Other Regulatory Services
JAD Regulatory Consulting Inc. will assist you in identifying regulatory and legal requirements for your products or advertising and help you comply with the requirements before a case is initiated against your company or your products.
We invite you to take advantage of our no-nonsense hands on approach to achieving compliance with FDA regulations and requirements. JAD is committed to assist our clients in being compliant with U.S. FDA regulations.
Below you will find a few examples of the types of services JAD Consulting is able to provide.
Consulting services might include:
- Regulatory label reviews for foods, cosmetics, dietary supplements
- Compliance with current good manufacturing practices
- Assisting in designing label or labeling claims for foods, dietary supplements in accordance with FDA requirements
- Assisting in complying with registration of your foreign facility
- Assisting with implementing required steps to bring products or manufacturing warehousing into compliance with FDA Regulation
- Assistance in obtaining and using private laboratory analysis for release of FDA refused goods or FDA Import Alert
- Evaluation, review or analysis of evidence relied upon by the government to
- initiate an administrative action (FDA detention, refusal, debarment, warning letter)
- support a civil seizure action (under FDA or Customs authority)
- Provide advice regarding legal and regulatory requirements of the USFDA
- Advise companies regarding required steps to bring articles, processes, companies, or records into compliance with regulatory and legal requirements
- Provide advice in administrative actions, such as:
- Responding to FD-483s
- Responding to FDA Warning or Untitled Letters or USDA notices of non-compliance
- Responding to Notices of detention or other administrative actions
- State embargoes
- Appealing FDA refusals seeking release of the refused cargo
- Regulatory meetings with FDA Center Compliance or FDA Office of Enforcement or FDA District officials
- Product Label Reviews/Revisions
- Marketing (Labeling) Reviews/Revisions
- Registration of your facility
- US Agent Services
- Prior Notice service
- Pre-FDA Inspection
- HACCP services
- FDA Sampling concerns
- Resolving FDA Detentions
- Rescinding FDA Refusals
- Resolving Import Alerts
- Recall Support
- Correspondence with Government
- Mock FDA inspections
We can perform a mock FDA Inspection of your facility; recommend steps to bring your company into compliance with FDA regulations.
Programs will be developed to suit your specific situation. We can implement the programs and provide training or training materials to help you.
Our company mission is to assist Foreign & Domestic manufacturers in developing and implementing cost-effective regulatory and business strategies to meet U.S. FDA regulations and requirements for their specific products.
JAD will strive to establish an effective working relationship between our client and the U.S. Food and Drug Administration and managing an approved manufacturing facility. The founder of the company brings a wealth of knowledge to assist and provide the right guidance too small to mid-size processors, importers, exporters, distribution centers, restaurants, institutions and retailers who do not completely understand the proper guidelines within the standards of the FDA.
JAD Regulatory Consulting Inc. will provide the best service it can provide, by utilizing the expertise the founder and our subject matter experts have aquired within our careers with cost-effective and practical solutions for today’s regulatory challenges.