A to Z Services

A
Abridged Applications
Accelerated Assessment preparation
Active implantable medical devices
Active substance master files
Advanced Therapy Medicinals Products (ATMPS)
Adverse event reporting
Advertising and marketing materials review
Advice on drug supply chain rationalisation
Advice on EU Medicines Legislation
Advisory meeting preparation
Agency Meetings
Annual Product Review (APR)
Annual reporting for type IA variations
Appeals & hearings
Applicant and sponsor enterprise services for EU
Arbitration
Assessment of scientific data
Audits of quality & regulatory systems (pre-inspection, supplier, internal)
Assessment of regulatory implications of development plans

B
Brexit implications and strategy
Batch Specific Request/Variation
Bespoke Training
Bibliographic and on-line research
Bibliographic applications
Biological, biotechnology and mainstream pharmaceuticals
Borderline product applications
Bridging Studies and Reports
BROMI applications (UK)

C
CE Marking – documentation, strategies and Notified Body or Competent Authority interaction
Centralised Procedure (CP)
Certificate of Pharmaceutical Product application (CPP)
CESP Submissions
Change of Ownership Submissions
Classification (determination)
Classification of medical devices
Clinical Advice
Clinical evaluation report (CER)
Clinical expert reports
Clinical overviews
Clinical summaries
Clinical Trial Applications (CTAs)
Clinical Trial/Investigation Application
Clinical Trial/Investigation plan/protocol
Clinical Trial management
Clinical Trial Publishing
CMC – chemistry, manufacturing and controls
Combination products (device/medicine, medicine/device, medicine/medicine, medicine/delivery modification system)
Common Technical Document (CTD) format
Common Technical Specifications (IVD high risk products)
Company-specific training
Competent /Regulatory Authorities – liaison with
Compilation of key regulatory documentation
Complaint handling
Compliance program development
Compliance of quality systems
Contract manufacturers searches
Controlled drug applications
Consultancy
Conversion of regulatory documents to EU format
Coronary stents
CTD dossier publishing for submission
Custom made devices

D
Decentralised Procedure (DCP)
Declaration of Conformity (Medical Devices)
Design dossiers
Design verification/validation
Determine conformity assessment route (Medical Devices)
Determine product classification
Development Safety Update Reports
Development strategy
Device directives requirements
Device/drug combinations
Diagnostics
Directives review and interpretation
Distribution advice
Dossier Preparation and review
Dossier due diligence for suitability for submission in EU
Drug Development Advice
Drug/device combinations
Drug Master Files (DMFs)
Drug product development strategy
Due diligence

E
EAMS Process
Electronic Common Technical Document (eCTD)
Essential requirements checklist (medical devices)
Established product trouble shooting and development strategy
Ethics committee submissions
Ethical pharmaceuticals
European Drug Master Files (EDMFs)
European guidance & legislation interpretation
European procedures, US procedures and other international market procedures
Expert statements, overviews and summaries – pharmaceutical, non-clinical and clinical

F
Filing strategy
Flexible regulatory solutions
FOI: Freedom of information requests

G
Gap Analysis
Generic pharmaceuticals
Generics Application
GMP quality system expertise
Grouped variations
Guidance review and interpretation

H
Hands-on regulatory support
Herbal Medicines
Herbal products
Homeopathic products
Human medicinal products
Hybrid Applications

I
Incident reports
IND to EU IMPD Conversion
Information on regulatory requirements
In-house placement
Interim Management
Internal Audits
International regulatory requirements
Interpretation of guidance documents and legislation
Instructions for Use (IFU) and compliance with regulations
Investigational Medicinal Product Dossiers (IMPDs)
Investigator brochure review
In-Vitro Diagnostics
ISO 9001
ISO 13485
ISO 14971

J
Joint Scientific Advice and Health Technology Assessment

L
Labelling compliance review
Labelling requirements
Legal status and reclassification applications
Liaisons with EU Competent Authorities and Notified Bodies
License applications
License transfer applications
Line extensions
Literature reference searches and sourcing
Literature review

