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Regulatory affairs

When you are dealing with the different regulatory requirements around the globe relating to all phases of your product’s approval and marketing, you want to work with the most highly qualified, experienced and approachable team you can find. After all, you are under pressure from the regulators. You want a confident partner at your side.
 
Envigo’s regulatory affairs team is equipped with the knowledge and skills to provide your company with a comprehensive understanding of current regulatory guidelines and procedures. Our experienced consultancy group provides practical advice and support to our drug development customers in moving products from early concept to marketing authorization. With a proven track record of success across the world, we can help you throughout the entire lifecycle of your product to achieve your goals in a fast, low risk and efficient manner. With offices in the UK, US and Japan, we provide regulatory services throughout the International Conference on Harmonization (ICH) regions, and we can offer a global regulatory service through our affiliations in other non-ICH regions.
 
Nonclinical/Phase I Phase II Phase III Licensing Post-approval
Due diligence evaluation* Paediatric investigation plan Additional CTA / IND maintenance Labeling* Core data sheets / Post-marketing labeling
Agency meeting* End of phase II agency meeting Expedited program / Fast track application Pre-submission meetings License variations 
Scientific advice / pre-IND Drug master file MAA / NDA / BLA preparation filing Renewals
Orphan drug designation Conditional MAA Responses to agency questions Line extensions
IB/IMPD writing* Special protocol assessment National /  CP / MRP /  DCP MAA Submissions to additional countries – MRP/DCP
CTA/IND submission* EudraCT posting*
PRIME / SME status  
*applicable to multiple phases
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  • Preparation of marketing authorization applications, clinical trial authorization applications and INDs
  • Preparation of requests for scientific advice from FDA, EMA and EU national authorities
  • Support for customers in Regulatory Authority meetings; advice on regulatory strategy; due diligence on existing data packages
  • Preparation of orphan drug designations in EU and US, pediatric investigation plans and drug master files
  • Advice on regulatory requirements for individual studies, taking into account product type and therapeutic class, and review and interpretation of study data
  • Regulatory support for the development of devices, drug/device combinations and borderline products.
  • Clinical trial legal representative services for non-EU companies and US Agent services for non-US companies

Products:

We work with a full range of medicinal products including new chemical entities (NCEs), biologics, advanced therapies and generics. We have experience with the following product types:
  
  • Small molecules
  • Protein-based therapeutics
  • DNA-based therapeutics
  • Drug delivery systems
  • Re-profiled known active pharmaceutical ingredients (APIs)
  • Generics
  • Drug-device combinations
  • Herbal medicines
We can maximize the success of your product by assisting you with non-clinical and clinical support:
  
  • Due diligence
  • Agency and working party meetings e.g., ITF meeting
  • Scientific advice / protocol assistance
  • CTA / IND applications and maintenance
  • Pediatric investigation plans
  • Orphan drug designation
  • Fast track applications / special protocol assistance
    • marketing authorization applications
  • Pre submission meetings
  • MAA/NDA/BLA preparation and filing
  • eCTD and NeeS submissions
  • Drug master files
  • Responses to agency questions
    • Post marketing approval
  • License variations
  • Renewals
  • Line extensions
  • Submissions to additional countries
  • Product maintenance

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