SciencePharma | Library - SciencePharma

Product Development
Development
Commercialization
- Support and brokerage in product portfolio optimization
Clinical Trials
Study set-up
- Paediatric Investigation Plan
Study conduct

CSR writing / preparation

Full service Clinical Research Organization

PhV in Clinical Trials
Quality
CMC development
- Nitrosamines
- Risk assessment and Control of Elemental Impurities
Technology and analytical methods
- Analytical Methods Transfer
GMP system
- GMP system implementation
GxP Audits
GMP
GCP
- GCP Audits (remote and on site)
PhV
- GVP Audits (remote and on site)
GLP
- GLP Audits (remote and on site)
Regulatory Affairs
Pre-authorisation
- Scientific Advice
- Product information
  
  Preparation of product information
  
  Package Leaflet readability test
  
  Bridging Report
  
  Translation of Patient Information
- Dossier preparation
  
  Medical writing - preparation of registration dossier
  
  CTD Module 3 - Quality
  
  Product information
  
  Enviromental Risk Assessment (ERA)
  
  Orphan Medicinal products
- Dossier Gap Analysis
MA Handling
- Handling of the registration process
- eCTD compilation
Post-authorisation
Regulatory outsourcing
- Regulatory consulting in the pharmaceutical industry
Pharmacovigilance
PhV system
- Pharmacovigilance system (PSMF)
- RMP Development and maintenance
PhV post-authorisation
Clinical trials

EU QPPV service
QP Service / Importer

QP Service

Import and supply chain management

MIA Certificate

GMP Certificate

RFI

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Logo Science Pharma

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Group 82

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