Services

Pharmaceutical Product Development

Pharma-Data s.a. deals with the whole process of a new product development from the API (Active Pharmaceutical ingredient) until the CTD dossier preparation and final registration as well as the post-approval needs.
Our goal is the provision of high quality standards in every stage of the product development and/or life-cycle management either individually (taking over specific tasks as categorised below) or as a whole.

APIs (Active Pharmaceutical Ingredients)

APIs (Active Pharmaceutical Ingredients)
Sourcing and Evaluation of APIs
Patent research,
Evaluation of documentation or preparation of documentation,
Coordination of GMP auditing and approval of the API manufacturer.

Galenical Development

Preparation of lab scale batches
Product patent evaluation
Compatibility and pre-stability studies
Essential similarity
Container compatibility study (ICP/MS, GC/MS etc)

Manufacturing process

Sourcing of the appropriate Drug Product Manufacturer (CMO)
Manufacturing process development and validation
Coordination of GMP auditing and approval by EU and FDA

Stability testing

According to ICH guidelines covering Zone III
and IV Photo stability

Analytical Development and validation

Justification of specifications
Drug product release testing
Method transfer
Validation of microbiological methods (sterility, BET etc)
Filter Validation (for sterile products – leachables, extractables, challenge tests)

Dossier Writing

eCTD dossier preparation
DCP/MRP submission and follow up
Life Cycle Dossier Management

Regulatory Affairs & General Services

Regulatory Strategy Advice

Dossier Update:

Transformation of existing old file into the latest CTD format

Method and Tech Transfer

Transfer of the production between different manufacturing sites

Cost improvement, quality aspects etc

Contact with authorities

Batch Analysis (products imported outside EU) (in collaboration with UoA)

Other regulatory affairs services

Food Supplements, Neutraceuticals

Cosmetics, Dermocosmetics

Variations

Renewals