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Global Regulatory Service

FDA Regulatory Services
FDA is the abbreviation of Food and Drug Administration under a United States Department of Health and Human Services.
FDA covers regulating food, drugs, dietary supplements, cosmetics, medical devices and radiation emitting devices (including non-medical), biologics, and blood products for both human and animals.
FDA regulates products to ensure the safety of the American public and the effectiveness of marketed food, medical and cosmetic products. Regulations include, but are not limited to, outright ban, controlled distribution, and controlled marketing.

Registration and Notification service to FDA

1. 75 days Premarket Notification
2. 30 days Post Market Notification
3. Drug Master Files Establishment
4. Food Additive Petitions
5. Food Contract Notification (FCN)
6. Request for FDA Non-objection or opinion (advisory letter)
7. FDA liaison service
8. Procurement of FDA files under Freedom Information Act
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EPA Regulatory Services
The U.S. Environmental Protection Agency (EPA) is an agency of the federal government of the United States charged to regulate chemicals and protect human health by safeguarding the natural environment.
We offer regulatory services for EPA related business as stated below.

1. TSCA Pre-market Notification (PMN)
2. TSCA Low Volume Exemption (LVE)
3. TSCA Polymer Exemption
4. Notification of Import (NOC)
5. Bona fide request
6. Procurement of EPA files under the Freedom Information Act.
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European Regulatory Services
Through our partner OWS we provide European regulatory services such as controlled composting (CoCo) test and anaerobic high solid digestion tests for compost.
We also offer services of regulatory monitoring and current awareness on a global basis from our partners in the UK and EU countries.
We are currently in the process of expanding our business through out Europe.

1. European Regulatory Monitoring & current awareness 2.Biodegradable Materials and product testing services
3.Through our European partner laboratory - OWS