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Neopharm Labs Inc. - To continuously improve
performance and apply technologies to serve our
client partnership, while investing in competent
personnel and talent, and creating a culture of pride in
our work.
2
3
 1990 – Neopharm begins operations in Blainville
 1996 – Acquired by MDS Pharma Services
 2006 – Warnex Acquires Neopharm from MDS
◦ Company operates 2 sites (Laval, Blainville)
 2011 – Restructuring of both labs into Blainville
 April 2012 – Warnex Analytical Services division sold to private
investors.
◦ New name: Neopharm Labs Inc.
3
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 IT (DAS, infrastructure, hardware, LIMS) : $950 K
 Instrument Upgrade: GC, HPLC, UPLC, Dissolution,
Light Scattering : $875 K
 New Service : ICP-MS : $225 K
 Stability Chambers – Expansion : $250 K
 Microbiology – Biolog & Others : $50 K
 Total investment: $2.35 M
7
 Inspected by the US Food and Drug Administration
May 2012
 Certified by Health Canada’s Health Products and Food Branch
Inspectorate (HPFBI)
May 2011
 Controlled Drugs and substances License
April 2012
 Audited and qualified by many global pharmaceutical
organizations
88
 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 135
Square Footage:
•Blainville
•Laval
44 000
11 000 (ex Warnex)
Certificates of
Analysis
1000-1500/mth
HPLC’s
UPLC’s
30
4
GC’s 8
AAS 2
ICP-MS 1
Dissolution
Apparatus
10
9
 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
16
 We analyze many types of samples including but not limited
to:
◦ Pharmaceutical, veterinary, cosmetics
◦ 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
23
 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
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 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:
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 Team led by Malika Madi – 25 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 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
29
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 Scientific Solutions
◦ OOS Resolution
◦ Available Team for Communication
 Validation
 Stability Programs
 Narcotic Vaults
 Full Service Analytical Lab
31
 Business Development – Eric Ittah
◦ Ext.: 364 eittah@neopharm.ca
 Business Development – Marie-Josée Lachapelle
◦ Ext.: 330 mjlachapelle@neopharm.ca
 Customer Service
◦ Ext.: 326, 368 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
31
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Neopharm Labs Inc.
865 Michele-Bohec
Blainville (Quebec)
J7C 5J6
www.neopharm.ca
Tel: (450) 435-8864
Fax: (450) 435-7595
32

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Eric Ittah - Consultant Neopharm Labs | Eric Ittah

  • 1.
  • 2. 2 Neopharm Labs Inc. - To continuously improve performance and apply technologies to serve our client partnership, while investing in competent personnel and talent, and creating a culture of pride in our work. 2
  • 3. 3  1990 – Neopharm begins operations in Blainville  1996 – Acquired by MDS Pharma Services  2006 – Warnex Acquires Neopharm from MDS ◦ Company operates 2 sites (Laval, Blainville)  2011 – Restructuring of both labs into Blainville  April 2012 – Warnex Analytical Services division sold to private investors. ◦ New name: Neopharm Labs Inc. 3
  • 4. 4  IT (DAS, infrastructure, hardware, LIMS) : $950 K  Instrument Upgrade: GC, HPLC, UPLC, Dissolution, Light Scattering : $875 K  New Service : ICP-MS : $225 K  Stability Chambers – Expansion : $250 K  Microbiology – Biolog & Others : $50 K  Total investment: $2.35 M
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  • 7. 7  Inspected by the US Food and Drug Administration May 2012  Certified by Health Canada’s Health Products and Food Branch Inspectorate (HPFBI) May 2011  Controlled Drugs and substances License April 2012  Audited and qualified by many global pharmaceutical organizations
  • 8. 88  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 135 Square Footage: •Blainville •Laval 44 000 11 000 (ex Warnex) Certificates of Analysis 1000-1500/mth HPLC’s UPLC’s 30 4 GC’s 8 AAS 2 ICP-MS 1 Dissolution Apparatus 10
  • 9. 9  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
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  • 16. 16  We analyze many types of samples including but not limited to: ◦ Pharmaceutical, veterinary, cosmetics ◦ 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
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  • 23. 23  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
  • 24. 24  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:
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  • 29. 29  Team led by Malika Madi – 25 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 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 29
  • 30. 30  Scientific Solutions ◦ OOS Resolution ◦ Available Team for Communication  Validation  Stability Programs  Narcotic Vaults  Full Service Analytical Lab
  • 31. 31  Business Development – Eric Ittah ◦ Ext.: 364 eittah@neopharm.ca  Business Development – Marie-Josée Lachapelle ◦ Ext.: 330 mjlachapelle@neopharm.ca  Customer Service ◦ Ext.: 326, 368 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 31
  • 32. 32 Neopharm Labs Inc. 865 Michele-Bohec Blainville (Quebec) J7C 5J6 www.neopharm.ca Tel: (450) 435-8864 Fax: (450) 435-7595 32