PharmPlay Group

We tailor-make services to meet the unique needs of our clients.

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1. GMP Inspections and audits

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We inspect and audit  pharmaceutical manufacturing facilities to check for compliance with current Good Manufacturing Practices (cGMP). Our scope covers sterile and non-sterile facilities producing  human and/or veterinary range including oral dosage forms, small and large volume parenterals, inhalations, granules, patches, medical devices such as condoms  and foods by prescription (FBPs) with a geographical reach spanning Africa, Asia, Europe , USA , The Caribbean and South America.

We also carry out inspections to check compliance with Good Distribution Practices (GDP) for pharmaceutical wholesalers, distributors and warehouses.

Our WHO and ICH trained Inspectors carry out this work.

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2. Technical assessment of pharmaceutical dossiers

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We carry out technical evaluations of pharmaceutical product dossiers for the quality part of each dossier and bio-equivalence as well as all areas constituting a dossier prepared according to the Common Technical Documents (CTD) format. We also cover dossiers prepared for in-house pre-qualification programs such as the inter-agency questionnaire for finished pharmaceutical products utilized by large scale procurers like UN agencies, The Global Fund and Doctors without Borders (MSF).

Our WHO trained Technical Assessors carry out this work.

 

3. Procurement and Supply Management (PSM)

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We help with assessing and  building capacities of supply chains of various complexities. This can be a supply chain within an organization integrating e-commerce solutions or within a county or within a state or a huge organization handling several products across different countries.

Our PSM experts experienced in public and private sectors carry out this work.

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4. Capacity Building and Advisory Services

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We help with diagnosis of bottlenecks and areas of improvement to manage projects and programs in the themes or disease areas of Nutrition, Immunization, HIV/AIDS, Zika, Tuberculosis, Hepatitis, Antimicrobial Stewardship, Sexual Health, Malaria, Population and Reproductive Health (PRH), Diabetes, Maternal Newborn and Child Health (MNCH), Cancer, Smoking Cessation, Adolescent Health and Aging. 

Our subject matter experts carry out this work depending on scope required to ensure appropriate capacity building.

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5. Economic Evaluation

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We help with economic evaluation of public health and social programs for systemic identification , measurement and  comparative analysis of  inputs and outputs. We have depth in Health Economics covering such areas as cost -benefit analysis, cost-effectiveness analysis, cost-utility analysis, cost-consequences analysis and Disability Adjusted Life Years (DALYs). We also cover epidemiology and pharmacoepidemiology  analysis including building models for decision making by organizations of various sizes. We utilize quantitative and qualitative research methods for systematic review, clinical trials research and a variety of situations requiring use of decision sciences.

This work is carried out by our associates who are PhD holders in the areas of Health Economics, Medical Economics,  Pharmacoeconomics, Clinical Epidemiology, Pharmacoepidemiology, Health Policy, Health Services Research and Social Policy.

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