Terms of Services

While browsing our website or opting for any service from Pragmatic Compliance LLC, the following general terms are applicable.

Confidentiality and Privacy Policy

Customer confidentiality is a top priority for Pragmatic. Pragmatic will not intentionally disclose any confidential information to third parties unless mutually agreed by Pragmatic and the Company.

Pragmatic may contact their customers or the interested parties for promotion of their services and updates on regulatory information. Users have the right to unsubscribe from the services and Pragmatic will act promptly on such request.

Users browsing our website must not copy, download or store any content or information appearing on the website.

While collecting forms and customer data, Pragmatic may store the IP address from where the data in entered.

While Pragmatic strives to employ the best security polices, it remains the responsibility of the customer to secure the transmission of their information.

Services

Pragmatic offers services across the globe for Drug, Food, Medical Device and Cosmetic companies. It remains the responsibility of the client company to comply with all local laws and regulations while signing service agreements with Pragmatic and for financial transactions.

Pragmatic is a private consulting firm and not associated with the FDA in any manner.

While offering regulatory services, Pragmatic takes the utmost care to provide the right guidance that considers the client Company’s welfare and that is based on Pragmatic’s knowledge and experience. Consulting services will not be held legally binding.

The standard language of communication used by Pragmatic is English. However, Pragmatic offers multilingual email support using machine translated language. It remains the client Company’s responsibility to verify the information.

For any regulatory submission – including SPL, ANDA, NDA, Registration, Listing or any regulatory information submitted by Pragmatic on behalf of the client Company – it remains the client Company’s responsibility to assure the technical correctness, accuracy and truthfulness of the information provided.

As standard practice, Pragmatic sends notification for the registration renewal of drug, medical device and food facilities and offers services for registration if such services are mutually agreed between Pragmatic and the client Company, However, it remains the client Company’s responsibility to keep their registration current and active, either by contacting Pragmatic for any such actions or directly by themselves.

The FDA does not offer Certification for Medical device, food, drug or any such registration including drug listing. Pragmatic can offer a confirmation certification upon request from their customer. This would be for reference purposes only.

Pragmatic has the right to involve their associates for consulting or any other regulatory business.

In case of non-payment of any offered services, Pragmatic has the right to revoke the services and will not be responsible for any losses or consequences caused by such revocation of services.

Neither party to this contract shall be held responsible for breach of contract caused by an act of God, insurrection, civil war, military or local emergency, or by any act or failure to act by the U.S. Food and Drug Administration.

Communication

Pragmatic relies on email communication. All the important communication – including regulatory actions from the FDA, US Agent renewal, and Registration renewal – are notified through email. The primary communication language will be English.

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