The Peach Pitch
Your Global partner for Contract Research Outsourcing
The Peach Pitch
Comprehensive Consulting Solutions for Pharmaceutical and Biotech Companies
The Peach Pitch is a contract research outsourcing management consultant that specializes in supporting pharmaceutical and biotech companies. We provide expert guidance and management services for regulatory affairs, laboratory testing, and project management for IND submissions to the USFDA. Our team of experienced professionals helps clients navigate the complex regulatory landscape and ensure successful IND filings.
Comprehensive Preclinical Services
Full IND Packages
Small and Large Molecules: Comprehensive investigational new drug (IND) packages tailored for both small and large molecules, including immune-oncolytics.
Exploratory Toxicology Studies
Small and Large Animal Imaging: Cutting-edge exploratory toxicology studies with advanced imaging techniques for small and large animal models.
Regulatory Toxicity Studies
Duration Ranges: Thorough regulatory toxicity studies spanning from short-term (2 weeks) to long-term (2 years) evaluations.
Genotoxicity Studies
Genotoxic Potential: Detailed genotoxicity studies to assess the genetic safety profile of compounds.
Reproductive Toxicity Studies
Reproductive Safety: In-depth reproductive toxicity studies to evaluate potential impacts on fertility and developmental processes.
Carcinogenicity Studies
Cancer Risk Assessment: Comprehensive carcinogenicity studies to determine the long-term cancer risk associated with drug candidates.
Safety Pharmacology Studies
Safety Profile: Rigorous safety pharmacology studies to assess the safety and pharmacological effects of new drugs.
Toxicokinetic Studies
Toxicokinetic Analysis: Detailed toxicokinetic studies to understand the absorption, distribution, metabolism, and excretion of toxic substances.
Drug-Metabolite Studies
Metabolite Profiling: In-depth studies on drug metabolites to assess their safety and efficacy.
Drug-Impurity Studies
Impurity Analysis: Comprehensive studies on drug impurities to ensure purity and safety.
Inhalation Toxicity Studies
Respiratory Safety: Specialized inhalation toxicity studies to evaluate the impact of compounds on respiratory health.
Comprehensive Clinical Services
Clinical Trial Phases
Phase I-IV Trials: Expert management and execution of clinical trials across all phases, from early-stage Phase I trials to post-marketing Phase IV studies. Each phase is meticulously designed to assess the safety, efficacy, and overall benefit-risk profile of new therapeutic interventions.
Regulatory Monitoring
Compliance and Oversight: Rigorous regulatory monitoring to ensure compliance with global regulatory standards and guidelines. Our team provides continuous oversight to navigate the complex regulatory landscape, ensuring smooth and timely progression of clinical trials.
Medical Writing
Scientific Documentation: High-quality medical writing services encompassing the preparation of clinical study reports, regulatory submission documents, manuscripts for publication, and other scientific communications. Our experienced medical writers ensure clarity, accuracy, and adherence to regulatory requirements.
Quality Assurance
Standards and Practices: Robust quality assurance processes to maintain the highest standards of clinical trial conduct. This includes regular audits, monitoring visits, and adherence to Good Clinical Practice (GCP) guidelines to ensure data integrity and patient safety.
Data Management
Data Integrity and Analysis: Comprehensive data management services to handle the entire data lifecycle, from collection and entry to validation and analysis. Our advanced data management systems ensure accuracy, security, and accessibility of clinical trial data, facilitating efficient and effective decision-making.
Our Regulatory Experience
Contact Us
Email us today to discuss your Regulatory planning!
The Peach Pitch
Hours
Open today | 09:00 a.m. – 05:00 p.m. |
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