategy/Submission Planning
  • Clinical Development Plans
  • Formatting
  • Assembly of CSR appendices
  • Bookmarking/hyperlinking of documents
  • Review against statistical data (tables and listings etc.)
  • Regulatory publishing readiness
  • Consistency in messaging, cohesiveness, grammar, and style guidelines

Latest

One of the benefits of a boutique firm is the ability to work closely as a team to meet our client objectives efficiently. We are reeling from the latest great feedback from one of our clients. Please visit us at www.arogabio.com to learn how our team can help meet your #regulatorywriting objectives.
To close out #arogabio spotlight week, we wanted to feature an "outside-of-work" interest for Elizabeth Clarke. She loves Mountaineering, and together with her husband, she has climbed close to 90 peaks in the Sierra Nevadas, Cascades and Rockies mountain ranges. It's no wonder she excels at juggling tight timelines and persevering her way through real-time strategic #regulatorywriting projects.
More from #arogabio spotlight week! Elizabeth Clarke talks about her passion for #regulatorywriting and the #arogabio team.
To begin employee spotlight week at Aroga Biosciences, we asked our regulatory medical writer, Elizabeth Clarke, MS, MPH, PhD, about how she got into #medicalwriting...
As #arogabio is expanding, we thought it would be nice to feature an employee spotlight with Elizabeth Clarke, one of our lead regulatory medical writers. Next week, she will be answering questions related to her background and experience at #arogabio. Stay tuned for more! #arogalife #strenghtfromscience
The #arogabio team is hiring! If you or someone you know is looking to grow a career in #regulatorywriting, our west-coast based boutique consulting firm might the place. Please visit our careers page https://www.arogabio.com/careers/ to learn more about the opportunity.
Rigor—applying the scientific method in the strictest sense to ensure an unbiased experimental design, analysis, interpretation, and reporting of results. At #arogabio we strive to provide our clients with regulatory writing services following a full examination of scientific evidence and by following the scientific method. This article is worth a read and solidifies the need for balanced reporting of scientific data. https://apple.news/ADYlpZDdQQ0iBzCVdzGC1HA #arogabio #strengthfromscience #scientificrigor APPLE.NEWS What the Pandemic Has Taught Us About Science — The Wall Street Journal
The primary purpose of #QC in #regulatorywriting is to verify accuracy of the data and scientific messaging presented in the document. That sounds simple enough, right? There is actually more to it than one might think, which is why we have added a full-time QC specialist to the #arogabio team. Contact us at www.arogabio.com and let us know how we can take your #QC task to the highest level of detail.
Discovery and development of cancer immunotherapy has always been a cause that #arogabio has been passionate about. Our founder, @Krithi Bindal will be attending the Cancer Research Institute virtual awards gala tomorrow. We are thrilled to have the opportunity to hear keynote speaker Nobel Laureate, Dr. Jim Allison again. #arogalife #cancerresearch #cri #mdandersonalumni https://fundraise.cancerresearch.org/event/2020-cri-virtual-awards-gala/e300019
The #arogabio team just completed a first draft Investigators Brochure. It’s our job to develop IB’s in a concise, simple, objective, balanced, and non-promotional format and we always love great feedback from our clients. #happyclients #regulatorywriting
In support of Breast Cancer Awareness month, we could not be more proud to contribute to the development of breast cancer treatments. #aroga=freefromdisease #fightbreastcancer #thinkpink #womenshealth #breastcancerawareness
Our new #arogabio team member, Molly McNamara, has already received great feedback on the latest QC project she completed! Our boutique firm continues to prove we are flexible and extremely detailed. #boutiquefirm #flexibility #regulatorywriting
At #arogabio we have a lot to be thankful for this year. Our clients, our team, our growth, and lastly, our involvement in helping patients get the treatments they need. We asked our team to share what they are thankful for as well. #happythanksgiving #teamwork #collaboration #arogalife
Our founder and principal, @KrithiRaoBindal is honored to be on the speakers panel at her alma mater, UT MD Anderson Cancer Center tomorrow November 18 @ 11:00 am PST. In “From Bench to Business & Entrepreneurship,” she will be talking about navigating different stages of a career in science along with strategies for leveraging training to pursue a path to entrepreneurship.
Rapid responses for regulatory agencies require highly specialized expertise combined with a strong agreed upon strategy, AND teamwork. The #arogabio team recently helped one of our clients meet an important deadline. Projects like this help us feel a great sense of accomplishment for both our team and our clients. #regulatorywriting #rapidresponse #strategy
Very promising interim data from the Phase III COVID-19 vaccine trial was announced yesterday. The data suggest a 90% efficacy rate for the vaccine. As more data is accumulated and analyzed, there is a possibility that the efficacy percentage may shift. There were no serious safety signals. #strengthfromscience For more details check out the article: http://ow.ly/Q87V50Cgc01 http://ow.ly/yang50Cgemu
As a distraction from the unknowns of #electionday, we thought it would be fun to share how the #arogabio team celebrated Halloween this year.
Happy Halloween from the #arogabio team! Halloween looks a little different this year; How are you planning to celebrate? #trickortreat
Aroga Biosciences was featured in, "The Faces of San Diego, 2021," in the January issue of San Diego Magazine. The write-up highlights our company, culture, and shared passion for the opportunity to improve patient outcomes. #arogalife #regulatorymedicalwriting #biotechnology
To close out #arogabio spotlight week, we like to feature an outside-of-work interest. One of Bhavika's passions is bodybuilding and strength training. Fitness has positively impacted her life in so many aspects, and she finds it gratifying to see her progress advance over time through consistency and discipline. It's no wonder she excels at #regulatorywriting through her dedication to clients and hard work. #arogalife #strenghtfromscience
For #employeesplotlight, week we asked Bhavika Patel, PharmD, what the most difficult aspect of her job is. See below as she describes the enjoyable yet challenging aspect of drafting #clinicalprotocols. #arogalife #strengthfromscience #regulatorywriting
#Regulatorywriting is such a niche career choice... For Employee Spotlight Week, we like to know how our #arogabio team members land in this profession. Regulatory Medical Writer, Bhavika Patel, PharmD, highlights her path below! #employeespotlight #patientimpact
Employee spotlight week is back! We are excited to feature one of our latest #arogabio team members, Bhavika Patel. Stay tuned for the remainder of this week to learn more about her background and interests. #arogalife #strengthfromscience
At #arogabio we work hard to best support your early clinical program. We just led a client through their initial IND and have made great progress towards their application submission. #regulatorywriting #INDprocess #INDapplication

Information

Company name
Aroga Bio Sciences
Category
Printing and Publishing Services
Est
2019

FAQs

  • What is the phone number for Aroga Bio Sciences in San Diego CA?
    You can reach them at: 858-925-6145. It’s best to call Aroga Bio Sciences during business hours.
  • What is the address for Aroga Bio Sciences on high bluff drive in San Diego?
    Aroga Bio Sciences is located at this address: 12526 High Bluff Drive San Diego, CA 92130.