Products & Services

eCTD Implementation and Outsourcing:

Implementation, validation and training for ISI's Regulatory Solutions Suite of software incorporating eCTDXPress, ISIToolBox, ISIWriter and ISIPublisher
Software-as-a-Service (SaaS)
eCTD Submissions outsourcing including scanning, OCR, Document eQC, electronic and paper publishing

Regulatory Affairs Consulting:

Pharma To Market offers a comprehensive range of consulting services and can assist you with:

Project management
Identification of data requirements for key markets
Preparation of entire pre-approval and post approval submissions
Application review for acceptability of filing (including DMFs)
Technical advice, preparation of technical documents and scientific justifications (process and validation reports, pharmaceutical development reports, stability monitoring/trending etc)
Training

Pharma To Market offers the following technical and regulatory services to the pharmaceutical industry featuring in each of the following regions.

USA

Preparation and submission of Abbreviated and New Drug Applications (ANDAs and NDAs) (including conversion of 'old' style 22 Part ANDAs to (e)CTD format)
Amendments
Supplements (CBE-30, CBE-0, Labelling Supplements)
Annual Reports

Canada

Preparation and submission of Abbreviated and New Drug Submissions (ANDSs and NDSs)
Responses to Clarifaxes
Notices of Non-Compliance
Level 1, 2 and 3 Variations
Annual Reports

Europe

Preparation and submission of Marketing Authorisation Applications (MAAs) (via centralised, decentralised or national procedures)
Responses to Questions
Type 1A, 1B and II variation applications
Renewals

Australia

New Zealand

South East Asia (including ASEAN)

Analytical and Compliance Services:

Pharma To Market also offer Analytical and Compliance Services to industry including:

services