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cGMP/GLP/R&D

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Registrations & Licenses

Chemic Document Control

Document Development

Import/Export Services

Consulting Services

 

 

 

 

Registrations and Licenses

•  Commonwealth of Massachusetts

   Controlled Substances Registration #'s  
   (Analytical Laboratory Schedules 1-6)             MA0090236

   (Manufacturing Schedule 2)                            MA0083965

 

•  Commonwealth of Massachusetts

   Service Mark Registration  #                        55507

 

•  Commonwealth of Massachusetts

   Radiation Control Program
   (Radioactive Materials License)                       55-0305

 

•  US Department of Justice

   Drug Enforcement Administration Controlled Substances
   (Analytical Laboratory)                                   RC0233508

   (Exporter Schedule 2)                                     RC0262206
   (Manufacturing Schedule 2)                            RC0265606

 

•  US Food and Drug Administration

   Analytical Laboratory Registration #            1225771
   Labeler code:                                                  001500

 

•  US Food and Drug Administration

   Manufacturing Registration #                       1225771
   Labeler code:                                                  65507

Value Added Services

*Lauryl Lactate

QC Analytical Services

 

ICH Stability Programs

 

Extractables & Leachables Analysis

 

  Bioanalytical Sample Analysis Methods Dev., & Validation

 

    cGMP Organic Synthesis  

(kg scale) & Formulations

 

  CMC Analytical

Development & Validation

Regulatory  & QA Services