Contract Manufacturing Pharmaceuticals
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About Contract Manufacturing
  • Becoming a Contract Manufacturer and Combining Active
    Pharmaceutical Ingredient Manufacturing and Sterile Liquid Filling
  • Contract Manufacturing : Reliability, Quality & Value 
  • FAQ
  • Successful drug development program
  • Good Manufacturing Practice (GMP) for the manufacturing of active pharmaceutical  ingredients (API)
  • The European agency for Evaluation of Medicinal Products
  • Guidance for Industry Q7A Good Manufacturing
    Practice Guidance for Active Pharmaceutical Ingredients
  • Contract Research Organizations
  • Compliance Program Guidance for Pharmaceutical Manufacturers in USA - April 2003
  • Biomanufacturing Challenges
  • Clinical Trials Directives

India Scenario

  • The Pharmaceutical Industry in India
  • More about The Pharmaceutical Market in India
  • India recognized as global pharma outsourcing hub
  • India & China Compared
  • Madras Pharmaceuticals
  • Dishman India
  • Medopharm
  • Ranbaxy

 Company Profiles / Reports

  • CellGenix - offer
  • Laureate Pharma Launches New Contract Manufacturing Venture
  • Outsourcing
  • From Cell-line Optimization to Process Development
  • ChemSource Exhibition Organizers
  • ChemSpec Exhibition at hyderabad
  • Hovid, Malaysia
  • International Medication Systems, CA
  • UTI Corporation
  • Envoy
  • Quintiles
  • Hovione
  • Endura
  • Novozymes Biopharma
  • American Peptide Company
Important Links
  • Pharma Outsourcing
  • Web Guide to Pharma Outsourcing
  • Outsourcing Questions
  • Oligo Production
  • DowPharma Literature
  • More Resources
 

World of Regulatory Information & Articles of Interest

  • The Site Master File (SMF)
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • Clinical Investigation in the UK - Directives
  • Clinical Investigation Application* Form PCA 1
  • Clinical Investigation Application Form PCA 2
  • Information for Clinical Investigators
  • Pre-clinical Assessment: Guidance for Assessors
  • Guidance on Biocompatibility Assessment
  • Requirements for UK Notified Bodies
  • Guidance Notes for Manufacturers of Class 1 Medical Devices
  • Guidance Notes for the Registration of Persons Responsible for Placing Devices on the Market
  • Guidance Notes for Manufacturers of Custom-made Devices
  • Guidance Notes for Manufacturers of Dental Appliances (Custom Made Devices)
  • Guidance Notes for Manufacturers of Prosthetic and Orthotic Appliances
  • Guidance Notes for Manufacturers on Statistical Considerations for Clinical Investigations of Medical Devices
  • Guidance Notes for the Registration of Persons Responsible for Placing In-Vitro Diagnostic Medical Devices on the Market
  • Guidance Notes on In Vitro Diagnostic Medical Devices Directive 98/79/EC
  • The CE Marking
  • The Vigilance System
  • Conformity Assessment Procedures
    Updated: February 2004
  • The Classification Rules
  • Sale and Supply of In Vitro Diagnostic Medical Devices (IVDs)
  • Standards
  • Medical Devices and Medicinal Products
  • The Medical Devices Regulations: Implications on Healthcare and other Related Establishments
  • Own Brand Labelling and Rented Products
  • Conformity Assessment Procedures under the In Vitro Diagnostic Medical Devices Directive 98/79/EC
    Updated: February 2004
     

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