Regulatory Affairs

Regulations are in constant flux, given continuous innovation in healthcare technologies and country- and region-specific adaptations. Our regulatory affairs team helps you navigate this dynamic landscape to ensure that your products and processes meet all relevant regulatory requirements.

Knowledge of the regulations is not enough. Familiarity with the various global regulatory groups and their preferences is essential to achieve the most efficient and successful outcomes. At Allucent Consulting™, we have gained this fluency through frequent interactions with different regulatory sections, including FDA, Health Canada, EMA, MHRA, and agencies in APAC, often presenting innovative products to treat challenging indications.

Our team of regulatory experts, comprising top-notch experts with advanced degrees including Ph.D., Pharm.D., and M.D., has a long-standing reputation for excellence in regulatory strategy and submission preparation. We complete approximately 750 submissions of various types annually.

Allucent regulatory solutions include the following:

Choosing the right regulatory strategy can mean the difference between a streamlined approval process or a drawn-out, expensive process. We have the proven expertise to design effective regulatory strategies to ensure an efficient approval process. Our team efficiently translates that strategy into the right documents for regulatory agency review, including the following.

Regulatory development milestone meetings and interactions:

  • Application Orientation meetings (U.S. AOM)
  • Product development meetings
  • Pre-submission and pre-application meetings (U.S. FDA, EMA, Health Canada, MHRA, and regulators in APAC)
  • EMA-FDA Parallel Scientific Advice
  • Oncologic Drugs Advisory Committee meetings (U.S.)
  • Advisory Committee meetings (U.S.)
  • Recombinant DNA Advisory Committee (RAC) meetings
  • Special protocol assessments (SPAs)

Marketing approval submissions:

Pediatric development:

Designations and expedited programs:

  • Fast Track Designation
  • Breakthrough Therapy Designation
  • Accelerated Approval
  • Priority Review Designations
  • Orphan Drug Designations
  • Priority Medicines (PRIME)
  • Innovative Licensing and Access Pathway (ILAP)
  • Request For Designation (RFD)
  • De Novo Classification Request

Clinical trial application submissions: