Interquim

Making People Better

Customer Support

Analytical Development

The purpose of the analytical development unit is to provide support for our R+D department's activities and to meet our client's analytical pharmaceutical development needs.

Our analytical development unit's main activity is developing and optimising analytical procedures for the complete characterisation and monitoring of the quality of our products and manufacturing processes. The analytical development laboratory defines the specifications of our active ingredients, to ensure correct certification of their quality, and validates optimised methods to ensure their effective implementation in quality control laboratories, following ICH guidelines and the principles of the reference pharmacopoeias (US, EP, JP).
Based on exhaustive complementary studies, such as impurity characterisation and qualification studies, real-time and accelerated stability studies, forced degradation studies, solubility studies, hygroscopicity studies and polymorphism studies, among others, we guarantee full knowledge of our products.

The analytical support service for clients is one of our quality goals. This service includes the transfer of our analytical methods to our clients' laboratories.

Customer Support

Regulatory Affairs

The purpose of our regulatory department is to work to ensure our active ingredients obtain and maintain approval for marketing from health authorities. Regulatory activity continues throughout the life cycle of our active ingredients.

Our regulatory affairs department has extensive experience in dossiers for marketing authorisation (DMF/CTD, CoS) in the main world pharmaceutical markets, including the USA, EU and Japan.

We have a panel of experts for each of our main markets (USA, EU and Japan) who ensure our documentation complies with regulations, thus guaranteeing the success of our clients' authorisation applications.

Our approach is to maintain close relations with our clients throughout the product's lifecycle, from the first stages of development to the authorisation and marketing of our active ingredients.

Our regulatory affairs department ensures that all Interquim's product-related activities are performed properly and consistently in order to ensure the quality of our dossiers.

Customer Support

Intellectual Property and Legal Support

We guarantee that our manufacturing processes do not infringe any third-party intellectual property rights.

Our intellectual property experts continually analyse the legal situation of our products and resolve any specific doubts our clients may have, while strictly observing confidentiality agreements.

Interquim, s.a. works with law firms and panels of intellectual property experts in the main pharmaceutical markets, thus strengthening our policy of observing applicable legal requirements.

Our intellectual property department is also responsible for writing up, presenting and maintaining all applications for patents covering technology developed in Interquim, s.a. and relating to our manufacturing processes for active ingredients.