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ToxPlus Consulting

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Oak Brook, Illinois, US

About ToxPlus Consulting

With expertise in pharmacology, toxicology and medical writing, ToxPlus Consulting is your partner in developing preclinical study programs including preclinical study protocol development, study placement, study monitoring, reviewing and summarizing both GLP and non-GLP pre-clinical toxicology and safety pharmacology studies.

In addition, we have project management, medical writing and document preparation capabilities. We represent companies and associations during regulatory meetings with agencies and at various scientific venues.

We look forward to working with you!

Our Services (24)


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Toxicology Consulting

Price on request
Request a quote for more information about this service.

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Extractable and Leachable Testing

Price on request

Medical Device Testing

Safety assessments of extractables and leachables.


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Environmental Health and Safety Consulting

Price on request

Safety data sheet preparation.
Hazard band determination


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Educational Services

Price on request

Expert presentations on various scientific and regulatory topics including:
-GLP training
-Regulatory landscape of the IND, NDA process
-Various toxicology topics


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Scientific Manuscript Preparation

Price on request

Prepare and manage scientific manuscript preparation and submission.


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IND/NDA/BLA Submission

Investigational New Drug/New Drug Application Submission
Price on request

Pre-Clinical toxicology and pharmacology sections (written summaries and tabulated summaries) of INDs and NDAs


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Regulatory Document Preparation and Submission

Price on request

Pre-clinical toxicology and pharmacology sections (written summaries and tabulated summaries) of INDs and NDAs
Pre-IND meeting information packages
Investigator's brochures
Fast Track Applications
Orphan Drug Applications
Safety assessments of APIs, excipients, impurities, and extractables/leachables
Other regulatory documents


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Preclinical Study Design

Price on request

Pre-IND enabling study design and study management services.


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Technical Writing

Price on request

ToxPlus Consulting has expertise in medical/technical writing to meet the needs of clinents.

  • Pre-IND meeting information packages
  • Pre-clinical sections of INDs and NDAs
  • Investigator's brochures,
  • Orphan drug applications
    *Fast Track Applications
  • Safety assessments of APIs, excipients, impurities, and extractables/leachables
  • Other regulatory documents


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Project Management

Price on request
  • Toxicology study program development and management including, protocol design, study placement, study monitoring, and intrepretation of the data.
  • Chemical regulation and policy monitoring
  • Comment development for new regulations or changes to existing regulations
  • Attendance or representation at regulatory meetings with an overview oral and written report of the meeting
  • Scientific literature monitoring reports
  • Scientific conference attendance for intelligence gathering or data presentations
  • Research program development, monitoring and management
  • Literature reviews of available public data and proprietary data
  • Position/white papers
  • Manuscript drafting and submission for publication
  • Data compensation management


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Regulatory Affairs Consulting

Price on request

ToxPlus Consulting provides expertise in global regulations, preparation of regulatory documents and regulatory strategy to meet our clients' goals.

  • Regulatory strategy
  • Preparation for FDA meetings
  • Non-clinical sections of INDs/NDAs in legacy and eCTD format (using client's eCTD templates)
  • Investigator's brochure
  • FDA meeting requests and meeting packages
  • Representation at FDA or EPA meetings and preparation of meeting minutes
  • Orphan Drug Designations
  • Review of regulations and summary reports


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Toxicology

Price on request

Pre-Clincial Toxicology and Safety Pharmacology testing strategy development and program management.

ToxPlus Consulting provides toxicology expertise spanning small molecule drugs, biologics, vaccines and biosimilars. We work to develop the best approach to meet the clients' needs.

  • Pre-Clinical toxicology and safety pharmacology study management
    • Study identification and protocol design
    • Laboratory proposal management and assistance with laboratory selection including site visits
    • On-site study monitoring
    • Study data interpretation and study report review
  • Participation in meetings with regulatory authorities, attendance of regulatory meetings
  • Pre-clinical toxicology and pharmacology sections of INDs, NDAs
  • Data Gap Analysis
  • Safety assessments of APIs, excipients, impurities and extractables/leachables
    -Preparation of manuscripts


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Literature Review/Curation

Price on request

ToxPlus Consulting provides clients with literature reviews, literature monitoring reports and white papers.


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Animal Models and Studies

Price on request

Assistance with selecting animal models and selecting CROs who can conduct studies with select animal model.


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Editorial and Writing Services

Price on request

Editorial services and writing services available. Quotes upon request.


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Regulatory Affairs Services

Price on request
Request a quote for more information about this service.

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Pharmacology & Toxicology

Price on request

Pharmacology/Toxicology expert in data interpretation and study design for discovery or pre-clinical studies. Also, services include scientific writing in the area of pharmacology/toxicology.


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Scientific Manuscript Editing

Price on request

Scientific Manuscript editing services. Quotes upon request.


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Assay Development

Price on request
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Scientific Poster Design

Price on request
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GLP Auditing

Price on request

GLP Audit and Study Monitoring Services

-GLP Audits
-GLP Study Monitoring
-GLP Training


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Product Testing Services

Price on request

Product Testing Services


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Product Development, Testing, and Packaging

Price on request

Product Development, Testing, and Packaging Services


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Proofreading

Price on request
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