Services

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.

Relationships:

We work in partnership with our colleagues, customers, and stakeholders to enhance positive working relationships based on trust and collaboration and believe in a one global team approach. We act fairly, ethically, honestly, openly and with professionalism, taking pride in our work and valuing the contribution of every individual.

Excellence:

We strive towards excellence in all that we do and are constantly looking at ways in which to demonstrate excellence to both our customers and colleagues. We encourage, recognise and champion the different levels of expertise within the company enabling us to always produce and deliver a quality product to both our external and internal customers.

Accountability:

We all demonstrate accountability and ownership for our work ensuring that we take personal responsibility for delivering results by following a process of seeing it, owning it, solving it and doing it.

Customer-Focus:

We look to add value to our external and internal customers by identifying their current and future needs and providing a service focused approach in all of our interactions.

Innovation:

We foster a work environment where creative thinking is encouraged and rewarded in order to create opportunities for process improvement and more cost-effective sustainable products and services, providing value to both Pike and our customers.

Quality:

We take pride in providing high value products and services that we stand behind, which ensures customer satisfaction, profitability and the future of our employees and our growth.