8,327 Companies

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Spotfolio tracks over one million companies in technology industries.

There are 8,327 companies in the field of Biotechnology on spotfolio that produce or deliver products, that utilize or research technologies or that are otherwise engaged in topics such as Clinical, Drug, Patients, FDA, Research, Disease, Medical, Treatment .

Start-ups (719)

Early-stage companies (1,756)

Established companies (4,995)

The majority of these companies is located in the following countries.

United States (5,072)

United Kingdom (394)

Canada (306)

China (249)

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IHL Consulting Group

established

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SERVICES ABOUT HOME SERVICES IHL Consulting Group, Inc. provides FDA Consulting services to FDA Regulated Industries domestically in the United States and Internationally ...

Pharmaceutical, Medical Device, and Biologics industries. Our FDA Consultants and former (ex-)FDA Investigators are ready to provide the following services ...

regulatory success: International Specific Services: • Assistance with FDA Registration and Product Listings • US Agent Services and Representation • ...

Services (Domestic and International): • Executive Counseling on FDA Compliance Matters • FDA Registration and Product Listings • Quality System Assessments ...

Vendor Audits and Qualification • FDA 483/Warning Letter Responses • FDA Inspection Preparation and Training • Liaison with FDA District and Headquarter Offices

Consulting Group, Inc. has operated as a professional group of FDA Consultants to provide FDA compliance advice to the pharmaceutical, medical device, and ...

and around the world. Our FDA Consultants have over 100 years of Regulatory Compliance experience and consist of former (ex-) FDA Investigators/ Inspectors ...

regulatory environment, FDA compliance and a sound Quality System and infrastructure are strategic keys to the success of any FDA regulated industry. With ...

stake, you need sound advice from experienced and FDA Consultants and professionals you can trust - FDA Consultants who will help clients minimize risk and ...

Whether its Mock GMP, Quality System, or Pre-Approval Audits; or targeted FDA Training and Quality Assurance support, IHL commits to you, our clients and ...

partners, to always seek solutions that will ensure your best chances of FDA success - and solutions that ensure you make the right critical decisions

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result: 3 minutes; Shelf life: 2 years; Storage: 15 to 30°C (59 to 86°F) FDA cleared, CLIA waived, OTC, CE 10111 Midstream (QuikResponse) Urine Pregnancy ...

result: 3 minutes; Shelf life: 2 years; Storage: 15 to 30°C (59 to 86°F) FDA cleared, CLIA waived, OTC, CE 10110 Midstream I Urine Pregnancy Test Sensitivity: ...

result: 3 minutes; Shelf life: 2 years; Storage: 15 to 30°C (59 to 86°F) FDA cleared, CLIA waived, OTC, CE 10120 Midstream II Urine Pregnancy Test Sensitivity: ...

result: 3 minutes; Shelf life: 2 years; Storage: 15 to 30°C (59 to 86°F) FDA cleared, CLIA waived, OTC, CE 7010KT Urine Pregnancy Test (Cassette) – 6 Days ...

result: 3 minutes; Shelf life: 2 years; Storage: 15 to 30°C (59 to 86°F) FDA cleared, CLIA waived, OTC, CE 9010 Urine Pregnancy Test (DipStick) Sensitivity: ...

result: 3 minutes; Shelf life: 2 years; Storage: 15 to 30°C (59 to 86°F) FDA cleared, CLIA waived, OTC, CE 7010KS Serum/Urine Comb Pregnancy Test (5 mm

result: 2-5 minutes; Shelf life: 2 years; Storage: 15 to 30°C (59 to 86°F) FDA exempt, OTC, CE 10420 LH Ovulation Test (Cassette) Cut-off value: 30 mIU/mL; ...

result: 2-5 minutes; Shelf life: 2 years; Storage: 15 to 30°C (59 to 86°F) FDA exempt, OTC, CE 10460 LH Midstream I Ovulation Test Cut-off value: 30 mIU/mL; ...

result: 2-5 minutes; Shelf life: 2 years; Storage: 15 to 30°C (59 to 86°F) FDA exempt, CLIA waived, OTC, CE 10470 LH Midstream II Ovulation Test Cut-off ...

result: 2-5 minutes; Shelf life: 2 years; Storage: 15 to 30°C (59 to 86°F) FDA exempt, CLIA waived, OTC, CE 10480 LH Digital Multiple Use Ovulation Test ...

result: 2-5 minutes; Shelf life: 18 months; Storage: 15 to 30°C (59 to 86°F) FDA exempt, OTC, CE 10481 LH Digital Multiple Use Ovulation Numeric Test Each ...

result: 2-5 minutes; Shelf life: 18 months; Storage: 15 to 30°C (59 to 86°F) FDA exempt, OTC, CE We are here to help with your needs: How to Order © 2021

SCA Pharmaceuticals

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medications… Read More→ How to Properly Decipher an FDA Form 483 How to Properly Decipher an FDA Form 483 - October 8, 2018 - Webinar In your role, ...

request each Form 483 and decipher the unnecessarily complex jargon of the FDA. Mosaic by design, it… Read More→ The Advantages of 503B Compounding The ...

19, 2020 Categories - 503B Outsourcing (5) - COVID-19 (5) - Events (3) - FDA (3) - News (13) - Outsourcing (1) - USP (1) - Webinar (5) Tags 503B acetaminophen ...

acetaminophen cGMP Communication COVID-19 COVID Response DoseID Facilities facility FDA HCP Health Connect Partners hospital pharmacies Inspections Kit Check Matt

of FDA Registered 503B Outsourcing Facilities Review a searchable list of Current and Resolved Drug Shortages and Discontinuations Reported to FDA SCA

HyperbaricLink

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Topics - Key Points - FDA Clearance - UHMS Approval - Off-Label Treatment Key Points - The US Food and Drug Administration (FDA) is responsible for protecting ...

products. - Federal law authorizes the FDA to regulate the marketing of hyperbaric chambers as Class II medical devices. - FDA regulations require valid scientific ...

diseases and conditions) it will be used to treat. - Applications to the FDA by manufacturers of hard-walled hyperbaric chambers reference the Report of ...

American Society of Mechanical Engineers - National Fire Protection Association FDA Clearance Regulation of medical device manufacturers is the responsibility ...

manufacturer must demonstrate that the device is labeled in accordance with FDA labeling regulations. Labeling is defined to include virtually all advertising ...

manufacturers. To maintain clearance, manufacturers must also comply with FDA requirements governing manufacturing processes and documentation. Other federal

Home - Hyperbaric Chamber Manufacturers Hyperbaric Chamber Manufacturers FDA-Cleared Chambers Hospitals, outpatient facilities, and independent hyperbaric ...

manufacturers of hyperbaric chambers The following manufacturers have not received FDA clearance to market their products in the US. Their chambers conform to European ...

supplies and monitoring and control systems. These manufacturers have received FDA clearance to market their products to treat the diseases and conditions approved ...

UK  Important safety information The US Food and Drug Administration (FDA) classifies hyperbaric chambers as Class II medical devices. US federal regulations ...

Inflatable devices, so-called “mild hyperbaric“ chambers, are not cleared by the FDA for treatment of any of the medical conditions approved by the Undersea and

BioSapien BioSapien Inc

start-up

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tumor cells and the hard-to-reach tumor sites by delivering the cancer drugs (FDA approved APIs; gemcitabine and 5-FU[FOLFIRI]) directly to the site of the

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