Neopharm Labs provides analytical testing services including chemistry, microbiology, sterility testing, and method development and validation to the pharmaceutical, biotech, cosmetic, and veterinary industries. It has over 110 employees and 32,000 square feet of facilities in Quebec, Canada. Neopharm is certified by the FDA and Health Canada and audited by global pharmaceutical companies. It has a wide range of instrumentation and offers services such as dissolution testing, stability studies, and microbiological assays.

1. Analytical Services
Services
 Chemistry/Chromatography
 Microbiology
 Sterility Testing
 Method Development &
Validation
 Stability Studies
Market
 Pharmaceutical
 Biotech
 Cosmetic
 Veterinary

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

11.  Method dev., Method transfer, Method validation,
Cleaning validation, USP verification, Forced
degradation studies, Assays, Impurities, Residual
solvents, Formulation stability, Reverse
engineering.
 Microbiology Validation Team led by Isabelle
Gladu

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