Files

The SYNERLAB Group can help you to draft your files (licence agreements for pharmaceutical products and food supplements developed on its Spanish site and new product development).

DRAFTING OF FILES

THE REGULATORY AFFAIRS TEAM ON OUR ALCALÁ FARMA SITE CAN PREPARE, STRUCTURE AND DRAFT YOUR FILES IN CTD AND ECDT FORMATS…

Preparation and structuring in CTD or eCTD formats:

The CTD format (or eCTD for the electronic format) is the international format for regulatory submission files and is intended to facilitate the evaluation and exchanging of information between the competent authorities. It defines the organisation of quality, safety and efficiency data and is structured in different modules according to the European pharmaceutical framework:

Module 1 – administrative information:
– Product information (SPC),
– Application form,
– Expert declaration and CV (description of qualifications, training, professional activity),
– API documentation (CEP, ASMF, etc.) & ALCALÁ FARMA (as a manufacturer of finished products).

Module 2 – Summary of non-clinical and clinical pharmaceutical data from modules 3, 4 and 5:
– Introduction,
– Overview of clinical & non-clinical quality data

Module 3 – Quality

Modules 4 & 5 – Non-clinical & clinical information.

 

… AND SIMPLIFY YOUR REGISTRATION PROCEDURES

ALCALÁ FARMA serves as a local contact for officers from the Spanish Health Authorities in monitoring registration procedures from the submission procedure until the granting of a marketing authorisation (MAH). ALCALÁ FARMA also maintains local contacts with the health authorities for scientific evaluations of the introduction of new products in GMP facilities (e.g. food supplements and medical devices).

 

OUR ASSETS

As a result, we are able to provide:
– Responses to all validation questions (quality, safety, efficacy) during the drug registration period;
– Statutory information underpinning API documentation and ALCALÁ FARMA product excipients;
– Further information concerning new quality variations;
– Regulatory evaluations for new projects;
– Further information concerning the improvement of drugs manufactured by ALCALÁ FARMA (e.g. for the manufacturing or improvement processes for analytical methods);
– Information relating to the adaptation of former files to current scientific regulations and new guidelines relating to quality;
– Further information relating to internal teams (manufacturing, quality assurance, quality control, development area, marketing teams, etc.).

 

To consult our list of pharmaceutical and food supplement files Click here