A to Z List of Services

Please refer to our sister company’s website (www.realregulatory.com) for additional services.

A

Abridged application
Active Substance Master File (ASMF)
Advertising and marketing materials review
Advice on EU Medicines Legislation
Agency meeting
Analytical development – regulatory advice
Annual Product Review (APR)
Annual reporting for type IA variation
Appeals and hearings
Arbitration
Article 10(1) essentially similar or generic application
Article 10(3) hybrid application
Article 10(a) bibliographic application
Article 10(b) application for new fixed combination
Article 10(c) informed consent application
Assessment of scientific data

B

Background research
Batch Specific Request/Variation
Bespoke training
Bibliographic and on-line research
Bibliographic application
Bioavailability – comparative
Bioequivalence
Biosimilar products
Bolar provision
Bridging studies and reports
BROMI application (UK)

C

Centralised Procedure (CP)
Certificate of Free Sale or Certificate of Pharmaceutical Product request
Certificate of Suitability (CoS or CEP)
Change control – advice on the regulatory impact of complex changes
Change of Ownership submission
Clinical development strategy
Clinical expert report
Clinical overview
Clinical – strategic advice
Clinical summaries
CMC – chemistry, manufacturing and controls
Clock stop minimisation strategy
Coaching
Common Technical Document (CTD) format
Community list entry – review and interpretation
Community monograph – review and interpretation
Company-specific training
Competent /Regulatory Authority – liaison with
Compilation of key regulatory documentation
Complaint handling
Compliance program development
Contract manufacturer search
Controlled drug application
Consultancy
Country-specific advice

D

Data exclusivity
Decentralised Procedure (DCP)
Deficiency letter, response to
Directive review and interpretation
Dissolution testing strategy and evaluation
Dossier preparation and review
Drug development advice
Drug Master File (DMF)
Due diligence

E

Electronic Common Technical Document (eCTD)
Essential similarity to an EU reference product
European Drug Master File (EDMF)
European guideline and legislation interpretation
European procedure
European Reference Product (ERP)
European regulatory affairs
Existing drug substance
Expert advice
Expert statement, overview and summaries – pharmaceutical, non-clinical and clinical

F

Filing strategy
First to market
Fixed combination products
FOI: Freedom of information request
Formulation development – regulatory advice

G

Gap analysis
Generic product
Generic pharmaceutical industry
Generic Marketing Authorisation Application
Generic substitution listing
Grouped variations
Guidance review and interpretation

H

Herbal medicine
Herbal product
Homeopathic product
Human medicinal product
Hybrid application

I

Information on regulatory requirements
Informed consent application
In-country consultants
In-house placement
Intellectual property
Interim management
International regulatory requirements
Interpretation of guidance documents and legislation

K

Known drug substance

L

Labelling compliance review
Labelling requirements
Large molecules
Legal status and reclassification application
Liaison with EU Competent Authorities
Licence application
Licence transfer application
Lifecycle management
Line extension
Literature reference search and sourcing
Literature review


M

Maintenance application – renewals and variations
Manufacturing rationalisation (site transfers)
Mapping of regulatory activities
Marketing Authorisation Application (MAA)
Marketing Authorisation maintenance
Market exclusivity
Medical writing
Mentoring
Mutual Recognition Procedure (MRP)

N

National application
Network of experts
New Marketing Authorisation Application (MAA)
New product licence application
Niche products
Non-Clinical Overview
Non-Clinical Summaries
Notification (type IA/IA(IN))

O

On-site placement and interim management
Outsourcing – regulatory
Over-The-Counter product (OTC)
Own-Brand Labelling (OBL)

P

Parallel import licence application
Patent expiry
Patent protection
Patient Information Leaflet (PIL) – user testing and bridging report
Periodic Safety Update Report (PSUR)
Pharmaceutical development and licensing strategy
Pharmacology – advice and report writing
Pharmacovigilance
Position paper review and interpretation
Post-marketing requirements
Preparation and submission of EU regulatory documentation
Pricing and reimbursement applications
Procedure – writing/review/update
Process mapping of regulatory activities
Product labelling
Product recall assistance
Project management
Promotional materials – Preparation, review and compliance

Q

Qualified expert
Qualified Person
Quality Assurance
Quality Overall Summary

R

Readability testing
Recall/advisory notice
Reclassification (POM – P/OTC)
Reference product, choice of
Regulation review and interpretation
Regulatory Affairs Department – external
Regulatory Affairs Department – virtual
Regulatory and technical review and consulting
Regulatory Authorities – liaison with
Regulatory Compliance due diligence and review
Regulatory Compliance Support
Regulatory gap analysis
Regulatory intelligence
Regulatory strategy/advice/guidance
Regulatory submission process mapping
Regulatory submission tracking
Renewal of licence
Request for Information (RFI), response to
Response to Agency Questions
Review of documentation (due diligence)
Roche-Bolar provision

S

Small molecules
Speed to market
Stability studies – bulk
Stability studies – ICH
Stability studies – in-use
Stability studies – photostability
Stability studies – protocol design
Stability reports
Strategic and regulatory planning
Submission of application
Submission tracking
Summary of Product Characteristics (SmPC)
Supply status reclassification

T

Tailored training course
Technical agreement
Technical transfer
Technical writing
Therapeutic equivalence
Toxicology – advice and report writing
Tracking of regulatory submissions
Traditional herbal medicines registration
Training
Transfer of marketing authorisation holder
Type 1A/IA(IN) notification
Type 1B variation
Type II variation

U

Urgent safety restriction
User testing of Patient Information Leaflet (PIL)

V

Variation to product licence
Veterinary medicinal product

W

Workshop style training