Comprehensive Contracting Solutions
At The MedPharma Contractors Ltd, we provide comprehensive contracting solutions to protect and enhance your value in today’s dynamic risk environment. Based in Dublin & Cork, Ireland, and established in 2019, our specialized services cater to the unique needs of the Life Sciences industry.
Why Us?
Bringing Products to Market
Translating data and research to address specific needs, we navigate the unique demands of health plans, healthcare providers, and patients. Our market access strategy and support services assist companies in executing evidence generation plans, analyzing market intelligence, pricing strategy, and facilitating payer outreach communication.
Supporting Commercial Needs
Whether you are an emerging company bringing your first product to market or an established company with multiple therapies, our team can help you navigate the commercial and medical needs of your product and business. From commercial enablement to government and commercial pricing and contracting, we are here to help.
Medical Affairs & Scientific Strategy
Our medical affairs solutions help life sciences companies develop and execute scientific and evidence generation plans throughout the product life cycle. We further support the value of life sciences products through philanthropy and external funding program design and patient support and advocacy.
Validation
At The MedPharma Contractors Ltd, we understand the critical importance of validation in the Life Sciences industry. Our specialized consultants are experts in ensuring compliance and quality across various stages of product development and manufacturing. Here’s how we provide validation:
GMP (Good Manufacturing Practice)
Ensuring products are consistently produced and controlled according to quality standards.
FDA Compliance
Meeting the stringent requirements set by the Food and Drug Administration.
Process Validation
Confirming that a process consistently produces a result meeting predetermined specifications.
IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification)
A systematic, documented verification process for equipment and systems.
Summary Reports
Comprehensive reporting to document validation processes and results.
Laboratory Equipment Validation
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Ensuring that lab equipment meets the required standards and specifications.
QA (Quality Assurance)
Implementing systematic activities to ensure quality requirements are fulfilled.
Cleaning Validation
Confirming that cleaning processes effectively remove residues to a predetermined level.
Audits
Conducting internal and external audits to ensure compliance with regulatory requirements.
CQV and Software Validation
Validating computerized systems and software to ensure accuracy, reliability, and consistent performance.
At The MedPharma Contractors Ltd, we understand the critical importance of validation in the Life Sciences industry. Our specialized consultants are experts in ensuring compliance and quality across various stages of product development and manufacturing. Here’s how we provide validation:
Supply Chain Resilience
We assist companies in mitigating risks by evaluating supply chain strengths, correcting weaknesses, and realigning operations to support strategic objectives. Our team is equipped to deal with unplanned disruptions, ensuring flexibility and responsiveness.
Governing Evolving & Complex Risks
Life sciences companies face the challenge of identifying, isolating, and measuring risk.
Our solutions include:
- Enterprise Risk Management (ERM)
- Internal Audit
- Investigations and Litigation Support
- Third-Party Risk Management & Due Diligence
- Data Privacy & Protection
We ensure proper governance and controls to protect your brand value.
Regulatory Support & Operational Integrity
Operating in a heavily regulated environment, we work with clients to ensure compliance with local, federal, and international regulations. Our team of compliance and ethics specialists ensures operational integrity and adherence to all regulatory requirements.
- Assist in assessing and reporting adverse events for medical devices and drugs.
- Assist in creating technical dossiers for product registrations in other markets (e.g. EU).
- Assist in Regulatory SOP development and review.
- Assist in SOP development and review. Provide regulatory input to product lifecycle planning.
- Assist in the development of regional regulatory strategy.
- Assist journeyman technicians.
- Assist with all pre-audit preparations.
- Assist with complaints handling and product labelling/claims activities.
- Assist with device recall activities.
- Assist with FDA 510 (k), Japanese and European submissions.
- Assist with FDA facility inspections, Notified Body Audits and other governmental inspections.
- Assist with label development and review for compliance before release.
The MedPharma Contractors Ltd’s life sciences advisory and support practice provides clients with guidance and solutions throughout all stages of the business and product life cycle. From market access strategy to compliance and ethics programs, our team of professionals is here to help.
Contact Us
Contact us today to discover how our specialized contracting services can support your organization. The MedPharma Contractors Ltd is committed to delivering quality solutions that align with your specific needs, driving success in the ever-evolving world of healthcare.