Who we are:

888 Pharmaceutical is a potent regulatory team comprised of industry leading professionals in FDA and international regulatory affairs. Our veteran consultants have been hand-picked to provide the highest level of regulatory guidance.

How we can help:

In an increasingly competitive pharmaceutical environment it can be difficult to keep track of the details. If your business or submission has been cited for a deficiency, or if you just need an extra hand on the occasional annual report, our friendly experts are here to help.

What we specialize in:

In the current pharmaceutical arena, generics and biosimilars are a growing industry.  At 888 our staff specializes in generic strategy and generic regulatory affairs. With generics as our focus we offer a broad spectrum of services that cover everything from quality audits to CMC change reporting.

Services We Provide:

Compounding Compliance

In 2012, the FDA stated its intent to drastically increase audits of pharmacy compounding facilities. In six months there have been 40+ citations issued; this is 40x more than the previous average of one citation per year. It is now more important than ever to ensure your facility is audit ready. Our specialists have extensive experience in FDA audit preparation, support, and risk-mitigation. If you have already been cited or are nearing non-compliance for a deficiency, our staff can assist in agency correspondence and response preparation.

How we can help:

  • Internal Auditing
  • Audit Support
  • Non-Compliance Risk Mitigation
  • Deficiency Response

Pharmaceuticals

With over 25 years’ experience in providing regulatory submission support for new and complex post-approval generic applications (ANDAs), our seasoned consultants have seen it all and know how to get it done right, the first time. We have successfully filed and supported new drug applications for small generic pharmaceutical manufacturers as well as fortune 100 pharmaceutical heavyweights. Our senior consultants are considered thought leaders in generic filing strategy and have assisted clientele in efficient and cost-effective filing.

How we can help:

  • GMP Establishment Qualification Support
  • New Product Registration and Submission Preparation
  • Filing Strategy
  • Labeling
  • eCTD Conversion
  • DMF reviews

Agency Correspondence:

  • Deficiency Response
  • FDA Communication
  • International Agency liaisoning
  • Safety and Pharmacovigilance

Publishing

CMC submission publishing can be a tedious, time-consuming process. Preparing submissions in an eCTD format may not only drastically decrease the preparation time of future submissions but decreases agency review time and future publishing costs. Not ready to submit in full eCTD? No problem, our staff is experienced in hybrid submissions to simplify the eCTD transition.

Agency Correspondence:

  • CMC Submission Publishing
  • eCTD Preparation
  • Non-CTD to CTD conversion and Support
  • Hybrid Submissions
  • FDA Gateway Registration and Setup

About Us

888 Pharmaceutical is a Global Regulatory Affairs Consulting firm with over 25 years experience in providing regulatory submission support for new and complex post- approval generic applications (ANDAs). We have successfully filed and supported new drug applications for small generic pharmaceutical manufacturers as well as fortune 100 pharmaceutical manufacturers.

Contact Us

Interested in getting a proposal? Fill out the contact form below and will get back to you as soon as possible.

Contact Details
1.949.378.3884
888 Pharmaceutical, LLC.
222 N. 13th St. Suite 200
Boise, Idaho 83702