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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