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