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Regulatory Submissions

BioPoint provides consultants with extensive experience in designing and developing successful global regulatory submissions. The regulatory process is only becoming more and more complex, making it more important than ever for every aspect of the submission process to be spot-on.

Biopoint consultants have an exceptionally diverse background in regulatory document and submission preparation, which includes:

  • Abbreviated new drug applications (ANDA)
  • Biologics license applications (BLA)
  • Clinical trial authorization/application/exemptions (CTA/CTX)
  • Clinical trial notifications (CTN)
  • Common technical document (CTD/eCTD)
  • Drug master files (DMF)
  • Fast track applications
  • Investigational drug exemptions (IDE)
  • Investigational new drug applications (IND)
  • Marketing authorization applications (MAA)
  • New drug applications (NDA)
  • New drug submissions (NDS)
  • Orphan drug applications (ODA)
  • Premarket approvals (PMA)/510(k)

A proper regulatory submission is one of the most important aspects of the entire process. A quality submission makes all the difference in your product or drug going to market sooner, which not only maximizes investments quicker, but allows the product itself to begin helping patients even sooner as well.

Learn More About Our Process for Developing Regulatory Submissions

Our consultants will work closely with you to ensure that every step of the submission process accurately navigates the complex landscape of the regulatory world. No matter the type of your submission, we can help it successfully reach its ultimate goal as quickly as possible.

For more information on how we can provide high-quality regulatory submission support to your company, be sure to contact Biopoint today at 781-218-3790 or online.

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