We provide CRO services and pride ourselves in putting your company's needs first and adding value to whatever we do. We employ Lean principles in our strategy and by being science-led we share the passion with the scientific, healthcare and business communities in the UK.
As a group of Regulatory, QA and Pharmacovigilance consultants we offer an array of services for small to medium-sized pharmaceutical companies. As the regulatory landscape is ever changing that extra help may be just what you need.
-Regulatory Affairs: from Registration throughout Lifecycle maintenance.
-Publishing: eCTD authoring
-Pharmacovigilance: QPPV services, PSUR compiling and post-marketing monitoring
-Tracking of regulatory changes and provide updates applicable to Client’s product applications.
-Provide submission services to regulators and Competent Authorities worldwide, electronically wherever possible, through hosted production and document management systems.
-Prepare and submit updates to the Summary of Product Characteristics (SmPC), patient information leaflets, and product labelling.
-Complete response to questions received from Health Authorities, particularly those related to product safety that may arise from PSURs and other reports submitted
-Life-cycle submissions and managing agency queries
-Affiliate service provision
-Publishing capability
Company Details
- Employees
- 7
- Founded
- -
- Address
- 85 Great Portland Street, London,england W1w 7lt,united Kingdom
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Keywords
- Regulatory Affairs, Quality Assurance, eCTD, Pharmacovigilance, GDP, Publishing, Audits, PQR compiling, Consultancy, Business Development, MAA, Variations, MAH transfers, Audits, Courses, Publishing, Consultants.
- HQ
- London, England
- Competitors
- TOPRA - The Organisation for Professionals in Regulatory Affairs, Regulatory Affairs Professionals, Regulatory Affairs and Quality Assurance Graduate Program - Temple University School of Pharmacy, Acorn Regulatory Consultancy Services Limited, Regulatory Affairs Consulting - IRIS GLOBAL LLC, Regulatory Affairs Crash Course (RACC), Regulatory Affairs, RADEX - Regulatory Affairs, Regulatory Connect, Regulatory Affairs Professionals Society (RAPS).
Regulatory Affairs Hub Questions
Regulatory Affairs Hub's website is http://www.regulatoryaffairshub.com
Regulatory Affairs Hub's LinkedIn profile is https://uk.linkedin.com/company/rah-regulatory-affairs-hub
Regulatory Affairs Hub has
7 employees.
View email and phone details for 7
employees at Regulatory Affairs Hub.
Regulatory Affairs Hub's industry is
Pharmaceutical Manufacturing
Regulatory Affairs Hub's top competitors are
Topra - The Organisation For Professionals In Regulatory Affairs,
Regulatory Affairs Professionals,
Regulatory Affairs And Quality Assurance Graduate Program - Temple University School Of Pharmacy,
Acorn Regulatory Consultancy Services Limited,
Regulatory Affairs Consulting - Iris Global Llc,
Regulatory Affairs Crash Course (Racc),
Regulatory Affairs,
Radex - Regulatory Affairs,
Regulatory Connect,
Regulatory Affairs Professionals Society (Raps).
Regulatory Affairs Hub's categories are Pharmaceutical Manufacturing
Regulatory Affairs Hub's founding year is 2018
