reserco

RESERCO SL

Veterinary Regulatory Services

ABOUT US

Reserco is a contract consultancy which offers Research and Development (R+D) services to veterinary pharmaceutical companies.

Focusing on providing expert advice in Regulatory Affairs and Project Management, it supports companies worldwide in European and International markets.

  • PRODUCT DEVELOPMENT
  • Support in submitting SME applications to European Authorities
  • Support in MUMS applications
  • Evaluation of GAP analysis
  • Product development plan (studies to be conducted, cost estimation, timelines)
  • Selection of partners (define activities and requirements)
  • REGULATORY AFFARIS
  • Regulatory strategies (MUMS, generics, innovative products)
  • Regulatory advice in CP, DCP, MRP and National procedures
  • Consultancy with regulatory authorities
  • Preparation of the Marketing Authorisation dossiers documentation
  • Preparation and submission of regulatory documents in vNeeS validated format
  • Quality, Safety and Efficacy Expert reports
  • Pre-submission meetings
  • Manage national and international applications for Marketing Authorization
  • Dealing with authorities questions
  • Follow-up of the procedure until its resolution
  • Variations and Renewals
  • Evaluate and update dossiers into current standards
  • Transfer and update paper based dossiers into new electronic format
  • Scientific Advice (request, assistance and defence)
  • MRL application dossiers
  • EFFICACY AND SAFETY STUDIES
  • Protocol elaboration and final studies reports
  • Residue studies
  • Tolerance in Animal Species (TAS) Studies
  • Pharmacokinetic and pharmacodynamics (PK/PD) studies
  • Efficacy field and controlled studies
  • Development of the pre-clinical and clinical trials
  • Monitoring of the trials
  • Regular contact with veterinaries/investigators during the study
  • CRO contract
  • PROJECT MANAGEMENT
  • Study outlines
  • Coordination of the development plan
  • Coordinate timelines for studies
  • Coordinate activities with other partners
  • Evaluation and Selection of suppliers for studies
  • Monitoring studies
  • Elaboration and review protocols
  • Elaboration and review of final study reports
  • Provide updates of the project status
  • Support solving problems
  • QUALITY SERVICES
  • Pharmaceutical development
  • Analytical development
  • Complete quality studies development
  • SERVICES FOR ALL TYPE OF STUDIES
  • Study design
  • Protocol Development
  • Import licenses
  • Selection of the site
  • Set up of Studies
  • Training of Study Participants
  • Monitoring of Studies including regular site visits
  • Statistical analyses and Interpretation
  • Final Study Report
  • GMP compliant Contract Manufacturing
  • Regular contact with sites during the studies
  • Consultancy of protocols and reports
  • CARE PRODUCTS
  • European Registration
  • European Variations and Renewals
  • Scientific advice
  • Contact with the competent authorities

RESERCO - RESEARCH and DEVELOPMENT

CO-WORKING

More than 20 years of experience. Contact with the European National Authorities, European Medicines Agency (EMA) and non- European countries agencies (Turkey, Russia, South Africa, Morocco). Contact with research institutes (CROs), veterinaries and experts to develop quality, safety and efficacy tasks.