Global regulatory Operations

FMD K&L offers the experience and expertise to serve as your preferred partner in global regulatory affairs, assisting to meet strict deadlines, effectively maintain operational costs, and gain approvals across multiple global markets
Regulatory Affairs:Global Regulatory Operations
We can help achieve your objectives with our consultative approach, and comprehensive oversight of activity throughout the approval cycle. We strive to exceed your expectations in terms of:
  • Compliance
  • Quality
  • Timeliness
  • Cost effectiveness

Our team is comprised of expert regulatory affairs associates and regulatory operations professionals, experienced and skilled in the preparation, compilation, and delivery of regulatory submissions. Our team brings together the knowledge, skill, and expertise ensuring accuracy, accountability, and responsiveness throughout the entire regulatory cycle.

Our services include:
  • Pre-approval assistance
  • Post-marketing assistance
  • Product lifecycle management

Pre-approval assistance:

  • Compile dossiers per US FDA requirements for investigational new drug (IND), new drug application (NDA), biologics license application (BLA) & abbreviated new drug application (ANDA)
  • Compile dossiers per EU legislation for Marketing Authorization Application (MAA) via Centralized Procedure (CP), National Procedure (NA), Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP), and/or Repeat Use Procedure (RUP)
  • Prepare bibliographic and line extension applications for EU regions
  • Compile dossiers for Latin America (LATAM) & Asia Pacific (APAC) per regulatory guidelines, including direct submissions for various agencies
  • Multilingual submissions for local registrations
  • Compile & publish common technical documents (CTD), eCTD & non-eCTD electronic submission (NeeS) modules for US, Canada, APAC & EU regions
  • Structured Product Labeling (SPL) publishing
  • Support for medical device development, including assistance in 510(K), pre-market approval (PMA) & de novo submissions to FDA
  • Prepare product information (SmPC/PL/Label), PIF & mockups
  • Advise on EU directives to achieve compliant CE marking
  • Eligible to act as regulatory authorized representative for non-EU manufacturers without an office in EU member state
  • Assign Unique Device Identification (UDI) numbers for medical devices

Post-marketing assistance

  • Preparation of, and assistance with, submission of amendments, supplements & variations to marketing authorizations
  • Annual reports for IND, BLA & NDA
  • Review of changes to advertising & promotional materials
  • Renewal of licenses for Rest of World (ROW) countries
  • Help with EU renewal procedures (CP/NA/MRP/DCP/RUP) & full support for all steps, from preparing the application form to compiling the documentation to granting the renewal
  • Provide responses within stipulated timelines on queries/deficiencies raised by health authorities & customers
  • Reformulation of cosmetic products for submission to global regulatory agencies, including raw material assessments, ingredient list generation, toxicity testing, labeling, dossier preparation & registration