Regulatory Affairs

Recipharm offer a range of synthetic chemistry services through our global development facilities including advanced lead optimisation medicinal chemistry, process development and tech transfer to large scale GMP-manufacturing and other specialties.

Industrial Expertise

Technical and Scientific supports

Technical writing of Dossiers and variations

Post marketing authorization maintenance support Services 

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...

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 ...

e-Dox: management of eCTDs

OP Pharma has been providing innovative services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.

Do you have dossiers of which you would like to outsource the management and upda...

Rephine’s regulatory consultancy provides a complete portfolio of regulatory services to the pharmaceutical industry from clinical trial regulatory support to product life cycle management. Services include but are not limited to full clinical trial application (CTA) support, ful...

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...

Experts in management and assessment of the production of medicinal cannabis.

The regulation of the cultivation and production of cannabis derivatives favours the emergence of a new industry with a large global market .It is estimated that the market for medicinal cannabis could reach 50 b...

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

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 simula...

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 ...

WuXi STA's dedicated Global Regulatory Affairs CMC Team offers CMC documentation support for IND, CTA, MAA, and NDA applications in western countries and China. Our highly experienced team works with your NCE programs to prepare Module 2 and Module 3 of your regulatory dossier through forward-looking gap anal...

Recipharm offer analytical support for drug discovery, pharmaceutical development and manufacturing through our global development facilities.

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.

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.

OP Pharma has been providing all-around services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.

Do you have lots of products and/or products' data which you cannot organize/archive internally...

OP Pharma has been providing innovative services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.
Our expertise covers the lifecycle management of pharmaceutical products, whole or in part, ranging from digitization of ...

OP Pharma has been providing all-around services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.
Our expertise ranges from submission of registrations, variations, prices, texts, renewals (also via CESP), to CEP and DM...

Over 400 developed recipes, 
including over 50 medical devices in various classes and indications,
in 20 pharmaceutical forms - 
everything starts in the Gofarm's R&D Laboratory.



In Gofarm's R&D Laboratory our and our clients' ideas take real shapes. q...