Gad Consulting Services
Gad Consulting Services is an internationally recognized toxicology and drug development consulting practice serving primarily the pharmaceutical and medical device industries. Since 1993, the company has been providing technical and regulatory support in preclinical and early clinical evaluation, safety assessment, and risk assessment, with a focus on new product development and existing product support. The team has over 47 years of combined experience and offers a full range of services in toxicology, risk assessment, regulatory guidance, and more, with a commitment to timely, quality, and cost-effective services.
Industries
Nr. of Employees
small (1-50)
Gad Consulting Services
Raleigh, North Carolina, United States, North America
Products
Publications (books, chapters, peer-reviewed papers)
Authored books, book chapters, and peer-reviewed articles covering regulatory toxicology, nonclinical safety, drug formulations, biomarkers, and device safety.
Publications (books, chapters, peer-reviewed papers)
Authored books, book chapters, and peer-reviewed articles covering regulatory toxicology, nonclinical safety, drug formulations, biomarkers, and device safety.
Services
Advisory services covering preclinical and early clinical safety assessment, study strategy, and product safety evaluation for drugs, devices, and combination products.
Toxicological risk assessments including impurity qualification, leachables and extractables evaluation, and derivation of exposure-based limits.
Conduct of GLP analytical and preclinical audits, GMP manufacturing audits, and compliance assessments for domestic and international operations.
Preparation of regulatory documentation and support for interactions with regulatory authorities, including IND, NDA, ANDA, 510(k), IDE, PMA and CTD/eCTD submissions.
Delivery of courses and workshops on nonclinical drug safety, impurities/leachables/extractables, and device safety topics through third-party course providers.
Application of QSAR and computational toxicology tools to predict toxicological endpoints, metabolism, and support impurity assessments.
Advisory services covering preclinical and early clinical safety assessment, study strategy, and product safety evaluation for drugs, devices, and combination products.
Toxicological risk assessments including impurity qualification, leachables and extractables evaluation, and derivation of exposure-based limits.
Conduct of GLP analytical and preclinical audits, GMP manufacturing audits, and compliance assessments for domestic and international operations.
Preparation of regulatory documentation and support for interactions with regulatory authorities, including IND, NDA, ANDA, 510(k), IDE, PMA and CTD/eCTD submissions.
Delivery of courses and workshops on nonclinical drug safety, impurities/leachables/extractables, and device safety topics through third-party course providers.
Application of QSAR and computational toxicology tools to predict toxicological endpoints, metabolism, and support impurity assessments.
Expertise Areas
- Toxicology consulting
- Preclinical and early clinical safety evaluation
- Toxicological risk assessment (impurities, leachables, extractables)
- Regulatory submission preparation and interactions
Key Technologies
- Quantitative structure–activity relationship (QSAR)
- Toxicokinetic (TK) and pharmacokinetic (PK) analysis
- Leachables and extractables testing workflows
- Exposure-limit derivation (PDE/TI/TE/F-value calculations)