Regulatory Affairs
Regulatory Affairs Companies (49)
Regulatory Affairs News
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News UK Medicines Agency receives injection of £10 million to expedite medicine approvals
The HM Treasury in the UK has announced that they will be awarding the Medicines and Healthcare Products Regulatory Agency (MHRA) with £10 million to expedite the generation of new medicines for UK patients. -
News Open letter challenges EU Commission on medicine supply chain
In an open letter to the European Commission, Medicines for Europe calls for a new medicine security contract with their goal to improve access to medicine and ensure a secure supply chain to Europe. -
News Gilead Sciences’ breast cancer drug receives US FDA approval for third indication
Trodelvy, an antibody–drug conjugate with indications against certain types of cancer, has been approved by the US FDA for a third indication against pre-treated HR+/HER2- metastatic breast cancer. -
News UK creates new regulations to achieve more accessible care
The UK Medicines and Healthcare products Regulatory Agency have approved an innovative framework to enable seamless use of Point of Care products that will benefit patients.
Regulatory Affairs Products (40)
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Product Services
Our specialist analytical, laboratory and regulatory services add value at every stage of the drug development process, accelerating and de-risking program along the way. -
Product Regulatory Support
Avéma Pharma Solutions can help guide your product successfully through NDA, ANDA, CBE 30 and 505(b)(2) filings with the FDA. -
Product Consulting: Quality Management System
Quality management systems (QMS) are crucial for the success of any business. They provide an accurate way to track and measure quality across all areas of your company. One key benefit of a quality management system is that it establishes clear goals, roles, and responsibilities. It also tracks the pr... -
Product GBC Production Plant site Video
Genovior Biotechnology Corporation facility capabilities & current ongoing production lines -
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... -
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 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 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, ... -
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 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 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 Consulting: ICH Q10
Pharmaceutical companies must be capable of delivering products to the market with the utmost level of quality and safety. At Zamann Pharma Support, we have been aiding large and mid‐sized pharmaceutical companies in solving quality and compliance challenges while ensuring that practicality and qualit... -
Product Life Science: GMP Process Support
The compliance environment of the pharmaceutical and life science industry can offer very complex challenges. One issue is optimizing workplace technologies in the areas of Business Process Changes, Validation, and general GxP Compliance. At the same time, these challenges must be balanced with the develop... -
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 ... -
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 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 u... -
Product Registration of Pharmaceutical products in Singapore
We support clients to manage their regulatory portfolio in Singapore and other parts of SE Asia by rendering independent license holding, submission of dossier to health authority, regulatory intelligence works and project management.
Upcoming Events
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CPHI Japan 2023
Tokyo Big Sight, Tokyo, Japan
19 - 21 April 2023 -
CPHI North America 2023
Pennsylvania Convention Center, Philadelphia
April, 25-27, 2023 -
CPHI & PMEC China 2023
Shanghai New International Expo Center
19 - 21 June 2023
Pharmaceutical Industry Webinars
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