A Personal Service from Experienced Professionals

A-Z of Services

 

If you can't find what you are looking for on our website or for more information on any of our services listed below please give us a call on 01480 465 755

A

  • Abbreviated New Drug
  • Application (ANDA) Abridged Application Accelerated
  • Assessment preparation
  • Advertising and promotional materials review
  • Advisory meeting preparation
  • Annual Safety Report writing
  • Appeals
  • Audit preparation

 

B

  • Bibliographic Application
  • Biologic
  • Biosimilar Application
  • Biotechnology Advice, Application, Expert report writing
  • Borderline Products
  • Braille

 

C

  • Centralised Procedure (CP)
  • Certificate of suitability application (CEP)
  • Certificate of Pharmaceutical Product (CPP)
  • Change in Legal Status (Prescription, OTC, General Sale)
  • Change of Ownership submission
  • Clinical Advice/Experts
  • Clinical overview writing
  • Clinical summary writing
  • Clinical Trial Applications (CTA)
  • CMC review, writing
  • Common Technical Document (CTD)
  • CTD formatting, conversion

 

D

  • Decentralised Procedure (DCP)
  • Development strategy
  • Dossier Preparation and/or Reviewing
  • Drug-device combination products application
  • Drug Master File
  • Due Diligence

 

E

  • e-CTD Management
  • EDMF
  • EDQM notification, renewals
  • Environmental Risk Assessment
  • Exceptional circumstances application
  • Expert report writing - Pharmaceutical, Non-clinical and Clinical
  • Expert advice - Pharmaceutical, Non-clinical and Clinical
  • Export Certificate

 

F

  • Filing Strategy
  • Free Sales Certificate

 

G

  • Gap analysis
  • GCP, GLP and GMP inspection
  • Generics application

 

H

  • Health Economics
  • Herbal Medicines
  • Homeopathic
  • Human Medicines
  • Hybrid MAAs

 

I

  • Investigational Medicinal Product Dossier (IMPD) preparation, reviewing, updating
  • In-house Placement
  • Interim Managment
  • Investigational New Drug preparation (IND)
  • Investigator Brochure (IB) reviewing, updating

 

L

  • Languages - Native European Speakers
  • Leaflets and Labelling - review, translation
  • Liaison with Competent Authorities
  • Licensing In/Out - Due diligence
  • Line Extension
  • Literature searches/review

 

M

  • Manufacturer’s Licence
  • Marketing Authorisation Application (MAA)
  • Marketing Authorisation Maintenance
  • Medical device, drug-device combination products application
  • Medical Writing
  • Mock-inspections (GMP, GLP & GCP)
  • Module 1, 2, 3, 4 and 5 of CTD
  • Mutual Recognition Procedure (MRP)

 

N

  • New Active Substance (NAS)
  • New Chemical Entity (NCE) application
  • New Drug Application (NDA) preparation
  • Non-Clinical summary writing
  • Non-Clinical overview writing
  • Non-Clinical advice/expert

 

O

  • Orphan Drug Designation (ODD) application

 

P

  • Packaging requirements
  • Paediatric Investgation Plan (PIP)
  • Paediatric Use Marketing Authorisation (PUMA)
  • Parallel Import
  • Package Leaflet (PL) User Testing
  • Patient Information Leaflet (PIL) User Testing
  • Periodic Safety Update Report (PSUR)
  • Piggy-back applications
  • Pharmacovigilance
  • Plant Master File (PMF) preparation
  • Price and Reimbursement
  • Product sale acquisition - due diligence
  • Project Management

 

Q

  • Qualified Person
  • Quality overall summary (QOS)

 

R

  • Renewals
  • Regulatory maintenance
  • Regulatory Strategy
  • Risk Management Plan (RMP) preparation

S

    • Scientific Advice Procedures
    • Strategic Advice
    • Submission preparation
    • Summary of Product Characteristics (SPC) writing and amending

T

    • Traditional Herbal Registration (THR)
    • Transmissible Spongiform Encephalopathies (TSE) certification
      Type I and II variations

 

U

  • Urgent Safety Restriction
  • User Testing (UT) of Package Leaflet/Patient Information Leaflet

V

  • Vaccine Antigen Master File (VAMF) application
  • Variations to Marketing Authorisation

W

  • Well-established use application
  • Wholesale Dealer Licence (WDL) application