Guiding your product from concept to launch
Services
The following is a list of services that we provide and areas of expertise:

A
Abbreviated new drug applications (ANDAs)
Abridged applications
Active implantable medical devices
Amendments (CTAs, INDs etc.)
Annual safety reports (ASRs)
Anti-infective products
Appeals (medical devices)

B
Biological and biotechnology products
Biosimilars
Blood products
Borderline products

C
CE marking
Centralised procedures
Change of ownership applications
Changes to medicinal product names
Clinical hold negotiations (FDA)
Clinical trial authorisation (CTA) applications
Combination products
Common technical document (CTD)
Consultancy
Controlled substances

D
Decentralised procedure
Declaration of conformity (medical devices)
Design dossiers
Device/drug combination products
Devices
Due diligence

E
Electronic Common Technical Document (eCTD)
EMEA submissions/liaising
Emergency investigational drug products
Ethics committee applications
EU pharmaceutical legislation
EudraCT applications
Exemptions (from licensing)

F
Fast tracking (of license applications)
FDA submissions/liaising
510(k) (premarket notifications)
Food supplements

G
Gap analysis
Gene therapy products
Generic products
Guidance review and interpretation
Guideline advice

H
Herbal and homoeopathic products

I
Immunologicals
In vitro diagnostics
In-licensing/out-licensing
Investigational medicinal product dossiers (IMPDs)
Investigator’s brochures (IBs)

L
Labels, patient information leaflets and packaging
Legal representation (in the EU)
Legal status and reclassification applications (Rx-OTC, POM-P, P-GSL switches)
Liaising with regulatory authorities
Licence applications
Licence transfer applications
Life cycle management
Line extensions

M
Marketing authorisation applications (MAAs)
Medical devices
Medical device reimbursement
Monoclonal antibodies (MAbs)
Mutual recognition procedures

N
Naming of medicines
Narcotics
National applications
Negotiations with regulatory agencies
Nutraceuticals
New chemical entities (NCEs)
New product development (NPD)
Non-eCTD electronic submissions (NeeS)
Notified body submissions/liaising
NPD idea generation
NPD in-licensing/out-licensing opportunities and collaboration
NPD marketing positioning and strategy
NPD portfolio/project management
NPD project management

O
Oncology products
Ophthalmic products
Orphan medicinal product designation applications
Over-the-counter products (OTCs)

P
Paediatric investigational plans (PIPs)
Patient information leaflets (PILs)
Periodic safety update reports (PSURs)
Post-marketing activities
Preclinical consultations
Premarket notifications (510(k)s)
Prior approval supplements (NDAs, ANDAs)
Project management
Promotional materials
Protocol assistance requests
Protocol development/review

Q
Quality (module 3) – writing/review/update
Quality overall summaries – writing/review/update

R
Radiopharmaceuticals
Reclassification applications (Rx-OTC, POM-P, P-GSL switches)
Reference member state (RMS) requests
Regenerative medicinal products
Regulatory affairs training
Regulatory consulting
Regulatory intelligence
Regulatory strategy/advice/guidance
Reimbursements (medical devices)
Renewal of licences
Requests for protocol assistance
Requests for scientific advice
Respiratory and allergy medicinal products
Review of documentation
Risk analysis/assessment
Risk management files/process

S
Scientific advice requests
Single use devices
Small and medium-sized enterprise (SME) designation applications
Somatic cell therapy products
SPC (Ukraine) submissions/liaising
Standard operating procedures (SOPs) – writing/review/update
Steroid medicinal products
Strategic and regulatory planning
Submission of applications
Summary of product characteristics (SmPC) – writing/review/update
Sunset clauses
Supplements (NDAs, ANDAs)

T
Technical files
Traditional herbal medicines products
Training (module preparation and presentation)
Transfer of marketing authorisation holder
Type IA, IB, II variations
Type A, B, C meeting requests (FDA)

V
Vaccines
Variations – Type IA, IB, II

W
Withdrawals
Work instructions – writing/review/update

X
Xenogenic cell therapy products