Generic Industry Services

Genericlicensing is able to arrange certain industry services via its approved partners to help ensure your company and products meet the industry requirements for licensing and manufacturing. Achieving the highest standards in all of these areas will significantly increase the probability of gaining clients.

The following services are offered:

Product development selection

Based on your business needs and capabilities and in combination with commercial, legal and market intelligence; Genericlicensing will help you determine which products you should develop or license.

This is a most critical part of any business success in generics and access to the services of Genericlicensing could be the key.

Manufacturing cGMP compliance and audits (API and Finished Dose)

One of the most challenging elements to supplying product to highly regulated pharmaceutical markets is the quality compliance of manufacturing facilities. Such work requires a great deal of planning, training and commitment; especially if a first approval. Genericlicensing is able to provide a full package to help guide your team through the complex project planning through to arranging the relevant inspections from recognized auditors, inspectors and health authorities.

Dossier compilation assistance

In order to comply with the latest formatting guidelines for dossier submission and to ensure minimal issues during the approval process, it is highly recommended that development and documentation systems are design to build-in compliance. Genericlicensing is able to offer both training programs to help you set up the required procedures or hands-on assistance during each project.

Dossier NTA to CTD formatting

If you have older dossiers that need updating to comply with the latest formatting standards; Genericlicensing is pleased to offer this as part of the complete package of services.

Dossier evaluation and upgrading

In order to increase the possibility of securing clients and reduce potential deficiencies during the approval process, Genericlicensing recommends an independent audit of a dossier. Should the evaluation highlight the need for improvements before submission; the relevant work can be undertaken or an upgrade plan suggested and monitored until satisfactory completion.

Regulatory procedure planning and management (National, MRP and DCP)

A considerable amount of planning is needed to execute a successful program of getting marketing authorisations in the shortest time. A carefully created strategy is needed to obtain marketing approvals in a way which will satisfy the authorities' requirements for all relevant data regarding the safety, efficacy and quality of your product.

Genericlicensing offers a service that includes the preparation of regulatory submissions via national, Mutual Recognition or Decentralised Procedures.

In addition, the compilation of clinical and non-clinical overviews, Summary of Product Characteristics and Patient Information Leaflets and labels (in all EU languages), and answering to authority response letters can also be managed on your behalf.

Post approval support

Once a product has been approved, Genericlicensing can offer a service that prepares documentation for renewals, variations, or legal status switches in all European countries, as well as support for any post-submission regulatory issues that might arise.

Service fees are based on client requirements; please request a consultation for us to discuss your specific needs.

Consultation

Service fees

Service fees are based on client requirements; please request a consultation for us to discuss your specific needs