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Jimenez BBA LLC
Jimenez BBA LLC is listed as a small consultant research supplier in the Scientist.com network, with 1 site in 1 country.
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Sites
1
Countries
1
Services
What this research supplier says it provides, as listed in the Scientist.com network.
Type of company: Small consultant
Chemical and Compound Analysis
- Chemical Stability Measure the stability of small molecules in solution.
Chemistry, Manufacturing and Controls (CMC)
- API and drug product storage and release API and drug product storage and release
- API manufacturing process development, tech transfer and validation API manufacturing process development, tech transfer and validation
- Chemistry, Manufacturing and Controls (CMC) Request Chemistry, Manufacturing and Controls services
- Forced Degradation Run light, heat, humidity, acid hydrolysis and oxidation tests to evaluate substance degradation.
- ICH-compliant stability testing Perform ICH-compliant stability testing
Clinical Consulting
- IND Writing Consulting Consulting for an Investigational New Drug Application
- Regulatory Consulting Ensure that each product or device complies with all FDA rules and regulations.
Clinical Trials
- Regulatory Affairs Consulting Receive assistance ensuring compliance with regulatory requirements.
Discovery Chemistry
- Leachable and extractable testing Leachable and extractable testing
Drug Development
- Chemistry, Manufacturing and Controls (CMC) Consulting Consultant services related to the development of pharmaceutical and biopharmaceutical drug products that are consistently effective, safe and high quality for consumers.
- Consulting Services Work with consultants who provide expert advice in various areas of research and technology.
- Large Molecule Drug Development Consulting Develop large molecule drugs and complex biologics that have a therapeutic effect.
Show all 19 services
Medical Communications
- Publication Writing Create further publication documents. Investigational device exemptions (IDEs) BLAs, MAA, PMA, eCTDs, informed consents, CMC and manufacturing reports, orphan drug designations (ODD), briefing books.
- Regulatory Submissions and Compliance Draft, format, and submit documents to Pharmaceutical approval agencies according to documentation and guidelines. This includes documents such as NDAs, INDs, SUSARs, AE reporting, RMPs, and PSURS.
Pharmacovigilance
- Risk-Based Monitoring Planning and Implementation Risk-based monitoring planning and implementation involve creating and executing a strategy that prioritizes monitoring resources based on the potential risks to patient safety and data quality in clinical trials...
REACH Services
- Dossier Prep. and Consultancy Assistance with creation of a regulatory document that contains all the Clinical, non-clinical, and CMC information of a pharmaceutical product to be approved, registered, or marketed within a specific country.
Regulatory Affairs
- Regulatory Submission Documents Request services related to the submission and writing of New Drug Applications (NDA), Investigational New Drugs (INDs), and Investigator Brochures (IB) to the FDA and other regulatory bodies.
- Risk Evaluation & Mitigation Strategy (REMS) Evidence required by FDA to support the benefit of treatment outweighs the risks. Purpose of REMS is to prevent, monitor, and manage serious risk by informing, educating, and reinforcing actions to reduce frequency...
Where it operates
Sites by country, with the cities in each.
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United States 1 site
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