Regulatory Affairs
Regulatory Affairs Companies (64)
Regulatory Affairs News
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News Women in Pharma: Regulating equity across regional borders
In our monthly series focusing on women in the pharmaceutical industry, we interview leading experts in the pharmaceutical supply and value chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News Updated – Changing abortion pill access according to the US FDA and Supreme Court
After the approval of the medical abortion pill, mifepristone, by the US FDA, states across the USA approach the distribution of the pill differently, some ruling against allowing access to the drug. -
News A Day in the Life of a Head of Quality Assurance and Regulatory Affairs
We are continuing to get to know the people working day-to-day behind the pharma companies shaping the industry, the ones who keep the wheels turning and ultimately bring better healthcare to the population; we are talking to the individuals at the hea... -
News Eisai begins US FDA rolling submission for Alzheimer’s drug Leqembi
Japanese drugmaker Eisai, in partnership with Biogen, have announced that they have begun submitting data on a rolling basis to the US FDA for a marketing application of a subcutaneous injectable form of Alzheimer’s drug Leqembi.
Regulatory Affairs Products (53)
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Product Biologic drug substance CDMO services
From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i... -
Product Scientific Support
Selectchemie AG provides a wide range of services including scientific support. Our experienced professionals are at your service at locations in 18 countries to deliver tailor-made solutions according to your needs. Contact us for more information. -
Product CordenPharma Drug Product Support Services
SUPPORT SERVICES FOR OUR CONTRACTED CUSTOMERS • Analytical Development • Validation Support • Regulatory Support • Clinical Supply Services -
Product Pharmaceutical drug substances (APIs)
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... -
Product Hi-End Resource On Demand Solutions
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.... -
Product Regulatory & Market Access
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 supply c... -
Product Regulatory affairs services
I. SERVICES 1. Submission of ANDA, NDA and IND applications with NMPA; (including the whole service from GAP analysis, compiling, submission, sample testing, CDE review procedure tracking and supplemental info preparation); 2. GAP analysis and application strategies setup before the submission to NMPA; 3. ... -
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 Commercialization Services
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... -
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 ... -
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... -
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. Conta... -
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 interna... -
Product Marketing Authorization : "Exploitation" Hosting and Maintenance
MEDIPHA SANTE offers a wide range of services which include:
StrategyCompliance with the requirements for every type of variation
Preparation of supporting documents
Submission of variations according to the appropriate procedure
Renewals
Pharmacovigilance (Medipha Santé can provide ... -
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 sim... -
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 devic... -
Product Sampling devices
• For powder sampling • For liquid sampling • For semi solid sampling • For pellet sampling • For thick semi solid sampling • For mups sampling • For suppository sampling -
Product Health, Safety and Environment Services
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... -
Product CEP Dossier Applications and Revisions
Our team of experienced RA experts offers API manufacturers various levels of support for new CEP dossier applications and subsequent revisions. This can include all or some of the following services: gap analysis, dossier improvement, submission, deficiency support, meeting with EDQM. Contact us for mor...
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