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CLINICAL RESEARCHERS

T&C Compounding has the resources you need to conduct the most advanced research & development or clinical trials

Premium Laboratories for Clinical Trials

Town & Country Compounding is a 503A ACHC accredited sterile and non-sterile compounding pharmacy lab. We are accredited in USP 795 and 797 compounding as well as USP 800 for both USP 795/797. Our new state of the art pharmacy compounding laboratory was designed to enhance our capabilities working in clinical studies.

Why Town & Country for your Clinical Research?

 Town & Country utilizes only:

  • State-of-the-art equipment
  • Highest quality ingredients
  • Innovative closing devices
  • Expert & highly trained sterile and non-sterile compounders

 Town & Country is committed to quality and patient safety

T&C is one of only 2% of compounding pharmacies nationwide who have achieved PCAB accreditation

  • PCAB accreditation is only achieved by pharmacies committed to compliance and continuous quality improvement
Town & Country can provide the necessary flexibility, variation, and customization by providing:
  • A range of medication strengths
  • Various dosage forms
  • Various routes of administration
  • Various excipients
  • Blinded or unblinded product
  • Smaller batch sizes

 JOHN HERR, RPh, T&C Owner

With over 25 years of compounding experience, John Herr is considered to be one of the experts in the compounding industry.

  • Past President International Academy of Compounding Pharmacists (IACP)
  • PCCA Compounding Pharmacist of the Year, 2007
  • NJ Hospice Pharmacist of the year
  • Served on the following boards:
    • IACP, Board Member
    • CSPN, Board Member
    • MHA, Specialty Pharmacy Advisory Board
Compounding pharmacies are uniquely positioned to assist researchers by:
  • Reducing costs
  • Improving efficiency
  • Increasing Flexibility
  • Reducing production
tcc-logo-white
ACHC/PCAB Accredited Pharmacy.
New Jersey & NYC’s Expert Compounding Pharmacy.
FDA Inspected

Clinical Research Phase Studies

Town & Country Compounding Pharmacy is often asked to participate in the  various phases of drug research and development.  This may include developing new drugs or using new combinations or doses of existing drugs.

Clinical Research Phase studies involve

  • Discovery and Development

  • Preclinical Research

  • Clinical Research

Source: FDA

We work with the pharmaceutical company, university and others in this initial research phase to ensure the stability, delivery method, concentration, dosage, pH, packaging, labeling, quality and accuracy of the drug being studied prior to proceeding to the different phases of the clinical trial.

For example, in the research phase a compounding pharmacy is needed to determine things such as:

  • Formulation development
    • Preclinical development of various bases and delivery systems prior to initiation of Clinical Trials
    • Concentrations of active ingredients in formulation
    • For analytical testing
    • For animal testing
  • Stability studies for potency, sterility, endotoxin, pH, container closure systems and forced degradation stability studies
  • Stability of the active drug with the other multiple excipients in the formulation
  • Stability and compatibility of multiple active ingredient combinations
  • The pharmaceutical delivery method  (dosage form) necessary to administer the drug to the patient
  • Optimal pH for drug stabilization and/or patient comfort and tolerance
  • Potential degradation issues of the active drug in different delivery vehicles 
  • Container closure systems necessary to increase drug stability and maintenance of sterility (if it is a sterile product)
  • Secondary packaging for the container closure system to further enhance stability of the drug during shipping and storage.

Research & Development 

Town & Country Compounding has years of experience with clinical trials. We have helped with the development of  IND, NDA and ANDA drugs. Our team often assists the researcher or manufacturer with suggestions to the development of the study plan and/or research protocol before the clinical trial begins.

Clinical Trials

  • Phase 0
  • Phase 1
  • Phase 2

Source: FDA

Types of FDA Applications

  • Investigational New Drug (IND)
  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)

Source: FDA

Our Track Record

Town & Country Compounding has participated in studies and clinical trials for many types of active ingredients, combination drugs, and various dosage forms including but not limited to:

  • Sterile drugs used in IV’s (parenteral medications)
    • Vials
    • IV bags
    • Prefilled syringes
  • Alternative bases for drugs to achieve better active drug delivery
  • Oral medications
    • Delayed release capsules
    • Immediate release capsules
  • Sterile ophthalmic drugs
  • Sterile bladder irrigations
  • Nasal sprays and irrigations
  • Topical creams and gels

Randomization, Packaging, Labeling and Tracking for the Clinical Investigation Site

We work with the statistician and the statistician’s randomization code to ensure both the active pharmaceutical ingredient and the placebo are properly blinded to all clinical investigators. We also work with the client to develop the proper labeling for the study. As required by the FDA ,we enter all patients and or subject ID numbers into our pharmacy dispensing system as a unique group of subjects for the trial. This ensures if there is a need to perform a recall, we have traceability of what the subjects in the trial have received.

We always initiate a non-disclosure agreement (NDA) to keep the clients proprietary information confidential. 

Let’s Get Started

Whether you require ten doses or thousands of doses for your R&D or clinical trial phase, Town & Country Compounding can deliver!

We take pride in working with your team from initial development of the study or trial and through all aspects of the study or trial up until completion. 

Challenge: Phase I & II studies are often complex and expensive.

   Solution: Take advantage of T&C 503A Research Resources at a fraction of the cost of production compared to pharmaceutical manufacturers or 503B facilities.

Why use a 503A pharmacy?

Bring your product to market more quickly and less expensively.

  • Less testing required before product release which:
    • Reduces Laboratory testing cost
    • Reduces length of testing time
  • Allows the flexibility to prepare a number of different dosage, strengths, dosage forms, and routes of administration in response to emerging clinical data without multiplying the cost.
  • The amount of product prepared can be determined by the scope of the study.
503A vs. 503B Pharmacies

In the DOSA, the FDA distinguishes between 503A (compounding pharmacies) and 503B (pharmaceutical manufacturers) facilities.

Unlike 503B facilites,section 503A exempts compounding pharmacies from having to follow the FDA’s cGMP regulations as outlined in 21 CFR Part 211 and 21 CFR Part 210.

Instead, 503A pharmacies must follow the regulations set by the USP (United States Pharmacopeia ) Compounding Compendium and the NF (National Formulary)

ARE YOU INTERESTED IN CONDUCTING RESEARCH WITH T&C?