Regulatory Services > A to Z of Regulatory Services
A to Z of Regulatory 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
ACBS applications
Accelerated Assessment preparation
Advertising and promotional materials review
Advisory meeting preparation
Annual Safety Report writing
Appeals
Audit preparation – all types
B
Bibliographic Application
Biologic
Biosimilar Application
Biotechnology Advice, Application, Expert report writing
Borderline Products
Braille
Branding
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 application
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 Publishing
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
In-house Medics
In/Out Licensing
Innovator applications
Interim Management
Investigational New Drug preparation (IND)
Investigator Brochure (IB) reviewing, updating
L
Leaflets and Labelling - review, translation and Readability Testing
Liaison with Competent Authorities
Licensing In/Out - Due diligence
Line Extension applications
Literature searches/review
Local Safety Officer
M
Manufacturer’s Licence
Market Analysis
Marketing Authorisation Application (MAA)
Marketing Authorisation maintenance
Medical device, drug-device combination products application
Medical Information Service
Medical Writing
Mock-inspections (GMP, GLP & GCP)
Module 1, 2, 3, 4 and 5 of CTD
Mutual Recognition Procedure (MRP)
N
Named Patient Supply
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
Own Label Supply
P
Packaging requirements
Paediatric Investigation 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 Service
Plant Master File (PMF) preparation
Price and Reimbursement
Product Development
Product sale/acquisition - due diligence
Project Management
Q
Qualified Person for GMP
Qualified Person for Pharmacovigilance
Quality overall summary (QOS)
R
Renewals
Regulatory maintenance
Regulatory Strategy
Responsible Person
Risk Management Plan (RMP) preparation
Registered Technical Documents (RTD) - In-house template
S
Scientific Advice Procedures/Meetings
Strategic Advice
SME Application
Submission preparation
Summary of Product Characteristics (SPC) writing and amending
Sun Set Clause waivers
T
Technology Transfer
Toxicology Expert (ex MHRA)
Traditional Herbal Registration (THR)
Transmissible Spongiform Encephalopathies (TSE) certification
Type I and II variations
Translations
U
Unlicensed medicines - supply
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