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Analytical Services
Services
 Chemistry/Chromatography
 Microbiology
 Sterility Testing
 Method Development &
Validati...
Certifications
 Inspected by the US Food and Drug Administration
May 2012
 Certified by Health Canada’s Health Products ...
Analytical highlights
 Well-established businesses
since 1990
 Dominant market position
in Quebec
 Modern facilities
 ...
Chemistry and
Chromatography
 Our skilled and competent Chemistry group uses a wide range of
methods to test both raw mat...
Samples Analyzed
 We analyze many types of samples including but not limited
to:
 Pharmaceutical, veterinary, cosmetics,...
Analytical Services
Provide
 Dissolution studies
 Spectroscopy UV-VIS, IR
 Physical and wet chemical analysis
 Residua...
 UPLC
 HPLC – UV/visible, diode-array, fluorometric, electrochemical,
conductivity, refractive index
 GC – Flame ioniza...
Microbiology & Sterility
Testing
 Neopharm Labs offers microbiology and sterility testing to help ensure
the safety of va...
Microbiology - Analytical
iServices Provided
 Antibiotic-microbial assays
 Antimicrobial effectiveness
testing (AET)
 M...
 Team led by Renaldo Lucherini 23 years experience in
pharmaceutical and bioanalytical method development and
validation....
 Method dev., Method transfer, Method validation,
Cleaning validation, USP verification, Forced
degradation studies, Assa...
Neopharm partnership
and tradition
 The quality and integrity of the work is what has
always distinguished Neopharm from ...
Contact Us
Neopharm Labs Inc.
865 Michele-Bohec
Blainville (Quebec)
J7C 5J6
www.neopharm.ca
Tel: (450) 435-8864
Fax: (450)...
Key contacts
 Business Development – Eric Ittah
 Ext.: 364 eittah@neopharm.ca
 Business Development – Marie-Josee Lacha...
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Analytical Services

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Eric Ittah is a successful Biopharmaceutical consultant from Canada.

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Transcript of "Analytical Services"

  1. 1. Analytical Services Services  Chemistry/Chromatography  Microbiology  Sterility Testing  Method Development & Validation  Stability Studies Market  Pharmaceutical  Biotech  Cosmetic  Veterinary
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
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