A-Z of Services

A

• Abbreviated New Drug
• Application (ANDA) Abridged Application Accelerated
• Assessment preparation
• Advertising and promotional materials review
• Advisory meeting preparation
• Annual Safety Report writing
• Appeals
• Audit preparation
  

B

• Bibliographic Application
• Biologic
• Biosimilar Application
• Biotechnology Advice, Application, Expert report writing
• Borderline Products
• Braille
  

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 submission
• 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 Management
• 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
• Interim Managment
• Investigational New Drug preparation (IND)
• Investigator Brochure (IB) reviewing, updating

L

• Languages - Native European Speakers
• Leaflets and Labelling - review, translation
• Liaison with Competent Authorities
• Licensing In/Out - Due diligence
• Line Extension
• Literature searches/review

M

• Manufacturer’s Licence
• Marketing Authorisation Application (MAA)
• Marketing Authorisation Maintenance
• Medical device, drug-device combination products application
• Medical Writing
• Mock-inspections (GMP, GLP & GCP)
• Module 1, 2, 3, 4 and 5 of CTD
• Mutual Recognition Procedure (MRP)

N

• 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

P

• Packaging requirements
• Paediatric Investgation 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
• Plant Master File (PMF) preparation
• Price and Reimbursement
• Product sale acquisition - due diligence
• Project Management

Q

• Qualified Person
• Quality overall summary (QOS)

R

• Renewals
• Regulatory maintenance
• Regulatory Strategy
• Risk Management Plan (RMP) preparation

S

• Scientific Advice Procedures
• Strategic Advice
• Submission preparation
• Summary of Product Characteristics (SPC) writing and amending

T

• Traditional Herbal Registration (THR)
• Transmissible Spongiform Encephalopathies (TSE) certification
  Type I and II variations

U

• 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

Regulatory Services

Reach the Pharma Market faster....
Cambridge Regulatory Services can help you can reach your regulatory goals faster either by guiding you through the complexities of the regulatory world or providing hands on support for any regulatory project.
It may be a cliché but no project is too small, we are happy to provide regulatory advice for as little time as half an hour. We are equally comfortable managing a 27 EU member state DCP, or acting as your regulatory department.

CambReg covers the complete range of Regulatory Services:

1. Regulatory Consultancy

2. Dossier Preparation for:

Clinical Trial Applications
Marketing Authorisation Applications
Variations
Renewals
Legal Status change
PSUR's

3. EU Procedure Management

National Applications
Mutual Recognition Procedure (MRP)
Decentralised Procedure (DCP) and DCP slot booking
Centralised Applications
Appeals

4. Setting up a company in EU

5. Specialist Services

User testing
eCTD in-house publishing on Lorenz Software
Paediatrics

6. Specialist areas

Orphan Drugs
Biotechnology
Herbals