ADPEN Laboratories

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ADPEN Laboratories featured in Tecan Journal

September 20, 2013 By Steven Perez

ADPEN Laboratories was featured in the Tecan Journal 3/2013 under the Mass Spectroscopy section. The article entitled “Meeting the demands of Mass Spectroscopy sample preparation” discusses ADPEN’s use of the Tecan Freedom Evo 100 robotic liquid handler. The Evo is used as part of ADPEN’s high throughput strategy for sample preparation. ADPEN ran many method trials to test the system’s robustness and validate the platform, successfully demonstrating that automation on the Freedom EVO was as good as, or better than, manual procedures.

Click on the image below to read the article or go Tecan Journal online to read the entire edition.

Filed Under: Agrosciences, ALL NEWS, Analytical Testing News & Updates | ADPEN Laboratories, Facility Highlights, Food Safety Links, Nutraceutical Links, Pharmaceutical Links

FDA Issues Final Rule on Clinical Investigator Disqualification

May 1, 2012 By Steven Perez

FDA has amended the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office, and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted. This rule is effective May 30, 2012.

To read the final rule visit this web link.

Filed Under: ALL NEWS, Analytical Testing News & Updates | ADPEN Laboratories, Nutraceutical Links, Pharmaceutical Links

SOCMA Issues Support for Generic-Drug User Fees

March 8, 2012 By Steven Perez

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), issued its support for the introduction of a House bill, the Generic Drug and Biosimilar User Fee Act (HR 3988), which SOCMA says will help to achieve parity between foreign and domestic firms.

In its statement, SOCMA said that up to 40% of all drugs Americans take are imported, and up to 80% of the APS in those drugs come from foreign sources. The Government Accountability Office says it would take FDA nine years to inspect all foreign facilities, according to the SOCMA statement.
[Read more…]

Filed Under: ALL NEWS, All Services, Analytical Testing News & Updates | ADPEN Laboratories, Pharmaceutical Links Tagged With: analysis, Analytical, FDA, pharmaceutical, products, Testing

FDA Issues Guidance Agenda for 2012

March 8, 2012 By Steven Perez

FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are about 50 such guidances planned. Below are a few highlights for the drug-manufacturing space.

In biopharmaceutics and biosimilarity:

• Food-Effect Bioavailability and Fed Bioequivalence Studies— Bioavailability and Bioequivalence Studies for Orally
Administered Drug Products Submitted in New Drug Applications General Consideration
• Scientific Considerations in Demonstrating Biosimilarity To a Reference Product (draft already issued)
• Quality Considerations in Demonstrating Biosimilarity To a Reference Protein Product (draft already issued)
• Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
(draft already issued)

In combination products:
• Development of Drugs in Combination
[Read more…]

Filed Under: ALL NEWS, All Services, Analytical Testing News & Updates | ADPEN Laboratories, Pharmaceutical Links Tagged With: analysis, Analytical, annual, FDA, GMP, guidance, pharmaceutical, Testing

Supplements Usage, Consumer Confidence at Highest Levels, According to CRN Annual Survey

November 14, 2011 By Steven Perez

Consumer confidence of supplements
US Consumers are using more supplements than ever before and consumer confidence is high.

U.S. consumers are not only using supplements more than ever before, they are also more confident than ever in the safety, quality, and efficacy of supplements. These results were presented as part of the Council for Responsible Nutrition’s (CRN; Washington, DC) 2011 annual Consumer Survey on Dietary Supplements, made public at CRN’s annual conference in October. (CRN has sponsored the survey since 2000.)

Supplements usage was high this year, topping the highest usage level previously recorded, in 2007. According to the 2011 results, 69% of U.S. adults reported using dietary supplements this year—beating out 2007’s high level of 68%. By contrast, usage in 2010 was reported to be 66%. [Read more…]

Filed Under: All Services, Analytical Testing News & Updates | ADPEN Laboratories, Nutraceutical Links, Pharmaceutical Links Tagged With: consumer confidence, pharmaceutical, products, supplements

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ISO/IEC 17025 ACCREDITED

ISO/IEC 17025 is a company level accreditation based on a standard published by the International Organization for Standardization (ISO) titled “General requirements for the competence of testing and calibration laboratories”. ISO/IEC 17025 is a general umbrella term used to refer to the specific standard; the current version of this standard is ISO/IEC 17025:2017. The standard contains two main sections: management requirements (primarily related to the operation and effectiveness of the quality management system within the laboratory) and technical requirements (primarily related to the competence of staff and calibration of equipment). The standard also gives requirements related to quality management such as document control and corrective action. This standard is the basis for accreditation from an accrediting body.

ADPEN has also been inspected by the US-EPA and US-FDA multiple times with no observations.

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ADPEN Laboratories, Inc.
11757 Central Parkway
Jacksonville, FL 32224 USA

Phone: 1.904.645.9169
Fax: (904) 641-8423
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