M
Maintenance Applications – Renewals & Variations
Manufacturing Rationalisation (Site Transfers)
Mapping of regulatory activities
Marketing Authorisation Applications (MAA)
Marketing Authorisation Compliance Audit
Marketing Authorisation Holder (MAH) in EU
Marketing Authorisation Maintenance
Medical device directive
Medical device vigilance and reporting systems
Medical Information
Medical writing
Modified Known Components
Monthly/quarterly medical device reporting
Mutual Recognition Procedure (MRP)

N
National Applications
NDA to EU MAA Conversions
New Chemical Entities (NCE)
New Marketing Authorisation Applications (MAAs)
New product licence applications
Non-Clinical Overview
Non-Clinical Summaries
Notification (type IA/IA(IN), IB, II)
Notified Body – liaison with

O
On-site Placement & Interim Management
Operational support for regulatory activities
Orphan Drug Applications
Orphan Drug Designation Applications
Oversight of EU Regulatory activities
Over-The-Counter products (OTC)
OTC Switch Application
Own-Brand Labelling (OBL)

P
Paediatric Investigation Plans (PIPs)
Paediatric study submissions (Article 45 and 46)
Patient Information Leaflet (PIL) – user testing and bridging reports
Perform regulatory gap analysis
Periodic Safety Update Reports (PSURs)
Pharmaceutical development & licensing strategy
Pharmacovigilance
PIP Deferrals
PIP Waivers
Position Paper
Post-marketing requirements
Pre-inspection & Post-inspection Auditing (ISO 9001/ISO 13485)
Pre-submission meetings
Preparation and submission of EU regulatory documentation
Preparation of agency response documents
PRIME
Procedures – writing/review/update
Process mapping of regulatory activities
Product labelling for marketed & investigational medicinal products
Product recall assistance
Project management
Promising Innovative Medicines Designation (PIM)
Promotional materials – Preparation, review and compliance
Protocol Advice process (Scientific Advice for Orphan medicinal product)
Protocol compilation and review
Provision of medical device classification and pre-market strategy

Q
QPPV
Qualified Experts
Quality Assurance
Quality management systems – ISO 9001/ 13485
Quality manual – writing/review/update
Quality Overall Summary
Quality systems set up, management and auditing

R
Readability testing
Recalls/advisory notices
Reclassification (POM – P)
Regulatory and technical review and consulting
Regulatory Authorities – liaison with
Regulatory Compliance Auditing, Management and Support
Regulatory intelligence
Regulatory strategy/advice/guidance
Regulatory submission process mapping
Regulatory submission tracking
Renewal of license
Reporting of adverse events
Requests for scientific advice
Response to Agency Questions
Review of documentation (due diligence)
Risk analysis/assessment
Risk management file
Risk management process
Risk management training
Risk Management Plans

S
Safety reporting
Safety variations
Scientific advice briefing documents
Scientific advice support and planning
Serious Adverse Event (SAE) Processing
Serious adverse event reporting
Single use devices
Small & Medium Enterprise (SME) Applications and support
Sponsor of EU Orphan Designation
Standards updates (international/national)
Strategic and regulatory planning
Submission of applications
Submission tracking
Substantial Amendments to Clinical Trial Applications
Summary of Product Characteristics (SmPC)
Summary Technical Information (STED)
Supplier Audits
Supply chain rationalisation advice

T
Tailored Training courses
Technical Agreement review
Technical Files
Tracking of regulatory submissions
Traditional herbal medicines registration
Transfer of marketing authorisation holder
Type 1A/IA(IN) notifications
Type 1B notifications
Type II variations

U
User testing of Patient Information Leaflets (PILs)

V
Variations to product licenses
Veterinary medicinal products
Vigilance
Virtual EU regulatory department set up and management

Real-Regulatory-call-to-action-0102-1600x160