Regulis Consulting Ltd

Regulis Consulting Ltd is a pharmaceutical consultancy that offers expertise in the areas of Regulatory Affairs, Pharmacovigilance and Quality Assurance across the globe.  From the strategic to the operational, Regulis guides clients through the regulatory maze to:

• Get products licensed and to market as quickly and efficiently as possible
• Enhance the value of products with seamless compliance
• Protect patients and the value of products

Regulis has a proven track record of increasing revenue, decreasing risk and reducing costs for our clients.

Our team of high calibre scientists have a strong reputation for obtaining fast, high quality product approvals, pharmacovigilance risk management and GMP/GDP compliance.  Regulis was founded in 2001 and is now a leading consultancy company with vast experience of working with pharmaceutical, medical device and borderline substance companies, helping them grow.

We have a strong sector focus with a 'regulatory' core but we're not just about the rules!  Our strength is taking the time to understand your project or product and your goals and then constantly demonstrating creativity and commercial focus in the regulatory arena to overcome obstacles to grow.

Pharmaceutical companies all over the globe rely on Regulis to speed their products to market and then to protect and enhance the value of their product assets.  With strategic to operational reach, we design and optimise strategy and execute it smoothly, efficiently and quickly using our methodologies.

Availability for Work

Australasia, Europe, Middle East, PAC, Scandanavian Countries, UK and Worldwide

Areas of Expertise

Advanced therapies, Audit - Pharmacovigilance, Audit - Post-marketing PV, Clinical Overviews, Compliance Advice, Compliance Remediation, Development Safety Update Reports, Due Diligence, GCP Auditing, Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), IMP QP, ISO13485, ISO13485 compliance for Medical Devices, In Vitro Diagnostic Devices, Inspection Preparation, Inspection Preparation, Support and Management, Medical Devices, Pharmacovigilance (GVP), Pharmacovigilance (PV), QP Services, Regulatory, Regulatory Affairs, Regulatory Responses, Risk Management Plans, SOP Writing, Safety Data Migration, Safety Database Management, Safety Query Responses, Standard Operating Procedures (SOPs), Summary of Clinical Efficacy Reports, Summary of Clinical Safety Reports

Contact Details

1st Floor, St Peter's House, Market Place, Tring, HP23 5AE

Email: enquiries@regulis.com

Website: www.regulis.com

 

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