Pharmaceutical Regulatory Affairs – Are your mature products in regulatory compliance?

Regulatory Affairs is a complex area within development and maintenance of pharmaceutical products. It demands considerable resources and expert knowledge of the regulatory procedures and national competent authorities.

A-consult provides high-quality regulatory assistance to companies both pre- and post-marketing. Our Regulatory Affairs Department consists of expert consultants, who work closely with European authorities and we are continuously keeping up to date with current developments within the field of regulatory affairs.

One of the many challenges within regulatory affairs is to keep mature products in regulatory compliance. Are all of your mature products in regulatory compliance? Why not let A-consult give your products a compliance review?

We have reviewed many mature products for regulatory compliance and we can deliver a full report of the review including a list of classified variations, which need to be submitted before the product is in regulatory compliance. We can also manage the preparation, submission and handling of the identified variation package.

Inspirational list of other services we provide:

• Strategic advice on the regulatory and administrative procedures of the Nordic countries
• Preparation, submission and management of MAA, renewal and variation applications
• Translation of product information
• Conversion of dossiers to CTD format
• Preparation of NeeS and eCTD dossiers
• Compilation, review and update of drug master files (DMF)
• General advice on regulatory requirements in the Nordic countries

The above list is by no means exhaustive. A-consult offers different concepts of outsourcing in order to fulfil your requirements:

Special Tasks Concept:
The special tasks concept concerns well-defined tasks, i.e. preparation of an e-CTD; strategy advice or review of marketing materials.

Optimise Capacity Concept:
To optimise your capacity we can offer continuous support to take off the top of work pressure in your company. It could be a support defined as a certain amount of hours a month.

Total Outsourcing Concept:
We can function as your regional or national regulatory department.

For more information or to discuss pharmaceutical regulatory affairs please contact us directly.