compliance  +  regulatory  +  training
Services - Regulatory
 
After Dr. Wagner worked for one year as the internal auditor for a medical device company, the client filled out our Client Quality Assessment: “Most of the consultant services used in the past were very specific in the scope of their activities. SCI provided general guidance through the auditing activities that provided more of a global perspective of the quality systems activities. Overall, the comments, suggestions and insight provided by SCI gave us a positive direction for improving our quality systems.”

We provide the following domestic and international regulatory affair services:

  • Develop Regulatory strategies for domestic or global markets
  • IMPD and IND submissions
  • Clinical trial approval/exemption applications or notifications in Europe and USA
  • IND amendments and annual reports
  • Orphan Drug Designation Requests for Rare Diseases
  • NDA's for US submission and MAA dossiers and Expert Reports for EU submission
  • Abridged MAAs
  • Chemistry, Manufacturing and Controls documentation
  • Nonclinical Toxicology, Pharmacology, ADME documentation and summaries
  • Clinical documentation and summaries
  • Preparation of Summaries of Product Characteristics (SmPCs) and package inserts
  • Mutual Recognition submissions
  • EU Centralised Applications
  • Submission and follow-up of applications with the regulatory authorities
  • DMF preparation
  • Standard Operating Procedures, Batch Records, Tech Transfer Documentation
  • Planning, rehearsing and attending Regulatory Authorities, EMEA, CPMP etc, meetings
  • Advice on product classification and regulatory strategy for borderline products, including herbal medicines and/or nutraceuticals