Regulatory Affairs

We provide a complete and comprehensive range of services from A to Z: from product idea, through development and research, certification, registration and product delivery to the customerWith us, you can easily launch a new medical pharmaceutical device on the market or adapt an existing one t...

Phillips-Medisize collaborated with Subcuject to bring a ground-breaking wearable bolus injector to the market. This device is designed to be a low-cost, patient-friendly, pre-filled wearable injector for single-use.

CARBOGEN AMCIS has a track record, extending over 25 years, helping our customers transition their molecules from process development through validation and ultimately into commercial status. A range of services backed up with fully integrated support functions has been developed to facilitate and smooth the ...

In order to carry out its activities of R&D, prototyping and pilot batches preparation, Enable Innovations avails itself of a brand new production unit equipped with fully automated filling and packaging lines and laboratories complying with the most restrictive applicable regulations for medical devices ...

Seratec specializes in fine organic chemistry and is dedicated to active pharmaceutical ingredient (API) development & production for the pharmaceutical industry.
Seratec operates in highly regulated markets and where high quality products are critical.
Seratec offers a complete range of custom ...

Our dedicated QP Services team are able to provide compliance support, audit services, regulatory consultancy and QP certification for imported medicinal products.

We provide full-scope Good Manufacturing and Distribution Practice Services to ensure your compliance with the relevant EU and CIS legislation. We provide consultancy on all aspects of GMP and additional QP-services.  * Services of Qualified Person* Third Party Service set up for batch release ...

The objective is to develop an ERA of the Active Substance (AS) in a given formulation(s), for one or more countries.

Socosur proposes a 2 phases procedure, according to the adopted guideline:

PHASE I:Phase I estimates the exposure of the environment to the AS on the basis of consumption...

Recipharm have more than 20 years experience supplying clinical trial material to our clients. Our development facilities cater for a range of clinical trials from preclincal to smaller Phase III trials. We also offer commercial manufacturing for very large clinical batches.

Midas Pharma offers wide range of pharmaceutical services which includes regulatory affairs services. It offers regulatory support for human medicinal products, veterinary medicinal products and herbal medicinal products in Europe. This includes: • drug substance services: development of ASMF/EDMF...

Pediatric formulation and product development

The development of acceptable, palatable pediatric formulations is a key feature within the industry today, driven by patient needs and regulatory requirements. Quotient Sciences has extensive knowledge and capabilities that enable us to provide you wi...

For pharmaceutical products, we offer support for regulatory services such as:
registration via national and European Union procedures;ANDA registration;
drafting of e-CTDs to create e-CTD sequences;
regulatory compliance;
minor and major variations (evaluation and/or management).For&...

For pharmaceutical products, we offer support for regulatory services such as:
registration via national and European Union procedures;ANDA registration;
drafting of e-CTDs to create e-CTD sequences;
regulatory compliance;
minor and major variations (evaluation and/or management).For med...

SUPPORT SERVICES FOR OUR CONTRACTED CUSTOMERS

• Analytical Development
• Validation Support
• Regulatory Support
• Clinical Supply Services

Bottle and blister lines fully serialized and aggregate.

Our experienced Regulatory Affairs Department’s goal is to give regulatory support to our clients, both during the pharmaceutical development as well as in the preparation of reports and specific requests:
Preparation of applications for orphan drugs designation (EMA and FDA).
Preparation of annual...

Our formulation, device and development services are supported by our medical, regulatory, device vigilance and pharmacovigilance teams to safeguard your programme and ensure the smoothest path to product approval.

Our in-house team can support with:

Global regulatory development strategy an...

Our regulatory services team has decades of experience in obtaining and maintaining market authorizations and registrations. We ensure compliance of medicinal products, medical devices and food supplements during their complete life cycle. Currently we obtain compliance in 55 countries worldwide. Contact ...

Regulatory Affairs Services & Life Cycle Management The regulatory services for human and veterinary medicinal products provided by i.DRAS GmbH cover the whole product life cycle. These activities range from preclinical development stages to the first submission of the MA dossier and post-marke...

The field of RA encompasses all the work necessary to manage products’ registrations and to receive and maintain marketing authorization.Choose PQE Group’s comprehensive support and broad strategic knowledge to launch products without delays and keep them on different worldwide markets.