๐ง๐ผ๐ฝ ๐ฑ ๐๐ถ๐ด๐ถ๐๐ฎ๐น ๐๐ฒ๐ฎ๐น๐๐ต ๐๐ป๐ป๐ผ๐๐ฎ๐๐ถ๐ผ๐ป๐: ๐ช๐ต๐ ๐ข๐ป๐น๐ ๐ฎ๐ฌ% ๐ผ๐ณ ๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐ง๐ฟ๐ถ๐ฎ๐น๐ ๐ฆ๐๐ฐ๐ฐ๐ฒ๐ฒ๐ฑ https://lnkd.in/easTP4Ni ๐ง๐ฎ๐น๐ธ ๐๐ถ๐๐ต ๐ฎ๐ป ๐ฒ๐ ๐ฝ๐ฒ๐ฟ๐ ๐https://lnkd.in/e52sdG3P Contact BIOBOSTON CONSULTING today or visit our website at https://lnkd.in/dfarwCK2 to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda
BIOBOSTON CONSULTING
Business Consulting and Services
Boston, Massachusetts 2,900 followers
Helping the Life Sciences Industry from Pre-Clinical to Commercial. ๐กGet Started with the link below ๐
About us
BioBoston Consulting, headquartered in Boston, is a Life Science consulting firm that provides strategic regulatory, quality, clinical and organizational support to pharmaceutical, biotechnology, and medical device organizations from the early stages of product development through to commercialization.
- Website
-
https://www.biobostonconsulting.com
External link for BIOBOSTON CONSULTING
- Industry
- Business Consulting and Services
- Company size
- 11-50 employees
- Headquarters
- Boston, Massachusetts
- Type
- Privately Held
- Specialties
- QMS Implementation, Quality Assurance & Regulatory Compliance, Inspection Readiness, Gap Assessment & Remediation, Internal Audits, Supplier Audits, Supplier Management, Qualification & Validation, Regulatory Affairs, Clinical Affairs, Technology Transfer, Risk Management, Project Management, Training, CSV, Clinical Trials, Regulatory Submissions, IND/IDE/NDA/BLA/PMA, IVDR, MDSAP, FDA Inspection Readiness, CMO and CRO Management, and Mock FDA Inspection
Locations
-
Primary
75 State St
100
Boston, Massachusetts 02109, US
Employees at BIOBOSTON CONSULTING
-
Abhay Gupta
Freelance Consultant (Pharmaceutical & Regulatory Sciences)
-
Beatriz Rodriguez Vera
Industrial Microbiology | Quality Assurance | R&D | Consulting | Women Mentoring | GxP | ABIHPEC
-
Manjusha Kadiyala
Pharmaceutical Consultant
-
Angel Estrada, Ph.D. MSQA
Global Expert in Life Sciences Quality & Regulatory
Updates
-
๐๐ฎ๐ซ๐ฉ๐จ๐ฌ๐ ๐๐ง๐ ๐๐จ๐ง๐ญ๐๐ง๐ญ ๐จ๐ ๐๐ฌ๐-๐๐๐ฅ๐๐ญ๐๐ ๐๐ข๐ฌ๐ค ๐๐ง๐๐ฅ๐ฒ๐ฌ๐๐ฌ ๐๐จ๐ซ ๐๐ซ๐ฎ๐ ๐ฌ, ๐๐ข๐จ๐ฅ๐จ๐ ๐ข๐๐๐ฅ ๐๐ซ๐จ๐๐ฎ๐๐ญ๐ฌ, ๐๐ง๐ ๐๐จ๐ฆ๐๐ข๐ง๐๐ญ๐ข๐จ๐ง ๐๐ซ๐จ๐๐ฎ๐๐ญ๐ฌ ๐ ๐ฎ๐ธ๐ฒ ๐ฎ๐ป ๐ฎ๐ฝ๐ฝ๐ผ๐ถ๐ป๐๐บ๐ฒ๐ป๐ ๐https://lnkd.in/e52sdG3P ๐๐ผ๐๐ป๐น๐ผ๐ฎ๐ฑ ๐๐ต๐ถ๐ ๐ด๐๐ถ๐ฑ๐ฎ๐ป๐ฐ๐ฒ ๐ต๐ฒ๐ฟ๐ฒ: https://lnkd.in/ekHs47tJ This guidance provides an in-depth look on the purpose and content of a use-related risk analysis (URRA) and how a URRA, along with other information, can be used to determine human factors (HF) data needs during product development and to support a marketing application. The URRA should encompass: โถ A detailed list of all tasks required for product use. โถ Identification of potential use errors and associated harms for each task. โถ Determination of whether each task is critical. โถ Risk controls implemented in the user interface design to mitigate use errors. โถ Evaluation methods used or planned to assess the effectiveness of these risk controls. Sponsors should begin developing URRA early in the product development process, then use and update it throughout the product lifecycle, for example, as the design changes, or as new risks become apparent during development. Sponsors should consider all the intended uses, potential users, and likely use environments when developing the URRA. In each case, the product design, user tasks, and the potential risks and harms associated with its use may be impacted. For more information on human factors and use-related risk, sponsors should refer to the FDA and industry guidance Applying Human Factors and Usability Engineering to Medical Devices. Contact BIOBOSTON CONSULTING today or visit our website at https://lnkd.in/dfarwCK2 to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda
Quality Assurance & Regulatory Compliance | BioBoston Consulting
biobostonconsulting.com
-
๐ง๐ผ๐ฝ ๐ฏ ๐ ๐ฎ๐ฟ๐ธ๐ฒ๐ ๐๐ฐ๐ฐ๐ฒ๐๐ ๐๐ต๐ฎ๐น๐น๐ฒ๐ป๐ด๐ฒ๐: ๐ข๐ป๐น๐ ๐ญ๐ฑ% ๐ผ๐ณ ๐๐บ๐ฒ๐ฟ๐ด๐ถ๐ป๐ด ๐ง๐ต๐ฒ๐ฟ๐ฎ๐ฝ๐ถ๐ฒ๐ ๐ฆ๐๐ฐ๐ฐ๐ฒ๐ฒ๐ฑ ๐ ๐ผ๐ฟ๐ฒ ๐ถ๐ป๐ณ๐ผ๐ฟ๐บ๐ฎ๐๐ถ๐ผ๐ป:๐https://lnkd.in/e52sdG3P Contact BIOBOSTON CONSULTING today or visit our website to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda #market #therapies
-
๐ง๐ผ๐ฝ ๐ฏ ๐ ๐ฎ๐ฟ๐ธ๐ฒ๐ ๐๐ฐ๐ฐ๐ฒ๐๐ ๐๐ต๐ฎ๐น๐น๐ฒ๐ป๐ด๐ฒ๐: ๐ข๐ป๐น๐ ๐ญ๐ฑ% ๐ผ๐ณ ๐๐บ๐ฒ๐ฟ๐ด๐ถ๐ป๐ด ๐ง๐ต๐ฒ๐ฟ๐ฎ๐ฝ๐ถ๐ฒ๐ ๐ฆ๐๐ฐ๐ฐ๐ฒ๐ฒ๐ฑ https://lnkd.in/eRxJ3rC5 ๐๐ผ๐ป๐๐ฎ๐ฐ๐ ๐จ๐ ๐https://lnkd.in/e52sdG3P Contact BIOBOSTON CONSULTING today or visit our website at https://lnkd.in/dfarwCK2 to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda
Top 3 Market Access Challenges: Only 15% of Emerging Therapies Succeed
BIOBOSTON CONSULTING on LinkedIn
-
๐ข New Draft Guidance Alert from the FDA! ๐ขHow do you think this will shape the future of clinical trials? ๐ Your input is invaluable! Share your thoughts and let's engage in a meaningful discussion! ๐ฌ The FDA has issued a new draft guidance detailing the form, content, and manner of Diversity Action Plans. This includes: Applicable medical products and clinical studies requiring a Diversity Action Plan. Timing and process for submitting these plans. Criteria and process for evaluating waiver requests from the requirement to submit a Diversity Action Plan. This guidance replaces the previous draft entitled โDiversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trialsโ published on April 14, 2022. It is issued as mandated under section 3602 