Experienced with,

Through the years we've acquired considerable experience with a variety of consumer product industries, generally dscribed as cosmetics, drugs and medical devices. Refer to the table below.

Cosmetics

Drugs (OTC)

Devices:

Loose powder

Quick release tablets:

Ointments

Pressed powder

Granulated

Transdermal intermediates

Creams and lotions

Direct compression

Technical expertise:

Mascaras

Hybrids

Web handling systems

Lip glosses

Syrups (internal)

Measurement systems

Ointments

Lotions

Inspection systems

Lip sticks (silicone & flood mold)

Suspensions


Suspensions

Isotonics (non-sterile)

OTC review:

Emulsions

Transdermal systems:

Monitoring changes


Reservoir

Verifying conformance


Matrix (drug in adhesive)


Our experience is very diverse but has a high concentration in pervasively regulated consumer product industries, such as those regulated by Food and Drug, Drug Enforcement Administration, Environmental Protection Agency, Bureau of Alcohol, Tobacco and Firearms and including many Sate equivalents.

Agency

Regulations

Topics

FDA

Part 211

GMP Finished Pharmaceuticals


Part 700

Cosmetics


Part 820

Device regulations


Part 1300

DEA


Drug Listing

SPL generation to ESG account




DEA

Part 1300

Biannual inventory



ARCOS reporting



Quota procurement (form 223)




EPA


Establishment Registration



Pesticide Application (premarket approval of new products under FIFRA)




AFT


Formula submission and approval (beverage grade and denatured formulas)