Orbital Regulatory Affairs

Regulatory affairs for human and veterinary pharmaceuticals

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With more than 20 years of experience and in contact with national and European authorities(European Medicines Agency) and various agencies outside the EU (Turkey, Russia, South Africa and Morocco).

Orbital Regulatory Affairs offers a complete regulatory affairs consulting service for the human and veterinary pharmaceutical industry*.

Our advice begins in the research phase and includes registration, efficacy and safety studies and project management, among others. Our services can be contracted on a comprehensive or ad hoc basis depending on the specific needs of the client in each of its markets.

* Formerly under the Reserco brand and currently within the Regulatory Affairs division of Orbital Pharma.

Auditing, certification, validation, calibration and training

Services

Orbital Pharma offers a wide range of qualification services, either on an ad hoc basis or as part of a comprehensive project:

  • Support for the submission of EMS applications to European Authorities
  • MUMS application support
  • Evaluation of the GAP analysis
  • Product development plan (studies to be carried out, cost estimates, timelines, etc.)
  • Partner selection (define activities and requirements)
  • Regulatory strategy (MUMS, generics, innovative products)
  • Regulatory advice on CP, DCP, MRP and National procedures.
  • Consultation with regulatory agencies
  • Preparation of marketing authorization dossier documents
  • Preparation and submission of regulatory documents in a format validated by vNeeS
  • Quality, Safety and Efficiency
  • Pre-presentation meetings
  • Manage national and international marketing authorization applications.
  • Handling of questions from the authorities
  • Follow-up of the procedure until its resolution
  • Variations and Renewals
  • Evaluate and update dossiers to current standards
  • Transferring and updating paper records in a new electronic format
  • Scientific Advice (application, assistance and defense)
  • MRL application files
  • Request for scientific advice to the Spanish Agency for Medicines and Veterinary Products (AEMPS) and the Committee for Medicinal Products for Veterinary Use (CVMP).
  • Pharmaceutical development
  • Analytical development
  • Complete development of quality studies
  • Elaboration of Protocols and Final Reports of studies.
  • Waste studies
  • Tolerance Studies in Animal Species (TAS)
  • Pharmacokinetic and pharmacodynamic studies (PK / PD)
  • Field efficacy studies and controlled studies
  • Development of preclinical and clinical trials
  • Follow-up of trials
  • Regular contact with veterinarians/researchers during the study
  • CRO Contract
  • Realization of test diagrams
  • Coordination of the development plan
  • Coordinate study deadlines
  • Coordinate activities with other partners
  • Evaluation and selection of suppliers for studies
  • Follow-up studies
  • Review and development of protocols
  • Review and preparation of final study reports
  • Updating of projects
  • Problem solving support
  • Study design
  • Protocol development
  • Import licenses
  • Site selection
  • Establishment of Studies
  • Training of study participants
  • Follow-up studies including regular site visits
  • Statistical Analysis and Interpretation
  • Final study report
  • GMP-compliant Contract Manufacturing
  • Regular contact with the sites during the studies
  • Protocol consulting and reporting
  • European Registry
  • European variations and renovations
  • Scientific advice
  • Contact with the competent authorities
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Contact us:

Bruc Street, 64
Low. Local 3
08009 Barcelona (Spain)
+34 93 252 02 20
info@reidesen.com

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