Regulatory Affairs

Drug development to commercialization of product involves multiple steps to be comply as per global regulatory authority requirements. We, RegEnd Solutions will provide the best comprehensive Regulatory services across the spectrum from development to commercialization for any health authority.

RegEnd Solution enable Regulatory services for Drug substance, Drug product (of any dosage form), over the counter (OTC), Food product, Herbal product.

USA

• Pre-submission:
  • Controlled correspondences
  • Meeting requests with agency
  • Pre-submission activities like (facility identification, request for DUNS/FEI /ANDA Application numbers)
  • Gap analysis of source data for dossier compilation/preparation
• Submission Phase:
  • Application submission (505j,505(b)(1),505(b)(2))
  • Preparation, review and submission of applications in line with refuse to receive (RTR) requirements.
  • Structured Product Labelling (SPL) preparation and review
  • Submission management through FDA ESG portal
• Post Approval Phase:
  • Transfer of ownership application
  • Any changes to existing Dossier – Annual Report Filling
  • Change being effective in 0 Days – CBE0
  • Change being effective in 30 Days – CBE30
  • Prior approval supplement – PAS

EUROPE and United Kingdom:

• Pre-submission:
  • Dossier submission strategy
  • Scientific advice
  • Reference product evaluation
  • Bioequivalence/Bioavailability support
  • Due diligence support
  • Product information preparation (QRD)
  • Orphan drug registration
  • Brexit support
• Submission Phase:
  • Review, Preparation and Submission of MAA (MRP/DCP/CP/Reliance/RUP/Duplicate)
  • Regional guidance/support as and where applicable.
  • eCTD preparation and publication.
  • National phase management.
• Post Approval Phase:
  • Variation support (Type IA/IB/II)
  • Line extensionapplication
  • Labelling management
  • MAT application
  • Sunset clause application
  • Renewal application

Global Regulatory Support

• Gap analysis/due-diligence dossier
• Dossier preparation (CMC/Medical writing / Clinical document)
• Labelling, Package Leaflet, Artwork
• COPP applications
• Lifecycle management

Publishing and Submission

Submission in electronic format becomes the mandatory tool for all regulated countries along with some of semi regulated countries.

RegEnd ensures error free Regulatory submission with utmost quality for each region wise specific requirement and format.

Regulatory strategy

RegEnd solutions provides end-to-end Regulatory solutions and services.

With good understanding of global life science industry and regional Regulatory pathway, RegEnd assist organizations to define successful strategies for different Regulatory authority submission to get quick market approvals.

Regulatory medical writing

Medical writing is a critical segment of clinical research. With a team of experienced medical writing professionals from pharmaceuticals and clinical research industries, RegEnd provide quality clinical documents in described format by Regulatory authority.

Regulatory labelling

RegEnd has qualified personals who prepare and review of product labelling requirement for submission to the Regulatory authority.