Regulatory Affairs
Regulatory Affairs Companies (36)
Regulatory Affairs News
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News CPHI Podcast Series: Success in healthcare M&A, taking a people-first approach
Global mergers and acquisitions hit an all-time high in 2021, and in the life sciences industry these kinds of deals show no sign of slowing down. -
Sponsored Content Size doesn’t matter: How smaller deals are shaping healthcare M&A
Several mega-deals have made a splash in the pharma and life sciences industries over recent years – from AstraZeneca’s acquisition of Alexion for $39 billion to Gilead Sciences’ $21 billion purchase of Immunomedics. With am... -
News Drugmakers pledge faster, more equitable medicine access in Europe
Drugmakers have agreed to speed up the market launch of new drugs in underserved EU member states as an alternative to stricter regulation. -
Sponsored Content Audits in the time of COVID-19 – Implications for a CMO
Travel restrictions imposed by the pandemic have limited the ability of pharmaceutical companies and health authority personnel to travel and conduct in-person inspections of contract manufacturing organizations (CMOs). Due to t...
Regulatory Affairs Products (32)
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Product Synthetic Chemistry
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. -
Product Technical & Regulatory Services
Industrial Expertise
Technical and Scientific supports
Technical writing of Dossiers and variations
Post marketing authorization maintenance support Services
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Product Pediatric Development
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... -
Product Regulatory Services
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 ... -
Product e-Dox: management of eCTDs
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... -
Product Regulatory Affairs Support Services
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... -
Product Regulatory services
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... -
Product Medical Cannabis Consulting
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... -
Product Medical & Regulatory Services - Inhaled Products
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... -
Product Wasdell QP Services
Our dedicated QP Services team are able to provide compliance support, audit services, regulatory consultancy and QP certification for imported medicinal products. -
Product Development and engineering services by GEMÜ
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... -
Product Research & Development and Regulatory Affairs
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 ... -
Product Global Regulatory Affairs CMC
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... -
Product Analytical Development
Recipharm offer analytical support for drug discovery, pharmaceutical development and manufacturing through our global development facilities. -
Product Formulation Development
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. -
Product Clinical Supply
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. -
Product e-Reg: management of Regulatory Affairs' big data
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... -
Product IT/EU REGULATORY AFFAIRS - Support and management of Technical documentation and eCTD
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 ... -
Product IT/EU REGULATORY AFFAIRS - Support and management of RA practices
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... -
Product R&D Laboratory of medical devices
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...
Upcoming Events
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28 - 30 September 2022 -
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Messe Frankfurt, Frankfurt, Germany
1-3 November 2022 -
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India Expo Centre, Greater Noida, Delhi NCR
29 November - 1 December
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