SciRegs International, Inc. is a US based scientific and regulatory affairs consulting firm and US Regulatory Agent for drug companies and drug distributors, DMF holders and testing laboratories.  SciRegs International, Inc. was formed in 1997 and commands over 55 years of combined work experience at the Food and Drug Administration, United States Pharmacopeia, and in industry.  This experience includes regulatory affairs (electronic filing of drug applications and drug master files, drug registration and listing), clinical supplies management, pharmaceutical, and cosmetic manufacturing, equipment and process validation, packaging development, analytical method development, project planning, and research. SciRegs is frequently called upon to audit approved drug applications or facilities prior to purchase.  In addition to a substantial knowledge of regulations, Code of Federal Regulations Title 21 requirements including cGMPs, cGLP’s, and FDA and USP policy, SciRegs International, Inc. can assist in product development, analytical methods, filing drug applications and drug master files, and facility Quality System Master Plans, IQ, OQ, PQ, and auditing.  SciRegs conducts training seminars, providing written and oral presentations and project management, in the United States and internationally.  SciRegs is a cGMP-international consulting corporation, specializing in pharmaceuticals, medical products, and packaging and stability.

eCTD filing requires a validated computer program and significant training to master the filing.  SciRegs International, Inc. can be contracted to develop or convert your Drug Master Files to electronic format for filing.

Services Provided by SciRegs International, Inc. include:
  • MedWatch
  • Facility audit and inspection
  • SOP writing
  • SOP auditing
  • SPL (structured product labeling) creation
  • Electronic Drug Registration and Listing
  • Electronic Facility Listing
  • Electronic Labeler Code Request
  • DMF training
  • DMF writing
  • DMF audit
  • DMF electronic filing
  • eANDA number requests
  • ANDA eCTD training
  • ANDA Research and Development
  • ANDA writing
  • ANDA audit
  • ANDA electronic filing (eCTD format)
  • Pharmaceutical Consulting