RegPak Strategic Planning Service for Product Approval

RegPakBioPharma Consulting’s high quality consultancy services include a Strategic Planning offering that assists clients to develop new products, speed regulatory approval and reduce time to market.

The service leverages RegPak’s expertise in many therapeutic areas, including oncology, autoimmune diseases, cardiovascular, CNS, dermatology and infectious diseases. It includes all the key expertise and processes required to satisfy regulatory requirements and smooth the way to market approval for biologicals (including biosimilars), vaccines, small molecules, generics, cosmeceuticals, nutraceutical/herbal products and medical devices.

Market Approval Expertise

• Regulatory intelligence & expert knowledge of global regulatory requirements
  • European and Non-European scientific advice and pre-submission meetings includingFDA compliant pre- Investigational New Drug Application (IND), pre- biologics license application (BLA), End-of-Phase (EOP) 2&3, Oral explanation meetings. and initial Pediatric Study Plan (iPSP) and Pediatric Investigation Plan (PIP) procedures
  • Clinical Development Plans and Labelling, including Company Core Data Sheet (CCDS), Target Product Profile (TPP), Investigational Medicinal Products Dossier (IMPD), and Regional Manufacturing Documents
  • Various modules for Marketing Authorization Application (MAA)and License Maintenance, including variations
  • Clinical Trial Authorization(CTA) Applications
  • Orphan Drug Designations
  • Named Patient/Early Access Programmes
  • CE Marking and device investigational studies
• Trial Support for BioPharma& Medical Device Companies
  • Clinical trial applications + substantial amendments- Global local consultant network
  • Clinical Trial Documentation Authoring
  • Protocol Assistance
  • Investigator’s Brochure
  • Informed Consent Forms
  • Site Selection & Clinical Trial Monitoring
  • Clinical Project Management
  • Independent Data Safety Monitoring Committee set-up
  • Safety Reporting
• Pharmacovigilance
  • European (Deputy) Qualified Person for Pharmacovigilance (EU QPPV/Deputy QPPV)
  • Establishment of risk minimization plans, pharmacovigilance planning and assessment of benefit vs. risk
  • Safety report exchange with EMA’s EudraVigilance electronic reporting system
  • Alignment of Patient Information Leaflets
  • Pharmacovigilance Audits
  • Assistance with Pharmacovigilance Inspections
• Product Promotion & Labelling
  • Development and maintenance of CCDS, including global prescribing information (PIL)
  • Review and approval of safety variations impacting label/prescribing information
  • QC check for compliance with appropriate Quality Review of Documents (QRD) template
  • Compliance with advertisement and promotion in EU & Non-EU countries
• QA & Inspections
  • Ensuring effective and robust compliance to quality in all aspects of the site operations and releases
  • Formulating change control procedures, review batch records, gap analysis and formulate corrective actions
  • GLP and GMP audits/Inspections
• Due Diligence
  • Conduct of regulatory due diligence on new product opportunities
• Pricing and Reimbursement
  • Developing and executing pricing and reimbursement strategies for new products as well as refining strategies for in-line products
• Technical Writing
  • Target Product Profile
  • Clinical Development Plan
  • Investigational Medicinal Products Dossier (IMPD)
  • Pharmacovigilance Planning
  • Risk Assessment and Risk Minimization Plan
  • Benefit and Risk Assessment
  • Annual Safety Updates
  • Periodic Safety Update Reports
  • Briefing Book for Scientific Advice
  • Summary of Product Characteristics (SmPC)
  • Package and Label

About RegPak

RegPakBioPharma Consulting (RegPak) is a full-service consulting company based in The Netherlands and Romania. RegPak offers a consultancy that adapts to new demands, business pressures. with understanding of clients’ current and future needs.

RegPak applies its expertise in practical and logical ways to help companies worldwide, continually striving for excellence and sharing its principles and practices through training, presentations and publications. It develops services and creative offerings that provide new and more efficient ways for clients, their vendors, suppliers, and service providers to conduct their businesses within regulatory compliance and with reduced risk.

RegPak approach is interdisciplinary, with a strong emphasis on the science underlying the product. It also prioritizes client confidentiality and assured security of data. As an independent organization, RegPak avoids all conflicts of interest.

Resources

Click on Strategic Planning for Product Approval  for detailed information.