The pathway to market is complex, but DLRC can simplify your journey. Operating from our UK, Germany, and US offices with over 1,000 years of combined experience, we collaborate with diverse clients, from top-five pharma companies to SMEs and start-ups. We develop and execute innovative phase-appropriate regulatory strategies to provide comprehensive support from very early in a product's lifecycle to post-licensing activities for medicinal products and medical devices.
Our team comprises consultant experts in non-clinical, CMC, clinical, and MedTech fields from pharmaceutical, medical device, and regulatory agency backgrounds. With a wealth of knowledge and experience, we have proudly served over 130 companies of all sizes and backgrounds in various regulatory jurisdictions.
Our service offering includes:
Strategy
• Global strategic advice
• Regulatory route to clinic/market
• Gap analysis & due diligence
• EU CTR: Implementation & transition planning
• Health authority engagement & negotiations
• Expedited pathways
• Paediatric development
Operations
• Procedural management: Global regulatory agencies
• Clinical trial applications
• Marketing authorisation
• Medical and scientific writing
• Regulatory operations and publishing
• Regulatory lifecycle management
Representation
• US agent
• Authorised representative medical devices
• Legal representative under EU CTR
• SME / ODD / MAH holder
Our unwavering commitment to excellence has earned numerous accolades and industry recognition, solidifying our reputation as a trusted name in the life science industry. These include King’s Award for Enterprise in International Trade, TOPRA Awards for Regulatory Excellence, ISO 9001 Accreditation, Investors in People Silver Award, Cyber Essentials accreditation, and Queen’s Award for Enterprise in International Trade.
Speak to us today to find out how our award-winning team can maximise the potential of your company and products.
Company Details
- Employees
- 107
- Founded
- -
- Address
- Suite 201, The Nexus Building,broadway,germany
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- http://www.dlrcgroup.com
- Keywords
- regulatory affairs, Clinical trial applications, Marketing authorisation applications, NDA's, MAA's, eCTD, DCP, MRP, EMA, FDA, Centralised procedure, Paediatric Investigation Plans (PIP)s, Scientific Advice, Orphan Drug Designations, IND, regulatory strategy, drug development, regulatory complaince, pharmaceutical regulations.
- HQ
- Letchworth Garden City, Herts
- Competitors
- ELIQUENT Life Sciences, Orphix Consulting GmbH, Advance Regulatory Consulting, Acorn Regulatory Consultancy Services Limited, Boyds, ProPharma, RApport Global Strategic Services, Medicines and Healthcare products Regulatory Agency, Scendea, TOPRA - The Organisation for Professionals in Regulatory Affairs.
Dlrc Regulatory Consultancy Questions
Dlrc Regulatory Consultancy's website is http://www.dlrcgroup.com
Dlrc Regulatory Consultancy's LinkedIn profile is https://www.linkedin.com/company/dlrcgroup
Dlrc Regulatory Consultancy has
107 employees.
View email and phone details for 107
employees at Dlrc Regulatory Consultancy.
Dlrc Regulatory Consultancy's industry is
Business Consulting and Services
Dlrc Regulatory Consultancy's top competitors are
Eliquent Life Sciences,
Orphix Consulting Gmbh,
Advance Regulatory Consulting,
Acorn Regulatory Consultancy Services Limited,
Boyds,
Propharma,
Rapport Global Strategic Services,
Medicines And Healthcare Products Regulatory Agency,
Scendea,
Topra - The Organisation For Professionals In Regulatory Affairs.
Dlrc Regulatory Consultancy's categories are Business Consulting and Services
Dlrc Regulatory Consultancy's founding year is 2005
