Analytical Testing Services
Integrity & Accuracy Without Compromise
Shields Pharma Inc. is a privately held science based pharmaceutical and contract testing organization located in Markham, Ontario, Canada. We are approved by Health Canada holding, GMP Drug Establishment License (DEL) (No.: 3-002816-A) and Controlled Substances Dealer’s Licence (No.: 6-1497).
We offer a comprehensive range of R&D and QC analytical testing services to institutions engaged in Pharmaceutical (including controlled substances) and Nutraceutical research, development, formulation, manufacturing and distribution.
Ensuring product safety and efficacy, data integrity and compliance with Health agencies regulatory and quality requirements are farthermost priority to us.
Our dedicated and highly qualified laboratory personnel have long-standing experiences in areas of their technical specialties. All our scientists have proven track records of accomplishments on full method development and validation studies including, method optimization, method transfer, stability testing, cleaning validation, QC release, investigation studies, etc.
Our newly built state-of-the-art laboratories are equipped with the latest in analytical equipment and instrumentation that are operated in accordance with US FDA CFR part 211, ALCOA+ and ICH requirements for all our analytical method development and validation activities.
Shields Pharma Inc. follows and adheres to Health Canada, FDA, MHRA, EMA, and TGA guidance and regulations. All our practices, processes and procedures are routinely reviewed and updated against governing current regulatory requirements.
We support our clients at various stages of their analytical development, validation, QC and investigation processes.
Complete Analytical Solutions
Accurate and Precise Data with Comprehensive Testing Capabilities
Shields Pharma Inc. offers a comprehensive range of analytical services from raw materials to finished products, to support the pharmaceutical, dietary supplement, OTC, nutraceutical and allied industries.
Shields Pharma recognizes the growing interest in certain controlled substances’ potential therapeutic properties, qualities and efficacies. We have developed techniques to facilitate the production and analysis of stable, standardized formulations of these psychedelic species.
Shields Pharma Inc. is licensed by the Health Canada Office of Controlled Substances (OCS) to conduct certain authorized activities (including laboratory analysis) on substances and products.
Our team of skilled scientists backed by years of experiences are dedicated to delivering the highest quality, accurate, precise, and reliable results in competitive turnaround times in compliance with the current health authorities’ regulatory guidelines and requirements (i.e. GMP and GXP).
Analytical Capabilities Include:
- Full range of raw material testing (API/Excipients) in accordance with USP, BP, EP, JP and to client methods and specifications
- Finished product/stability testing (chromatography, dissolution, spectroscopy, heavy metals, wet chemical analysis and physical testing)
- Impurities Risk Assessment
- Full range of Controlled raw materials (APIs) and finished products (FPs)
- Stability testing (chromatography, dissolution, spectroscopy, heavy metals, wet chemical analysis, physical testing, etc.)
- Qualification and subsequent routine monitoring of water systems
- Analytical method validation as per ICH guidelines
- Process and Cleaning Validation (CV) analysis,
- Investigation Studies,
- Supporting Clinical Studies
Analytical Techniques
- GC Chromatography – GC, GC/MS, GC-HS, and GC/MS-HS, GC (TCD, FID, and MS Detectors)
- HPLC Chromatography – LC, LC-MS (UV, PDA, FLD and MS detectors)
- Chromatography – TLC and CombiFlash Rf+ Flash Chromatography
- Dissolution – USP 1 & 2, Profile, and Disintegration
- Elemental Analysis – ICP- MS, Wet Chemistry, Microwave Digestion
- Spectroscopy – UV-Vis, FT-IR
- Moisture determination – KF, Moisture analyzer, Drying
- Auto Titration
- Muffle furnace
- Hardness
- Friability
- Etc. …
Your business success is important to us. Shield Pharma Inc. with its highly experienced scientists and analysts offers precise, accurate and reliable QC service in a fast turnaround manner. Our laboratory is well-equipped with the latest analytical equipment and instrumentation qualified to meet regulatory requirements.
Our analysis are conducted in accordance to cGXP, the current pharmacopoeias (i.e. USP, EP, BP and JP) analytical methods and/or client’s specified method and specifications.
Method development, Optimization, Validation, and QC Release by
UV, HPLC, LC-MS, or GC, GC-MS, ICP-MS Analysis
Method development, Optimization, Validation, and QC Release by
UV, HPLC, LC-MS, or GC, GC-MS, ICP-MS Analysis
We Perform
Analysis On:
- Raw materials and Active pharmaceuticals ingredients (APIs)
- Excipients
- Finished products
- Natural Health Products
- Cannabis (cannabinoids)
- Psychedelic APIs and FPs
Our Analytical Chemistry Services Include … But Are Not Limited To:
- Identification (UV, IR, TLC, HPLC, GC, etc.)
- Assay (HPLC, GC, UV, Titrimetric)
- Impurities (HPLC, GC, TLC, Flash Chromatography)
- Dissolution and Dissolution Profile (USP 1 and 2)
- Residual solvents/Organic Volatiles (OVIs)
- Elemental Impurities/Heavy Metals/Trace Elements (ICP-MS, digestion)
- Titration (auto-titration, manual)
- Water Content (Karl-Fisher, Moisture analyzer, LOD)
- Melting Point
- Hardness
- Friability
- Optical Rotation
- pH
- Conductivity
- Total organic carbon (TOC)
- & More …..