atlregulatory.com atlregulatory.com

atlregulatory.com

Regulatory Affairs | Good Manufacturing Practices

ATL Regulatory is a premier regulatory affairs company providing good manufacturing practices for drug approvals.

http://www.atlregulatory.com/

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CONTACTS AT ATLREGULATORY.COM

ATL Regulatory Consulting, LLC

Anne Toland

221 Ca●●●●●●Avenue

Ben●●●lem , Pennsylvania, 19020

UNITED STATES

1215●●●●6888
1215●●●●8841
at●●●●●●@aol.com

View this contact

ATL Regulatory Consulting, LLC

Anne Toland

221 Ca●●●●●●Avenue

Ben●●●lem , Pennsylvania, 19020

UNITED STATES

1215●●●●6888
1215●●●●8841
at●●●●●●@aol.com

View this contact

ATL Regulatory Consulting, LLC

Anne Toland

221 Ca●●●●●●Avenue

Ben●●●lem , Pennsylvania, 19020

UNITED STATES

1215●●●●6888
1215●●●●8841
at●●●●●●@aol.com

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ATL Regulatory is a premier regulatory affairs company providing good manufacturing practices for drug approvals.
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Regulatory Affairs | Good Manufacturing Practices | atlregulatory.com Reviews

https://atlregulatory.com

ATL Regulatory is a premier regulatory affairs company providing good manufacturing practices for drug approvals.

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atlregulatory.com atlregulatory.com
1

Regulatory Compliance | Quality and Regulatory Compliance | ATL Regulatory Consulting

http://atlregulatory.com/services/quality-and-compliance-services

Quality and Compliance Services. Quality and Compliance Services. FDA-483, warning letter and consent decree remediation plans. On-site assistance during FDA inspections. Drug product recall support. Strategic planning for FDA facility approval. GMP and pre-approval inspection audits (FDA style mock inspections). Audits of third-party companies to support facility and product acquisition plans. Please complete the form below and we will contact you shortly. Quality and Compliance Services.

2

Pharmaceutical Consultants | Generic Drug Consultants | ATL Regulatory Consulting

http://atlregulatory.com/about

Quality and Compliance Services. ATL Regulatory Consulting was founded by Anne Toland who has over 25 years of pharmaceutical experience. Anne has a demonstrated knowledge of regulations and the NDA/ANDA submission process with a successful track record in obtaining drug product approvals. She has proven expertise in working effectively with the FDA, broad experience in handling PAI and GMP inspections and experience in Project Management and Regulatory Strategy. Quality and Compliance Services.

3

Pharmaceutical Consulting | FDA Registration | ATL Regulatory Consulting

http://atlregulatory.com/services

Quality and Compliance Services. US Agent services are offered for foreign companies who wish to submit product filings and obtain facility approval to market products in the U.S. As your liaison to the FDA, we will work effectively with your firm to facilitate filings and information requests from the FDA to help avoid delays with product approvals. To find out more about our services, please read below and click “read more” for additional information:. Our Project Managers will provide support and over...

4

U.S. Agent Services, | U.S. Agent Service | ATL Regulatory Consulting

http://atlregulatory.com/services/u-s-agent-services

Quality and Compliance Services. As your liaison to the FDA, we will work effectively with your firm to facilitate filings and information requests from the FDA to help avoid delays with product approvals. We will work in partnership with your firm to identify issues and help support a positive inspection outcome. Liaison with the FDA and clients to support timely approvals of submitted applications and help to navigate quickly through any developing issues. Facilitation of client meetings with the FDA.

5

FDA Approval Process | Regulatory Affairs Consulting | ATL Regulatory Consulting

http://atlregulatory.com/resources

Quality and Compliance Services. See below for some helpful pharmaceutical links. Http:/ www.fda.gov/AboutFDA/ReportsManualsForms/Forms/ListFormsNumerically/default.htm. Http:/ www.fdanews.com/. Http:/ www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/default.htm. Http:/ www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM339118.pdf. Http:/ www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#browse.

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