Quality is paramount in the pharmaceutical industry as people’s lives are directly dependent on the quality of medicines given to them for the treatment of diseases. This highlights how important it is to have a reliable partner for testing and certification of pharmaceutical products and their ingredients.
Arbro offers pharmaceutical testing and research services to support the development, approval, and manufacture of pharmaceutical raw materials and finished products. Since its establishment in 1990, Arbro has accomplished an excellent reputation for its pharmaceutical analysis service, as a trusted contract laboratory.
Pharmaceutical and the related industries require “Commitment to Quality” for GLP and cGMP compliance. Arbro has demonstrated this over the decades, and is listed on a number of leading pharmaceutical manufacturer’s licenses as the contract analytical testing site.
Our pharmaceutical laboratory regularly undertakes:
- Pharmacopoeial testing based on USP, BP, EP or JP
- Testing using clients’ own or in-house methods
- Documented in-house validated methods
In addition, the company can develop and validate methods for use on raw materials, API’s or finished products. The laboratory has also undertaken work in support of process validation, cleaning validation and stability studies.
Whether it is routine QC testing, non-routine analysis, R&D projects or advice and consultancy, clients can trust Arbro to provide the appropriate outsourcing solution.
All of our staff are committed to the aim of meeting the need for a responsive, accurate, and reliable analytical support service required by these industries.
Arbro routinely undertakes contract lab testing of –
Arbro has a state of the art laboratory with equipment and analytical methodologies like: Chromatography (TLC, GC, HPLC, HPTLC, GC/MS, LC/MS/MS, GPC, Headspace Analyzer); Spectroscopy (FTIR, UV/visible, Atomic Absorption) Spectrometry (ICP/MS); Titrimetry, including Karl Fischer reagent and Oven/ Disintegration/Dissolution (including extended release); Osmometry; Carbon analyzer (TOC); Stability Studies by ICH Guidelines; Rheometry/Viscosity; and, Viable microbial air sampler, Malvern Particle Size Analyzer.
How Arbro Supports the Drug Development Lifecycle?
Pharmaceutical products are a crucial and important cornerstone of the global healthcare sector. Working towards eradicating global health issues is a high priority area for international development, and Arbro has been making impressive advances in the sector by testing and certifying pharmaceutical products for clinical and consumer use.
Developing life-saving drugs is a time and finance intensive process. Moreover, the process might be further delayed as the products have to go through several pharmaceutical testing procedures to ensure its safety and efficacy before it is rolled out for public use. Even a small mistake along the drug lifecycle may have far-reaching effects.
Arbro, one of the finest pharma testing labs in Delhi, extends its full services to pharmaceutical companies to support their way through the entire drug development process while meeting regulatory standards and requirements as well. Arbro stays with you at every step and phase of the drug development lifecycle.
Discovery and Development: A lot of efforts and finance goes into the research and development of pharmaceutical drugs. During this process, the pharmaceutical industry has to carry out research on general health issues and determine how they can offer a solution.
Arbro’ s pharma testing services offer characterization, method development and qualification assistance, and more during the discovery phase.
Pre-Clinical Research: In this phase, the toxicity, efficacy and pharmacokinetic information about the drug is determined.
Clinical Development: Following the completion of the pre-clinical research, further clinical trials and volunteer studies are conducted on the drug in pharmaceutical laboratories to calibrate it for human use. The clinical development phase is considered to be the most important step in the development of a new drug.
Review and Approval: After the drug has been formulated, the reports from the clinical trials are forwarded to be approved by the regulatory body for pharmaceuticals and medical devices – FDA in the US and The Central Drugs Standard Control Organization (CDSCO) in India.
After the approval, further inspections are performed to check the drug advertisements, implementing appropriate warning and reviewing complaints.
Arbro’s pharmaceutical testing services and programs are designed to offer assistance right from the discovery of the drug to the approval and post-approval phase.
1. Is your lab NABL accredited for testing pharmaceuticals?
Yes, our pharmaceuticals testing labs are one of the largest NABL accredited labs in India. The team of auditors of the National Accreditation Board for Testing and Calibration Laboratories (NABL) carried out an assessment of our labs. The assessment report of our pharmaceutical testing labs was evaluated by NABL and they granted us accreditation for chemical and biological testing.
Our labs in Delhi and Baddi are NABL accredited and Baddi lab is the only NABL accredited lab in Himachal Pradesh.
2. Is your lab approved by state drug control and CDSCO?
Yes, our labs are approved by state drug control and CDSCO. We have state of the art pharmaceutical laboratories in Delhi, Baddi (Himachal Pradesh), and Bangalore. All of our laboratories are recognized by their respective State Drug Control Departments/Authorities under the Drugs and Cosmetics Act. Also, our labs are approved by Central Drugs Standard Control Organization which is the national regulatory body for Indian pharmaceuticals and medical devices.
3. Do you provide reports on form 39 as per the Drugs and Cosmetics Act?
Yes, we can provide reports on form 39 as per the requirements of the Drugs and Cosmetics Act. We are entitled to do so because all our pharmaceutical testing laboratories are approved by the State Food and Drug Administration and CDSCO.
4. What services do you offer under pharmaceutical testing?
We offer the following services under pharmaceutical testing:
- Raw material testing
- Finished products
- Method validation
- Stability testing
- Analytical method development
- X-ray diffraction
We also offer services to support the development, approval, and manufacture of pharmaceuticals’ raw materials and finished products.
5. Do you allow customer audits and audits by foreign regulatory bodies?
Yes, we allow both customer audits and audits by foreign regulatory bodies.