GLOBAL OVERSIGHT

GLOBAL OVERSIGHT SERVICES

Research, Consulting, And Oversight Services

Our mission to provide quality research, consulting, and oversight services. We conduct oversight globally as well as in person inspections, meetings and conference calls to ensure the delivery of therapeutics on behalf of country governments and agencies. We are here to be your trusted partner in the pharmaceutical industry by providing quality representation fir your country or agency.

Please contact us today: 
704-266-3250

I. Quality Assurance and Therapeutic Oversight:

   A. Ensuring patients receive high-quality therapeutic agents:
  1. Rigorous assessment of therapeutic agents' quality and efficacy.
  2. Monitoring adherence to industry standards and regulatory requirements.
  3. Implementing quality control measures throughout the treatment process.

II. Inspection Services:

   A. Conducting ongoing and pop-up inspections to maintain standards:
  1. Regular on-site inspections of manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
  2. Conducting surprise or pop-up inspections to ensure adherence to standards between scheduled inspections.
  3. Identifying areas for improvement and providing recommendations to enhance manufacturing processes.
  4. Conducting in-person inspections for thorough assessment and direct negotiation of services with manufacturers.

III. Representation on behalf of Health Ministries to Pharmaceutical Manufacturers:

   A. Serving as a liaison between governments and pharmaceutical companies:
  1. Advocating for patient needs and interests during drug development, distribution, and pricing negotiations.
  2. Negotiating with pharmaceutical manufacturers on behalf of governments and ministries of health to ensure fair pricing and accessibility of medications.
  3. Facilitating communication and collaboration between patients, healthcare providers, governments, and manufacturers.

IV. Verification and Validation:

   A. Ensuring patients receive quality drugs:
  1. Verifying the authenticity and integrity of pharmaceutical products.
  2. Conducting validation checks to confirm the effectiveness and safety of medications.
  3. Implementing measures to prevent counterfeit or substandard drugs from reaching patients.

V. Continuous Improvement and Monitoring:

   A. Commitment to ongoing enhancement of services:
  1. Regular review and refinement of oversight processes and protocols.
  2. Monitoring industry trends and regulatory changes to adapt practices accordingly.
  3. Soliciting feedback from stakeholders, including governments and ministries of health, to identify areas for improvement and address concerns.

VI. GCP and GMP Services for Foreign Drug Manufacturers:

   A. Ensuring Quality Therapeutics through International Standards:
  1. Offering comprehensive GCP services to foreign drug manufacturers to uphold ethical and quality standards in clinical research.
  2. Providing guidance and support to ensure compliance with GCP regulations set forth by international bodies such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
  3. Conducting audits and assessments of clinical trial processes to verify adherence to GCP guidelines and promote the integrity and reliability of research data.
 
   B. Upholding Manufacturing Excellence with GMP Oversight:
  1. Extending GMP services to foreign drug manufacturers to guarantee the consistent production of high-quality therapeutics.
  2. Collaborating closely with manufacturers to establish and maintain GMP-compliant manufacturing processes, facilities, and quality systems.
  3. Conducting thorough inspections and audits of manufacturing facilities to assess compliance with GMP regulations and identify areas for improvement.
 
   C. Bridging Cultural and Regulatory Gaps:
  1. Providing cultural sensitivity and understanding in navigating regulatory requirements across different regions and countries.
  2. Serving as a trusted intermediary between foreign drug manufacturers and regulatory authorities to facilitate communication and streamline compliance efforts.
  3. Offering tailored training programs and resources to foreign manufacturers to enhance understanding and implementation of GCP and GMP standards.
 
   D. Fostering Collaboration for Global Healthcare Advancement:
  1. Promoting collaboration and knowledge exchange between foreign drug manufacturers, regulatory agencies, and healthcare stakeholders to advance global healthcare standards.
  2. Facilitating partnerships and alliances to foster innovation, enhance drug development processes, and improve patient outcomes worldwide.
  3. Advocating for the harmonization of international regulatory standards to ensure consistency and efficiency in the evaluation and approval of therapeutics across borders.
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