of FDORA, addressing the format and content of diversity action plans required by sections 505(z) and 520(g) of the FD&C Act. ๐ Your input is invaluable! How do you think this will shape the future of clinical trials? Share your thoughts and let's engage in a meaningful discussion! ๐ฌ #FDA #DiversityActionPlans #ClinicalTrials #HealthcareInnovation #IndustryNews #Pharmaceuticals #biotech #biotechnology
-
๐ง๐ผ๐ฝ ๐ฑ ๐๐ต๐ฎ๐น๐น๐ฒ๐ป๐ด๐ฒ๐ ๐ถ๐ป ๐๐ฟ๐๐ด ๐ฅ๐ฒ๐ฝ๐๐ฟ๐ฝ๐ผ๐๐ถ๐ป๐ด: ๐ช๐ต๐ ๐ข๐ป๐น๐ ๐ญ๐ฑ% ๐ผ๐ณ ๐ง๐ฟ๐ถ๐ฎ๐น๐ ๐ฆ๐๐ฐ๐ฐ๐ฒ๐ฒ๐ฑ https://lnkd.in/ebSMw7-r ๐ฆ๐ฐ๐ต๐ฒ๐ฑ๐๐น๐ฒ ๐ฎ ๐ฐ๐ผ๐ป๐๐๐น๐๐ฎ๐๐ถ๐ผ๐ป๐https://lnkd.in/e52sdG3P Contact BIOBOSTON CONSULTING today or visit our website at https://lnkd.in/dfarwCK2 to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda
Top 5 Challenges in Drug Repurposing: Why Only 15% of Trials Succeed
BIOBOSTON CONSULTING on LinkedIn
-
๐๐๐ ๐๐ฝ๐ฝ๐ฟ๐ผ๐๐ฒ๐ ๐๐น๐ถ ๐๐ถ๐น๐น๐โ๐ ๐๐ผ๐ป๐ฎ๐ป๐ฒ๐บ๐ฏ ๐๐ผ ๐ง๐ฟ๐ฒ๐ฎ๐ ๐๐น๐๐ต๐ฒ๐ถ๐บ๐ฒ๐ฟโ๐ ๐๐ถ๐๐ฒ๐ฎ๐๐ฒ ๐ง๐ฎ๐น๐ธ ๐๐ถ๐๐ต ๐ฎ๐ป ๐ฒ๐ ๐ฝ๐ฒ๐ฟ๐ ๐https://lnkd.in/e52sdG3P ๐น The FDA has approved Eli Lilly's donanemab, an anti-amyloid antibody marketed as Kisunla, making it the third drug approved to modify the course of Alzheimerโs disease. This approval follows the previously approved anti-amyloid antibodies, Biogen and Eisaiโs Aduhelm, and Leqembi, which has been commercially successful. The FDA's decision, supported by a favorable advisory committee vote, underscores the positive stance on donanemab despite concerns over trial design and safety, particularly amyloid-related imaging abnormalities (ARIA). ๐นExperts anticipate that donanemabโs approval will benefit the broader market, including Leqembi, by enhancing diagnostic and treatment options for Alzheimerโs disease. Contact BIOBOSTON CONSULTING today or visit our website at https://lnkd.in/dfarwCK2 to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda
Quality Assurance & Regulatory Compliance | BioBoston Consulting
biobostonconsulting.com
-
๐ฃ๐ฟ๐ถ๐๐ฎ๐ฐ๐ ๐๐. ๐ข๐ฝ๐ฒ๐ป๐ป๐ฒ๐๐: ๐ง๐ต๐ฒ ๐๐ฎ๐๐ฎ ๐๐ถ๐น๐ฒ๐บ๐บ๐ฎ ๐๐ผ๐ป๐๐ฎ๐ฐ๐ ๐จ๐ ๐https://lnkd.in/e52sdG3P Contact BIOBOSTON CONSULTING today or visit our website at https://lnkd.in/dfarwCK2 to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda
-
๐ง๐ผ๐ฝ ๐ฑ ๐๐น๐ฎ๐ฟ๐บ๐ถ๐ป๐ด ๐ฆ๐๐ฎ๐๐ ๐ฌ๐ผ๐ ๐ก๐ฒ๐ฒ๐ฑ ๐๐ผ ๐๐ป๐ผ๐ ๐๐ฏ๐ผ๐๐ ๐ฃ๐ฟ๐ถ๐๐ฎ๐ฐ๐ ๐๐. ๐ข๐ฝ๐ฒ๐ป๐ป๐ฒ๐๐ https://lnkd.in/eH_VVmvR ๐ง๐ฎ๐น๐ธ ๐๐ถ๐๐ต ๐ฎ๐ป ๐ฒ๐ ๐ฝ๐ฒ๐ฟ๐ ๐https://lnkd.in/e52sdG3P Contact BIOBOSTON CONSULTING today or visit our website to learn more about how we can support your organization. https://lnkd.in/dfarwCK2 #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda
Top 5 Alarming Stats You Need to Know About Privacy vs. Openness
BIOBOSTON CONSULTING on LinkedIn