(410) 309-3145

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SciRegs

SciRegs International, Inc. is a U.S. based scientific and regulatory affairs consulting firm and U.S. Regulatory Agent for drug companies and drug distributors, DMF holders and testing laboratories.

 

About Us

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

 

New Drug Applications (NDA & ANDA)

  • Audit

  • ​Annual and Periodic Reporting

  • Compilation and Preparation

  • CTD Structuring

  • Electronic CTD creation and submission

  • Product Development

  • Training

Drug Master Files (DMF)

  • Audit

  • Annual Reporting

  • Compilation and Preparation

  • CTD Structuring

  • Electronic CTD creation and submission

  • Training

Other Services

  • Blind eCTD Submission

  • Cloud-based Electronic Document Management System (EDMS)

  • Electronic Drug Product Registration and Listing

  • Electronic Facility Registration

  • Electronic GDUFA Registration

  • Electronic Labeler Code Request

  • Structured Product Labeling (SPL) creation

MedWatch

Safety Information and Adverse Event Reporting which includes:

  • 1-800 Telephone Reporting

  • Centralized E-Mail Reporting

  • Collaboration

  • Consumer Inquiries Safety Reporting Portal (SRP) submission

Contact Us

6333 Summercrest Dr, Columbia, MD 21045, USA

(410) 309-3145