• Accelerate your services with
    Innovative Technology
    See what we can do for you
  • Accelerate your services with
    Innovative Technology
    See what we can do for you
  • Accelerate your services with
    Innovative Technology
    See what we can do for you

Why

Mitocon Biopharma

One of the world's leading Pharma company.

Mitocon Biopharma is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments and we are always coded to care. From clinical trials to regulatory, technical, and functional ability is underpinned by a deep conviction in what we do, “this is our commitment to bringing medicines to patients faster through the provision of high quality data capture, analysis and reporting”.

Our global pharmacovigilance team is comprised of physicians, pharmacists and other medically trainedprofessionals.

Our Vision

Experienced Team

With a panel of highly experienced medical review safety physicians, we possess the abilities to handle physician projects as well, with the assurance that the highest quality levels are maintained.

Data Security

We bring a lot of energy and dynamism to the table, Your data confidentiality is our highest priority. Therefore, our business model ensures that your data with us is as safe as it is when it is with you.

Great Support

With years of pharmacovigilance, medical and management experience we believe in Quality Support, Out team ensures that we meet stringent deadlines with expert 24/7 Service

Key areas of Expertise

These Skills Differentiate Us with the Rest

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;