Biotech Research Group
Biotech Research Group (BRG) is a full-service regulatory and product development consulting firm specializing in FDA compliance, biologics, medical devices, and pharmaceuticals. They offer expert guidance for product development and clinical research.
Biotech Research Group (BRG) is a comprehensive regulatory and product development consulting firm with a global reach, serving clients in over 60 countries. They specialize in providing efficient and expeditious services for a wide range of products, including pharmaceuticals, medical devices, healthcare IT, and biologics. BRG is a leader in FDA regulations and compliance, offering expert support for various FDA submissions such as BLA, PMN, PMA, 510k, ANDA, NDA, and IND. Their services encompass the entire product development lifecycle, from initial research and clinical trials to post-market surveillance and adverse event reporting. BRG's team of experts possesses diverse therapeutic expertise and can assist with toxicology, pharmacokinetics, statistics, epidemiology, and pharmacovigilance. They tailor each product development or clinical research plan to meet specific client budgets and timelines. BRG is particularly adept at navigating complex FDA requirements, including those for biologics (BLA, vaccines, cellular & gene therapy) and medical devices (PMN, PMA, 510k). They also provide crucial support for pharmaceutical consulting, including ANDA, NDA, OTC, and IND applications. With a focus on quality management and streamlined processes, BRG ensures clients receive the best solutions for bringing their products to market safely and effectively.
About
**Who they are**
Biotech Research Group (BRG) is a full-service regulatory and product development consulting firm specializing in FDA compliance, biologics, medical devices, and pharmaceuticals. They offer expert guidance for product development and clinical research.
**Expertise & scope**
* FDA compliance for biologics, medical devices, and pharmaceuticals.
* Guidance for product development and clinical research.
* Expertise in FDA Adverse Event Reporting (AERS), including understanding its purposes, data structure, and reporting requirements.
* Assistance with FDA Establishment Registration for medical devices, dietary supplements, and cosmetics.
* Support for navigating the drug approval process, including laboratory testing and clinical trials.
* Experience in assisting foreign health departments with legislation and clients in over 60 countries with licensures and permitting.
**Reputation / proof points**
* Operates 24 hours a day, 7 days a week, all year long.
* Composed of doctors, researchers, toxicologists, epidemiologists, pathologists, and public health professionals in over 60 countries.
Biotech Research Group (BRG) is a full-service regulatory and product development consulting firm specializing in FDA compliance, biologics, medical devices, and pharmaceuticals. They offer expert guidance for product development and clinical research.
**Expertise & scope**
* FDA compliance for biologics, medical devices, and pharmaceuticals.
* Guidance for product development and clinical research.
* Expertise in FDA Adverse Event Reporting (AERS), including understanding its purposes, data structure, and reporting requirements.
* Assistance with FDA Establishment Registration for medical devices, dietary supplements, and cosmetics.
* Support for navigating the drug approval process, including laboratory testing and clinical trials.
* Experience in assisting foreign health departments with legislation and clients in over 60 countries with licensures and permitting.
**Reputation / proof points**
* Operates 24 hours a day, 7 days a week, all year long.
* Composed of doctors, researchers, toxicologists, epidemiologists, pathologists, and public health professionals in over 60 countries.
Additional information
Biotech Research Group emphasizes a global reach, serving clients in over 60 countries and employing professionals worldwide. They highlight their ability to address client needs around the clock, understanding the importance of timely collaboration. Their services extend to assisting with complex regulatory processes such as FDA Adverse Event Reporting (AERS) and FDA Establishment Registration, providing guidance on product safety, efficacy, and labeling. For product development, they support clients through laboratory testing and clinical trial phases, aiming for seamless integration into the US market.
Key Highlights
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Biotech Research Group (BRG) is a full-service regulatory and product development consulting firm.
Source
“Biotech Research Group (BRG) is a full-service regulatory and product development consulting firm specializing in FDA compliance, biologics, medical devices, and pharmaceuticals.”
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BRG experts work diligently to meet global client needs, operating 24 hours a day, 7 days a week, all year long.
Source
“Biotech Research Group (BRG) is open 24 hours a day, 7 days a week, all year long. BRG experts work diligently to meet our global client’s needs.”
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The firm's team includes professionals in over 60 countries, offering diverse expertise.
Source
“BRG consists of doctors, researchers, toxicologists, epidemiologists, pathologists, and public health professionals in over 60 countries, allowing us to serve the global community.”
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Specializes in FDA compliance, biologics, medical devices, and pharmaceuticals.
Source
“Biotech Research Group (BRG) is a full-service regulatory and product development consulting firm specializing in FDA compliance, biologics, medical devices, and pharmaceuticals.”
Certifications & Trust Signals
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Assists foreign health departments in writing legislation and works with clients in over 60 countries.
Source
“Christina has assisted foreign health departments in writing legislation and working with clients in over 60 countries with licensures and permitting.”
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Provides expertise in FDA Adverse Event Reporting (AERS) and FDA Establishment Registration.
Source
“The US FDA (Food and drug administration) is in charge of upholding patients and defending public health by guarantee the safety, security of medications, and efficacy.”
Buyer Snapshot
Best for
- Companies seeking FDA compliance consulting.
- Firms needing support with product development and clinical research.
- Businesses requiring assistance with adverse event reporting and establishment registration.
How engagement typically works
- Collaborative, client-focused approach.
- 24/7 availability for urgent needs.
- Global team of experts.
Typical deliverables
- Regulatory strategy and guidance.
- FDA submission support.
- Adverse event reporting documentation.
- Establishment registration filings.
Good to know
- Best when requiring specialized FDA regulatory expertise for biologics, medical devices, and pharmaceuticals.
HQ:
USA
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Annual Renewal Support:
Yes
Registration Support:
Yes
Inspection Support:
No
Emergency Contact24x7:
No
Annual Renewal Reminder:
No
Product Type:
devices
Additional us_agent_fda Details
Product Types
Biologics, Medical Devices, Pharmaceuticals, Drugs, Dietary Supplements, Cosmetics
Registration Support
Yes
Recall Support
Yes
Emergency Contact24x7
Yes
