Phase 1 Clinical unit located in St. Louis, Missouri, USA with 120 clinical beds.
Full-service CRO from study design inception to clinical trial execution. Data reporting and tabulation to the final Clinical Study Report including CDISC compliant
5-year contract with US FDA’s OGD to conduct in-vivo studies for generic drug products
Key areas of focus include Phase I clinical studies, PK/PD, Human Abuse Potential and Abuse Deterrent Assessments, BE/BA for all dosage forms (including solid oral formulations, transdermal patches, inhalation products and depot injections), Controlled-substances, DDI, FIH, SAD/MAD, Special populations, Medical Cannabis, First-to-File ANDA submissions to the US FDA
All FDA audits without Form 483 issued
BIOREPOSITORY RESOURCES
Ideally located in New Providence, NJ only 18 miles from Newark, NJ EWR airport
Secure, economical alternative for short term / long-term biological and retained sample storage
Storage of Materials at Ambient, 2-8°C, -20°C and -80°C
Inventory Management and expedited Sample Retrieval
Facility fully supported with Backup Generator
State-of-the-art environmental monitoring system providing continuous automated monitoring of critical parameters such as temperature, humidity
BIOSTUDY SOLUTIONS, LLC
Biostudy Solutions, headed by Chuck Bon, is a pharmacokinetic and biostatistical consulting firm with decades of experience working with hundreds of companies, helping them advance their generic and new drug submissions to U.S. and foreign regulatory authorities.
PHARMACOKINETIC / BIOSTATISTICAL CONSULTING – Protocol development, sample size calculations, EMD & IVPT analyses, Population bioequivalence analyses for In-vitro trials, PK/Statistical analyses for BA/BE studies.
VCA STUDY SUPPORT – Design, dose response modeling and interpretation & BE evaluations
Catawba Research is a full-service CRO providing clinical management services to pharmaceutical, device, formulation development and biotechnology companies submitting NDAs, ANDAs and 505(b)(2)s.
Ideally situated close to NC’s Research Triangle Park.
We are specialists in Recruiting and Clinical conduct of dermatology, women’s health and ophthalmology and specialty Clinical populations.
Experts in generating clinical research protocols and clinical study designs for BE/BA, Ph1/2/3, clinical programs.
With 40 Clinical trials completed including over 25,000 patients and more than 900 U.S. and Indian sites with clinical research experience, we are easily able to Recruit for your needs.
GCP Research
A niche FDA approved Clinical unit specializing in Women’s health, Dermatology, General medicine, PK/PD, Renal & Hepatic, NDA/aNDA/505(b)2 and Pain models.
Protocol development, Clinical Feasibility, Site qualifications, Project Management
Women’s health: pre-menopausal and post-menopausal subjects with experience using every dosage delivery indication (intra-vaginal, creams, lotions, and capsules)
DEA: licensed for schedule II to V controlled substances
Affiliated with Latin & South American clinics & partners
PharmSci Partners
PharmSci Partners LLC is a CMC and bioanalytical focused company that provides needed bandwidth to virtual and established companies. This includes supporting discovery and development activities to advance both drug substance and drug product, for either a new chemical entity or generic.
Due Diligence/Audit Services
Company Collaboration: clarifying areas such as strategy including life cycle management, intellectual property fencing, etc.
Alliance/Vendor Management: for work conducted by CDMO, CRO, and alliance partners
Project Management: Scope, budget, timing, risk management, and strategy
QUARTESIAN
Quartesian is headquartered in Princeton, NJ
500 Employees worldwide with facilities in India, Ukraine and United States
“Best in Class” Services focused on Data Management, Programming/Statistical Analysis, Pharmacovigilance, and Medical Writing
Experience in 20 therapeutic areas
99% on time and on budget record
SANNOVA
Sannova is headquartered in Somerset, NJ with 15+ yrs of experience and extensively FDA audited/approved
State-of-the-art Bioanalytical and CMC facility encompassing 21,000 sq. ft
Small & Large molecule expertise with 310,000 samples analyzed annually
Additional Services include: Biomarkers, In-Vitro Release and Permeation testing
Sannova’s Z-factor achieves highly accurate and precise data, with single-digit variability across most sample analyses
Streamlined efficiencies allow quicker timelines and optimal pricing
DEA & CDS Licenses for Schedule 2, 3, 4, & 5 Drugs
Storage facilities including Refrigerators, -20C and -80C Freezers
XYZAGEN
Drug development consulting and discovery contract in vivo nonclinical pharmacokinetics.
Clinical Pharmacokinetics, Modeling & Simulation and Regulatory development experts.
In-house rodent vivarium and bioanalytical mass spectrometry lab for early discovery exposure assessment and First-Time-in-Rodent™ PK studies.
Real-Time Interim Clinical PK Analysis and rapid study start for nonclinical studies.
Xyzagen’s scientists have over 25 years of drug development expertise in the therapeutic areas of Anti-Infectives, Ophthalmology, Neurology and Pain, to name a few, and understand development pathways for small molecules and biologics.
