+44 (0) 1582439705
info@a-cs.co.uk

A-Z-Services

Our full A to Z list of services is as follows:
 

A

  • Advice on EU Medicines Legislation
  • Abridged Applications
  • Adaptive Licensing Pathways
  • Agency Meetings
  • API Sourcing
  • Artwork for Labels and Leaflets
  • Assessment of Scientific Data
  • Audits for GMP/GLP/GCP/GVP

B

  • Batch Release

C

  • Centralised Submissions
  • Change of Ownership Applications
  • Change of Legal Status
  • Clinical Overview
  • Clinical Study Reports
  • Clinical Summaries
  • CMDh Referrals
  • Contract Manufacturing Coordination
  • CTD Conversion
  • Conformity Assessment
  • Contract Manufacturers Searches

D

  • Decentralised Submissions
  • Distribution advice
  • Dossier Preparation and Review
  • Drug Master Files
  • Due Diligence

E

  • eCTD Publishing and Submissions
  • Electronic Submissions
  • Emerging Markets
  • Essential Requirements Checklists
  • Eudravigilance
  • EV WEB
  • Expedited Safety Reporting
  • Expert Witness

G

  • Gap Analysis
  • Generics Applications
  • Generics Licensing Opportunities
  • Global Regulatory Intelligence
  • GCP Consulting and Audits
  • GLP Consulting and Audits
  • GMP Consulting and Audits
  • GVP Consulting and Audits

H

  • Hybrid Applications

I

  • In-house Regulatory Support
  • In-house User Testing
  • ISO 13485 Consulting and Audits
  • ISO 9001 Consulting and Audits

L

  • Labels, Leaflets and Summary of Product Characteristics
  • Liaison with Regulatory Authorities
  • Licence Maintenance
  • Licensing Negotiations
  • Linguistic Review
  • Literature Searches                

 

 

 

M

  • Management Advice on Regulatory Operations
  • Manufacturing and Wholesale Distribution Authorisations
  • Marketing Authorisation Applications
  • Medical Information
  • Medical Writing
  • Mutual Recognition Submissions

N

  • National Marketing Authorisation Submissions
  • NeeS Submissions
  • Non-Clinical Overview
  • Non-Clinical Summaries

P

  • Package Leaflet
  • Periodic Safety Update Reports (PSURs)
  • Pharmacovigilance
  • Pharmacovigilance System Master File
  • Pharmacovigilance Training
  • Product Development Planning

Q

  • QPGMP/QC Release
  • QPPV
  • Quality Overall Summary (QOS)
  • Quality Systems

R

  • Readability
  • Recommendation of Best Route to Market
  • Regulatory Authority Inspections
  • Regulatory Compliance
  • Regulatory Intelligence
  • Regulatory Strategy
  • Renewals
  • Risk Management Plans

S

  • Safety Reporting
  • Scientific Advice
  • Searches for New Products or Licensing Partners
  • Signal Detection
  • Small & Medium Enterprise (SME) Applications
  • Summary of Product Characteristics (SmPC)

T

  • Technical Files
  • Technology Transfer
  • Training and Seminars
  • Translations

U

  • User Testing/Consultation

V

  • Variations
  • Vigilance Services

W

  • Wholesale Dealers Authorisation

Get in Touch