Our Services
Mitocon Biopharma is a global contract research organization serving the pharmaceutical, biopharmaceutical, medical device, and consumer healthcare industries. By offering high quality, value-add client specific solutions to meet current and future development needs
MEDICAL DEVICE VIGILANCE
• Medical device consultancy and project management • Safety data management and global safety database • Adverse device effect (ADE) and medical device incident (MDI) case processing, coding and follow-up. • Case narratives • Device Vigilance Report preparation and submission • Medical assessment • Adverse Device Effect (ADE)/ Medical Device Incident (MDI) trending and evaluation • Literature search and review • Vigilance Quality Assurance including SOP development • Monthly compliance and status reporting • ADE and MDI reconciliation • Periodic Reporting: Development Safety Update Reports (DSURs), IND Safety Reports, Periodic Safety Update Reports/Periodic Benefit Risk Evaluation Reports (PSURs/PBRERs), and Periodic Adverse Drug Experience Reports (PADERs).
STRATEGIC REGULATORY AFFAIRS
Mitocon assists Life Sciences organizations to streamline entire Regulatory submissions management process, right from dossier development, submission planning, tracking, publishing and final submissions to Health Authorities (HAs) including delivery confirmation/acknowledgement.
We expertise in;
• Structured product labelling service
• Preparation and submission of final dossier preparation, compilation and filling (ANDAs, NDAs)
• Efficiency response management
• Database support activities
PRODUCT SAFETY & PHARMACOVIGILANCE
• Book in, Triaging & 24/7/365 Case Management Support.
• Data entry into validated electronic PV database.
• 100% Quality control of all ICSR including medical QC.
• Medical review and assessment, narrative writing, MedDRA coding, Causality Assessments
• Product Quality Complaints Management.
• Reporting & Submissions: Electronic (E2B), Hard copy (CIOMS, MedWatch 3500A drug, etc.) to worldwide regulatory authorities.
Clinical Monitoring Services
Our flexible and dynamic operational model, utilizing experienced, knowledgeable and well trained local Clinical Associates allows us to deliver on even the toughest challenges. That’s why our clinical monitoring services stand out in our industry.
QUALITY COMPLIANCE MATRIX
Mitocon provides Regulatory Quality Compliance services that involve evaluating your requirement and suggesting inputs to the business processes that are designed to assure customer satisfaction as well as compliance. With uniquely designed in-house and on-demand compliance best practices and Regulatory compliance management, Mitocon ensures compliance and regulatory requirements such as the following;
Our Experts
Our people will only be passionate about offering excellence if they are working in an environment that promotes it. As such, Medsaf has put in place a number of workplace initiatives to actively encourage our employees to be actively engaged in our business. As part of this, Medsaf is actively: • Hiring and developing a highly skilled and motivated team • Ensuring that employees have the opportunity to grow and develop along with company • Providing opportunities to improve skills and working environment • Ensuring open, honest and proactive communication at all levels • Looking at ways to promote and identify opportunities for recognition • Constantly looking at ways to provide the best to our clients
Our Core values:
Mitocon biopharma offers a wide range of pharmacovigilance , regulatory, scientific and business services for global clients. We conduct clinical trials including study preparation, study conduct, medical coding, and medical review and Drug Safety Officer (DSO) activities. Depending on the contractual obligations, the staff at 3R biopharma may take over a part or the complete responsibility for any medical or safety-related issues.
