Regulatory Documentation

Our experienced technical writers can provide a full range of support for your filing needs, ranging from authorship of the full documents (or individual sections) to review, gap analysis, and editing of your existing draft documents. Our diverse team’s experience spans a wide range of global jurisdictions and stages of development, from preclinical through clinical, designations, and marketing approval (BLA, MAA).

US FDA

Biologics

Submissions:

  • Investigational New Drug (IND)
  • ~Original and amendments
  • Biologics Licensure Application (BLA)
  • ~Original, amendments, post approval supplements
  • Master File

Designations:

  • Orphan Drug Designation (ODD)
  • Rare Pediatric Disease (RPD)
  • Fast Track (FT)
  • Breakthrough (BT)
  • ~designation request
  • ~post-designation initial comprehensive multidisciplinary meeting
  • RMAT
  • ~designation request
  • ~post-designation initial comprehensive multidisciplinary meeting
  • CMC Readiness Pilot applications
  • Advanced Manufacturing Technology designation

Meeting Packages:

  • INTERACT
  • Pre-IND
  • End of Phase 1 (EOP1)
  • End of Phase (EOP2)
  • Pre-BLA
  • Other: Type A, B, C, D
  • CATT (Committee for Advanced Therapies) meeting

Other:

  • Initial Pediatric Study Plan (iPSP)
  • Long Term Follow-Up (LTFU) Protocol
  • Clinical Special protocol assessment (SPA) request
  • Annual Reports
  • DSUR
  • Safety Reports  
  • Office of Combination Products Request for Designation (RFD)
  • Exemptions and Alternatives request per 21 CFR 1271.155

Medical Devices

  • Pre-Request for Designation (Pre-RFD)
  • Request for Designation (Medical Devices Primary Mode of Action)
  • ~Device Constituent – OCP (Office of Combination Product)
  • ~Combination Product Agreement Meeting (CPAM)
  • Product Development Plan (PDP)
  • Q-Submission Meetings
  • ~Breakthrough Device
  • IDE (Investigational Device Exemption)
  • HDE (Humanitarian Device Exemption)
  • 510(k)
  • ~Traditional
  • ~Abbreviated
  • ~Substantial Equivalent
  • Premarket Approval Application (PMA)
  • ~Original
  • ~Supplements
  • De Novo

Bioprocessing Manufacturing Equipment

  • CATT meeting
  • AMT Advanced Manufacturing Technology Designation
  • Device Master File (MAF)

EU (EMA and National Competent Authorities) and UK MHRA

Dossiers

  • Investigational Medicinal Product Dossier (IMPD)
  • Clinical Trial Application
  • Marketing Authorization Application

Meetings:

  • Innovation Task Force (ITF)
  • Scientific advice

Designations and Special Procedures:

  • Classification as Advanced Therapy Medicinal Product
  • Certification of quality and non-clinical data
  • PRIME (Priority Medicines)
  • Orphan Medicinal Product

Other Jurisdictions:

Japan
Canada
Brazil
Australia
Israel

PMDA
Health Canada
ANVISA
TGA
Ministries of Health

Pre-consultation & consultation
IND/CTA, Pre-CTA
CTA
CTA
IMPD