Comprehensive Nonclinical Consulting Services

ENQUIRIES:

Phone:

(01) 1 949 293 1692

Email: rlphelps@usa.net

Company Profile

PharmAdvance Consulting, Inc. is a professional nonclinical consulting company focused on the safety assessment of drug candidates.  We offer high-quality, timely and confidential guidance to assist clients in the scientific and strategic execution of pharmaceutical  development programs. 

We offer nonclinical scientific direction, program management, and study placement and monitoring services in support of investigational and new drug applications. Our consultants work independently or as team members to provide specific expertise in various nonclinical disciplines.  We also provide nonclinical document preparation for regulatory applications.  We have specialized experience in the safety assessment of small molecules and botanically derived drug substances administered by systemic, parenteral, dermal and inhalation routes. 

Our clients encompass the domestic and international pharmaceutical industries.

Areas of Expertise

•  Safety Evaluation/Risk Assessment

•  Acute/Subchronic/Chronic Toxicology

•  Dermal Toxicology

•  Inhalation Toxicology

•  Carcinogenic Evaluation

•  Reproductive Toxicology and Teratology

•  Pharmacodynamics/Pharmacokinetics

•  Pathology

•  Safety Pharmacology (Cardiovascular, Respiratory, CNS)

•  Lab Animal Medicine (Clinical & Regulatory)

•  Nonclinical Model Development

•  Unique administration routes (surgical, ophthalmologic)

•  Technical Compliance

Services

•  Program management/logistics oversight

•  Study design and management

•  Study protocol preparation

•  Study report review, data interpretation

•  CRO liaison: External assessments, contracts, QA/QC

•  Preparation of nonclinical regulatory documentation

•  FDA/Regulatory authority interaction

•  In-license drug candidate assessment/due diligence

•  Safety Pharmacology techniques, training, laboratory setup

•  Veterinary Specialty Services

•  Pathology Specialty Services

•  Inhalation Technology/Biomedical Engineering

•  Computer software validation

•  Literature search/review

•  Technical Writing: position, scientific assessment

•  Service referrals

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Contact Information

Phone: (01)  1-949-293-1692

FAX:    (01)  1-949-362-8902

GGeneral Information/Inquiries:     rlphelps@usa.net

Postal address:

PharmAdvance Consulting, Inc

Robyn L Phelps, PhD

97 Cottage Lane

Aliso Viejo, CA  92656    USA

*  Member Roundtable of Toxicology Consultants