Pakistan Drugs Testing and Research Center
  • Hotline services


    042-35297281-4

Services

A: Pharmaceutical Analysis/Testing
A strategic partnership with PDTRC will provide a comprehensive array of cGMP-compliant analytical services: 1. Analytical Method Development and Validation
2. Assays
3. Physical and Chemical Tests
4. In-Process materials Testing
5. Finished Products Testing
6. Impurity, Metabolite and Degradation Product Identification
7. Raw Material Testing (USP/NF, EP, BP, JP)
8. Quality control Release Testing
9. Dissolution Testing

B: Microbiological Testing
PDTRC offers wide range of Microbiological Testing services including:
1. Sterility Testing 2. General Microbiological Testing
3. Bacterial Endotoxin Testing
4. Microbiological Assay for Antibiotics and Vitamins

C: Stability Testing
Stability Testing demonstrates how packaged regulated products are affected by temperature, humidity and light conditions over time. This data is used to establish shelf life and required storage conditions. PDTRC’s dedicated stability team provides services for all stages of product development, from early research & development to In-process to post-approval studies.
1. Stability Protocol Design
2. Shelf life Stability
3. Accelerated and Intermediate Studies
4. Stability Testing for IND, NDA, ANDA
5. Formulation Evaluation Stability Testing
6. Forced Degradation Studies
7. Freeze & Thaw Study
8. Formulation Capability Study

D: Bioequivalence Center
PDTRC understands Bioavailability/Bioequivalence and has the type of expertise you need in a CRO partner to assure your study is done right. PDTRC has a strong SOP driven culture and ensures compliance with all statutory and mandatory requirements. We provide our clients a dedicated Project Management team to serve as a single, knowledgeable point of contact and a dedicated Business Development team that is involved and able to assist in all aspects of your bioequivalence studies. 1. Fasting Bioequivalence Studies
2. Food Effect Bioequivalence Studies
3. Multiple dose and Steady State Studies
4. Pharmacokinetics of single dose
5. Relative Bioavailability and Absolute Bioavailability