A-Z of Services

A-Z of Services

Abridged applications
Active Pharmaceutical Ingredients (Active Substance Master Files and Certificates of Suitability)
Advertising and promotion - regulatory implications of
Agency meetings and preparation
ARMs - Applications to reclassify medicines
Audit preparation

Bibliographic applications - Article 10a of Directive 2001/83/EC
Borderline products

CE marking
Centralised Procedures
Change of ownership applications
Claims support
Clinical Trial Applications
Clinical Overview - writing and reviewing
CTD Common Technical Document - formatting and conversion
CTD preparation - Modules 1-5

Decentralised Procedure (DCP)
Device regulatory consultancy
Dossier preparation and review
Drug - device combinations
eCTD Electronic Common Technical Document
EU regulatory requirements

Gap Analysis
Generic products - Article 10(1) of Directive 2001/83/EC

Herbal medicines

Information searches and reports

Legal status (legal category) changes (POM to P; P to GSL switches)
Literature searches and reviews
Line extensions

National applications
NeES (Non eCTD Electronic Submissions)

Marketing Authorisation Applications (MAA)
Medical Devices
Mutual Recognition Procedure (MRP)

Overviews

Pharmaceutical regulatory consultancy
Piggy-back applications
PSURs - Periodic Safety Update Reports - Literature searching

Quality Systems: ISO13485; GLP and GMP; microbiological controls
Quality Overall Summary (QOS)

Reclassifications (legal category change)
Regulatory strategy
Renewals
Responses to Questions (Requests for Information - RFIs)

Safety variations
Scientific advice
Sterile Products: advice about sterilisation methods and interpretation of standards
Strategic advice
Summary of Product Characteristics (SmPC) - writing and amendments
Switch applications (legal category change)

Traditional Herbal Products Registration Scheme (THRs)

Variations to Marketing Authorisation Applications

Well-established use applications - Article 10a of Directive 2001/83/EC

About Empatec

We are an experienced team of consultants with a track record of delivering results.

Read more

Our Services

We provide advice to companies developing, manufacturing, marketing or licensing products.

Read more

Sectors

Empatec works across all key pharmaceutical and healthcare sectors.

Read more

Contact Us

Contact us today to discuss your current regulatory issues or to plan future requirements.

Contact Us