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. 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, cGLPs, 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. Safety Information and Adverse Event Reporting which includes:
View Top Employees from SciRegs International IncWebsite | http://www.sciregs.com |
Revenue | $4 million |
Employees | 2 (2 on RocketReach) |
Address | 6333 Summercrest Dr, Columbia, Maryland 21045, US |
Phone | (410) 309-3145 |
Industry | Manufacturing General, Manufacturing |
Competitors | CMC Pharmaceuticals, Inc., Dow Development Laboratories, LLC (DDL), HARTMANN WILLNER, LLC, Pharmaceutical Development Group |
SIC | SIC Code 283 Companies, SIC Code 28 Companies |
NAICS | NAICS Code 3254 Companies, NAICS Code 32541 Companies, NAICS Code 325 Companies, NAICS Code 32 Companies |
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The SciRegs International Inc annual revenue was $4 million in 2024.
Brian McInvale is the Head of Finance and Accounting of SciRegs International Inc.
2 people are employed at SciRegs International Inc.
SciRegs International Inc is based in Columbia, Maryland.
The NAICS codes for SciRegs International Inc are [3254, 32541, 325, 32].
The SIC codes for SciRegs International Inc are [283, 28].