2. Certifications
Inspected by the US Food and Drug Administration
May 2012
Certified by Health Canada’s Health Products and Food Branch
Inspectorate (HPFBI)
May 2011
2011Controlled Drugs and substances License
April 2012
Audited and qualified by many global pharmaceutical
organizations
Every two weeks
3. Analytical highlights
Well-established businesses
since 1990
Dominant market position
in Quebec
Modern facilities
FDA and HPFBI compliant
Niche in sterility testing
Large narcotics vault
Walk-in Stability Rooms
Employees Over 110
Square Footage 32,000
Certificates of
Analysis
1000+/mth
HPLC’s
UPLC’s
many
many
GC’s many
AAS many
ICP-MS one
Dissolution
Apparatus
many
4. Chemistry and
Chromatography
Our skilled and competent Chemistry group uses a wide range of
methods to test both raw materials and finished products in
accordance with compendial procedures
including but not limited to:
USP/NF, BP, Ph.Eur, JP, FCC,
ACS, AOAC, AOCS, In-house
and client supplied methods.
5. Samples Analyzed
We analyze many types of samples including but not limited
to:
Pharmaceutical, veterinary, cosmetics, natural health products.
Finished products: tablets, capsules, liquids, parenterals, otic and
ophthalmic drops, semisolids, creams, gels, shampoos and
suppositories
Raw materials: actives, fillers, binders, lubricants, colours and
other excipients
Container/packaging components: plastics, glass, foils, bottles,
strip packs and cards
In-process products: bulk mixtures of solids or liquids prior to
filling into capsules, bottles, vials and syringes, or before
compressing into tablets
6. Analytical Services
Provide
Dissolution studies
Spectroscopy UV-VIS, IR
Physical and wet chemical analysis
Residual solvents
Stability storage and testing
Method development and validation
Total organic carbon (TOC)
Process and cleaning validations
Container/packaging testing
Vitamin assays
Antibiotic assays
Enzymatic testing
7. UPLC
HPLC – UV/visible, diode-array, fluorometric, electrochemical,
conductivity, refractive index
GC – Flame ionization, and thermal conductivity detection, capillary
and headspace techniques, mass spectrometry
Dissolution – USP methods I, II, III and V
Spectroscopy – InfraRed and UV-VIS
AAS – Atomic Absorption Spectrophotometer Flame and graphite
furnace
ICP-MS
Instrumentation
8. Microbiology & Sterility
Testing
Neopharm Labs offers microbiology and sterility testing to help ensure
the safety of various products and ingredients including
pharmaceuticals, cosmetics, personal care
products, vitamins, water, veterinary products, natural health
products, etc. All analysis are performed in compliance with cGMP
requirements using methods from relevant compendia and
pharmacopoeia.
Our experienced microbiology team has expertise in a variety of
compendial assays, including:
USP/NF
AAMI
BP/ Ph.Eur
JP
AOAC
AWWA
FDA
Client supplied methods.
9. Microbiology - Analytical
iServices Provided
Antibiotic-microbial assays
Antimicrobial effectiveness
testing (AET)
Microbial limits
Bioburden analysis
Desinfectant testing
Optical microscopy
Water testing
Vitamins
Bacterial endotoxin test
Methods development and
validation
Particle size analysis
Microbial identification
Crystallinity
Sterility testing
The following analyses are performed in compliance
with cGMP requirements:
10. Team led by Renaldo Lucherini 23 years experience in
pharmaceutical and bioanalytical method development and
validation.
Collective team experience – 60 years
HPLC – RP, NP, Ion exchange
Detection – UV, DAD, FLD, ELSD, RID, and Conductivity
GC – FID, TCD
Method Development and
Validation Services
12. Neopharm partnership
and tradition
The quality and integrity of the work is what has
always distinguished Neopharm from the
competition. This is why Neopharm retains many
major global clients who trust us for all these years.
13. Contact Us
Neopharm Labs Inc.
865 Michele-Bohec
Blainville (Quebec)
J7C 5J6
www.neopharm.ca
Tel: (450) 435-8864
Fax: (450) 435-7595
14. Key contacts
Business Development – Eric Ittah
Ext.: 364 eittah@neopharm.ca
Business Development – Marie-Josee Lachapelle
Ext.: 330 mjlachapelle@neopharm.ca
Customer Service
Ext.: 331 sc@neopharm.ca
Director, Laboratories– Lina Iacobaccio
Ext.: 363 liacobaccio@neopharm.ca
Director, Quality Assurance – Nancy Shore
Ext.: 332 nshore@neopharm.ca
President and CEO– Luc Mainville
Ext.: 307 lmainville@neopharm.ca