A

• Abridged Applications
• Administrative and legal representation of foreign companies operating in Italy
• Advertising and marketing materials review
• Advisory meeting preparation
• Audit (preclinical, clinical, quality, regulatory) 

B

• Bibliographic & on-line research
• Bibliographic applications
• Biopharmaceutics (support to the development of improved formulations)
• Briefing documents for agency meetings
• Business Development strategic support

C

• Centralised Procedure (CP)
• Clinical Advice
• Clinical overviews and summaries
• Compilation of key regulatory documentation
• CMC – chemistry, manufacturing and controls - documentation
• Clinical Trial Applications to local and national Regulatory Authorities
• Compliance check of labelling, congresses, promotional materials, websites
• Core Data Sheets (CDS) 
• Cosmetics (regulatory assistance)
• CTD Dossier Preparation (Modules 1 to 5)

D

• Decentralised Procedures (DCP)
• Document drafting
• Dossier review and update
• Drug Master Files (DMFs)
• Due diligence of regulatory dossiers within acquisition projects of companies and products

E

• E-Submissions (eCTD, NeeS)
• Eudravigilance
• European guidance & legislation interpretation
• European procedures (DCP, MRP, centralized)
• Expert statements, overviews and summaries- pharmaceutical, pre-clinical and clinical

F

• Food supplements (development and regulatory assistance)

G

• Gap analysis (quality, regulatory, preclinical, clinical)
• Generic applications
• Good Manufacturing Practice (GMP) quality system expertise

H

• Hearings with Health Authorities 
• Herbal medicines
• Homeopathic products

I

• Intelligence activities (regulatory intelligence to identify and advise on local regulations and provide national input into regulatory projects)
• Interim Management
• Interpretation of guidance documents and legislation
• Investigational Medicinal Product Dossiers (IMPDs)
• Investigator brochure review

J

• Justification documents (response to HAS queries etc..)

K

• Key Opinion Leaders advice 
• Kinetics protocols and advice

L

• Leaflets & Labelling drafting and review
• Liaison with Health Authorities
• Licence applications
• Life-cycle management
• Literature reference searches, analysis and sourcing

M

• Marketing Authorization Applications (Centralised procedures, DCP, MRP, national procedures; full, abridged, hybrid, …)
• Marketing Authorisation Maintenance
• Medical Foods
• Medical Devices (regulatory assistance)
• Medical Writing: clinical protocols, IMPDs, Non Clinical/Clinical Summaries and Overviews (Modules 2.4, 2.5, 2.6, 2.7), protocols, reports.
• Modelling (PK, PD, trial design, trial optimisation) 
• Mutual Recognition Proecedure (MRP)

N

• National Procedures 
• Networking with local advisors and key opinion leaders
• Nutraceuticals (development and regulatory assistance)
• New Chemical Entities (NCE)
• New indications (review of data, preparation of application)
• Nutritional products

O

• Orphan Drug Applications
• Over-The-Counter products (OTC)
• Outsourcing (full, partial)

P

• Parallel import licence applications
• Patient Information Leaflet (PIL) – user testing
• Pharmacovigilance: monitoring of the PhV network, Adverse Drug Reports, Periodic Safety Update Reports, PhV SOPs, QPPV services, Risk Management Plans, management of EUDRAVIGILANCE in accordance with requirements established by the EU commission
• Post-marketing requirements
• Pricing and Reimbursement activities (P&R dossier, pricing strategies, planning and coordination of pharmacoeconomic studies, assistance in negotiations)
• Product development planning
• Procedures – writing / review / update
• Project management
• Promotional material (preparation and review)
• Protocol compilation and review

Q

• QPPV
• Quality Assurance and services
• Qualification of pre-clinical and clinical experimental sites and CROS

R

• Regulatory Compliance (GLP, GMP, GCP)
• Regulatory strategy/advice/guidance
• Renewal of registrations
• Reverse planning (from desired indications to clinical plan)
• Review of scientific documents 
• Risk Management Plans

S

• Scientific advice for licence applications
• Scientific Advice for the formulation of research protocols
• Scientific Advice from Regulatory Authorities 
• Scientific Papers
• Site audits, evaluation of corrective actions, compliance reports
• Standard Operating Procedures
• Start-up assistance
• Strategic planning 
• Study design and protocol preparation
• Summary of Product Characteristics (SmPC) writing (drafting)
• Switch (RX/POM to OTC)

T

• Technical Writing (Module 3 and 2.3, Active Substance Master File (ASMF), Drug Master File (DMF) preparation
• Traditional herbal medicines registration
• Training (internal personal, sales force)
• Transfer of ownership
• Translations (scientific and technical)

U

• Updating of approved dossiers
• User testing of Patient Information Leaflets (PILs)

V

• Variations (Type I, Type II; quality, safety, PhV, SmPC – indications, …)
• Veterinary medicinal products

W

• Weekly literature control for pharmacovigilance
• Writing (medical, technical)