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QARA Pharma LLC

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Rockport, Massachusetts, US

About QARA Pharma LLC

Clinical and Regulatory documents are essential for drug development and management of approved drugs. QARA PHARMA was founded to fill an existing void, providing a superior document management system to help the pharmaceutical industry prepare and submit optimal documents. We have assembled a team of... Show more »

Clinical and Regulatory documents are essential for drug development and management of approved drugs. QARA PHARMA was founded to fill an existing void, providing a superior document management system to help the pharmaceutical industry prepare and submit optimal documents. We have assembled a team of experienced medical writers and physicians to facilitate your goal of creating clinical and regulatory reports that meet the highest standards in the industry.

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Diversity Certificates

Small business

Our Services (17)


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Regulatory Document Preparation and Submission

Price on request
  • IND, IDE, and CTA submissions
  • NDA, BLA, PMA, MAA, and PIP submissions
  • FDA and EMA briefing documents
  • Pre- and post-marketing annual and periodic safety reports (annual reports, DSURs, PSURs, PSRs, PBRERs)
  • Regulatory response
  • IND, IDE, and CTA submissions
  • NDA, BLA, PMA, MAA, and PIP submissions
  • FDA and EMA briefing documents
  • Pre- and post-marketing annual and periodic safety reports (annual reports, DSURs, PSURs, PSRs, PBRERs)
  • Regulatory response
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Regulatory Writing

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

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Medical Writing

Price on request
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Clinical Trial Design and Consulting

Price on request
  • Identify appropriate study endpoints, design, patient populations, and methodology
  • Conduct feasibility studies to determine appropriate and timely approach to conducting clinical studies
  • Prepare clinical study documents, including study protocols, investigator’s brochures, study procedure manuals, and all other associated documents required
  • Identify appropriate study endpoints, design, patient populations, and methodology
  • Conduct feasibility studies to determine appropriate and timely approach to conducting clinical studies
  • Prepare clinical study documents, including study protocols, investigator’s brochures, study procedure manuals, and all other associated documents required
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Assay Development

Price on request
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eCTD Services

Price on request
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Literature Review/Curation

Price on request
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IND/NDA/BLA Submission

Investigational New Drug/New Drug Application Submission
Price on request
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Clinical Development Strategy

Price on request
  • Manuscripts
  • Product monographs
  • White papers
  • Systematic literature reviews and meta-analyses
  • Manuscripts
  • Product monographs
  • White papers
  • Systematic literature reviews and meta-analyses
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Pharmaceutical Due Diligence

Price on request
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Process Consulting

Price on request

Process Consulting Services

Process Consulting Services

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Editorial and Writing Services

Price on request

Editorial Support Services

Editorial Support Services

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Marketing, Communication & Graphic Design Services

Price on request

Scientific Communication Services

Scientific Communication Services

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Clinical Trials, Consulting, and Management

Price on request

Clinical Trials, Consulting, and Management Services

Clinical Trials, Consulting, and Management Services

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Clinical Research

Price on request

Clinical Research Services

Clinical Research Services

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Regulatory Affairs Services

Price on request

Regulatory Affairs Services

Regulatory Affairs Services

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Project Management

Price on request

Project Management & Consulting Services

Project Management & Consulting Services

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Sonia Wheat

Medical Writer

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