Regulatory Affairs

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 t...

Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.

Project resource management includes forecasting the need to hire and/or outsource some tasks. When projects are high-value and require strategic decisions, in-house resources may be insufficient. Similarly, administrative action items are better left to contract workers so as to not overburden your staff....

Debt collection activities all over the world: we support Top European Pharma Groups, with extra-performances

GEMÜ engages with its customers at an early stage and supports them in all aspects of product development. From conceptual design, mould engineering, material consulting to sterilization and regulatory support, we can provide all competencies in-house. In addition, our developments are supported by sim...

Thépenier Pharma & Cosmetics offers comprehensive regulatory affairs and compliance services to ensure that all products meet global pharmaceutical standards. From dossier preparation to liaising with health authorities, the team ensures smooth regulatory approval processes. With expertise in GMP, ISO ...

With the growth in pharma manufacturing capability in Asia, each manufacturer nurtures an ambition to have their own footprint in the EU market.

PharmSol, with its own setups in Germany and Malta, has created a platform which provides a comprehensive, integrated and seamless market access and su...

We provide a complete and comprehensive range of services from A to Z for substance-based  medical devices: from product idea, through development and research, certification, registration and product delivery to the customer.

With us, you can easily launch a new substance-based ...

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 cust...

Synerlab provides wide range of services which includes development. Contact us for more information.

Increase successful submission outcomes in markets worldwide with comprehensive, expertly analyzed regulatory and market access information 1. Get treatments to patients faster Compare and monitor regulations quickly across markets to understand regional health technology assessment (HTA) outcomes. 2. Main...

Our experienced HSE experts offer various health, safety and environment services: Safety data sheet (SDS) support (SDS classification, labelling) in most EU languages, including online access and QR links; Controlled substances, precursors, highly active substances and other restricted chemicals (in-clud...

SUPPORT SERVICES FOR OUR CONTRACTED CUSTOMERS • Analytical Development • Validation Support • Regulatory Support • Clinical Supply Services

Avéma Pharma Solutions can help guide your product successfully through NDA, ANDA, CBE 30 and 505(b)(2) filings with the FDA.

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/E...

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...

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 ...

NDA/ANDA MAA-CTD writing Regulatory support

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...

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. Conta...