Pharmaceuticals

We can provide the following services for the pharmaceuticals and biopharmaceutical industries:

Preclinical Drug Development (Toxicological Assessment)

  • Derive health-based exposure limits

    • Calculation of Permitted Daily Exposure (PDE)

    • Calculation of Occupational exposure limit (OEL)

  • Toxicological evaluation of Degradants, Impurities, Residual Solvents, and Excipients

  • Execution of nonclinical safety assessment strategies across the following therapeutic areas

    • Oncology

    • Cardiovascular and Metabolic disorders

    • CNS disorders

  • Development of safety-related issue mitigation and resolution plan

  • Facilitate study placement:

    • Identify Contract Research Organization

    • Coordinate design (protocol development), monitor, and report preparation for toxicology and safety pharmacology studies

  • Types of toxicology studies supported

    • General toxicology

    • Genetic toxicity

    • Developmental and Reproductive toxicity

    • Carcinogenicity

  • Help derive the maximum recommended starting dose (MRSD)

Scientific Writing

  • Expertise in various types of scientific writing, including:

    • eCTD submissions

    • Preparation of Pre-IND Briefing Packet

    • Preparation of preclinical documents for regulatory submission (IND/CTA)

    • Clinical study reports

    • Scientific publications

    • Abstract submission

  • Editing and proofreading services for existing documents to improve clarity and readability

Digital illustration of a DNA strand made of blue and white capsules next to a hexagonal medical icons graphic.

Frequently Asked Questions

  • Toxicology evaluates potential health impacts of pharmaceutical compounds, guiding safe formulation, handling, and regulatory compliance. From preclinical in vitro and in vivo studies to clinical trials, toxicology ensures drugs are both effective and safe for human use, supporting informed dosing and minimizing adverse effects.

  • A Pre-IND Briefing Packet, or Briefing Document, compiles clinical study synopsis, in vitro and early in vivo toxicology results, safety rationale, assay descriptions, and the development plan. It ensures that study design, safety data, and proposed clinical plans are clearly presented and communicated, facilitating early alignment with regulators.

  • A regulatory dossier compiles scientific, technical, safety, and administrative data for drug approval, often in CTD (Common Technical Document) or eCTD format. It allows regulators to assess a medicine’s quality, safety, and efficacy. SciQra supports dossier preparation, including content for CTD Modules 2–5, helping streamline global regulatory submissions.

  • SciQra conducts toxicological assessments of degradants, impurities, residual solvents, and excipients. We implement nonclinical safety assessment strategies across therapeutic areas, including oncology, cardiovascular, metabolic, and CNS disorders—and assist in deriving the Maximum Recommended Starting Dose (MRSD) and developing mitigation plans for safety-related issues.

  • We facilitate study placement by identifying suitable Contract Research Organizations (CROs), coordinating protocol development, and preparing comprehensive toxicology and safety pharmacology reports - ensuring studies meet regulatory expectations and support robust safety evaluations.