A drug is any substance (except food and water) that when inhaled, injected, smoked, consumed, absorbed via a patch on the skin, or dissolved under the tongue causes a physiological change in the body. Drugs can either be synthesized by a chemistry reaction, or semi-synthesized from biological sources, which in that case are known as biologics.

In the US, as well as in other countries, drugs and biologics must be licensed to be placed on the market. Not only do products need to show proof of safety and efficacy, but it must maintain cGMP compliance even after its distribution and use by patients.

​

Services offered by Prologos Law:

• FDA Administrative Proceedings

• Form 483, Warning Letters and Consent Decree

• Action Indicated Notices

• IRB participation and auditing

• US Customs Product Entry

• Product Exports

• Type A, B, C Meetings

• CRO / CMO Agreements

• Clinical Trial Agreements

• Informed Consents

• Case Reports Forms

• GxP Training for Sponsors, PIs and CROs

• Good Laboratory Practices (GLPs)

• Good Clinical Practices (GCPs)

• Current Good Manufacturing Practices (cGMPs)

• Regulatory Strategy

• Orphan Drugs

​