SERVICES

 
 

INDUSTRIES WE SERVE...
  Pharmaceuticals
  Biopharmaceuticals / Biologics / Immunologics / Diagnostics
  Active Pharmaceutical Ingredients (APIs) / Bulk Drugs
  Pharmaceutical Excipients / Additives / Adjuncts
  Medical Devices / Disposables

A COMPREHENSIVE MENU OF SERVICES... (Click here)


SERVICES FOR WORLDWIDE MARKETS… (Click here)


A wealth of expertise is available to you from PharmAlliance in India and our associates in Europe, USA, Canada and other countries...

We customize extremely cost-effective service packages to meet your exact needs. We can shorten your time to market… and keep you up to speed.
 
 

 FACILITY DESIGN AND DEVELOPMENT / PROJECT SERVICES (Click here)
  PharmAlliance specializes in conceptualizing and designing of state-of-the-art manufacturing,
    testing, and  R&D facilities conforming to the most rigid international cGMP/GLP/GCP (cGXP) norms.
  PharmAlliance specializes in modernization of existing facilities to achieve full cGXP compliance.
  PharmAlliance develops quality systems (Manufacturing / Control Documentation and SOPs) to
    achieve full cGXP compliance.
  PharmAlliance integrates first-hand knowledge of worldwide regulations and highly specialized
    project engineering and project management skills to offer the most complete package of project
    consulting services.
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 REGULATORY AFFAIRS (Click here)
  PharmAlliance has first-hand knowledge of worldwide pharmaceutical regulations.
  PharmAlliance provides insight into how the regulatory agencies think and what data they will need
    to approve specific products.
  PharmAlliance clarifies regulatory issues, anticipates potential problems, and gets products to
    approval through the fastest and most direct route possible
  PharmAlliance has extensive experience in interacting with FDA (USA),  TPD (Canada), EMEA, EDQM
    and EU National Authorities, including MHRA (UK), MCC (South Africa), TGA (Australia), and other
    regulatory agencies worldwide.
  PharmAlliance specializes in preparing and handling regulatory submissions for all major world
    markets. (Click here for details for DMF / EDMF / CEP / COS / ANDA / ANDS / Abridged MAA)
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 SUPPORT SERVICES FOR PRE-CLINICAL, CLINICAL AND BIOEQUIVALENCE STUDIES
  PharmAlliance provides support services for studies across the entire pre-clinical and clinical
    research spectrum ….  Phase I, II, and III trials as well as bioequivalence studies for European and
    North American markets
  PharmAlliance has links with reputed CROs in USA, Canada, Europe (including Eastern Europe),
    and India.
  PharmAlliance facilitates access to the comprehensive resources, expertise, and experience of
    such reputed CROs.
  PharmAlliance evaluates CROs worldwide and provides expert guidance for selection of CROs
    and negotiations for outsourcing studies.
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 TRAINING AND EDUCATION (Click here)
  Regulations, Regulatory Procedures, Strategic planning for Regulatory Affairs :
    FDA (USA), TPD (Canada), European Union, TGA (Australia), MCC (South Africa), WHO
  Compliance Management for International Markets
  Quality Systems, Manufacturing and Control Operations
  Validation
  Bioequivalence Studies for Regulatory Submissions
  Clinical Pharmacokinetics and Protocol Design for Regulatory Submissions
  Pre-Clinical and Clinical Research and Clinical Trials Management
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 BUSINESS DEVELOPMENT  (Click here)
  PharmAlliance has an extensive information base, and worldwide contacts.
  PharmAlliance provides insight into worldwide market opportunities for your organization.
  PharmAlliance assists with Patent Screening, Product/Market Selection, Strategy Development,
    Strategic Planning for International Market Development.
  PharmAlliance can help you gain entry into the profitable, multi-billion dollar North American and
    European markets and the rapidly growing markets of Asia and Latin America.
  PharmAlliance can help you in setting up of contract manufacturing and product licensing
    arrangements.
Full Service…Interactive Process… Successful Projects
 
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