What we do

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Our Expertise

Despite the dynamic pharmaceutical industry and the growing number of multinational pharmaceutical generic manufactures, there remains in many therapeutic areas a lack of quality-assured, affordable products. As part of our mission to increase access to quality-assured affordable reproductive and maternal health products in Low- and Middle-Income Countries (LMICs), Concept Foundation is providing services along the product life cycle. We provide technical support to help manufactures expand their portfolio where there is an acute unmet need pertaining to reproductive and maternal health products and also provides technical and regulatory support to manufacturers towards the WHO prequalification (PQ). Our activities, focussed on reproductive and maternal health medicines, support the introduction of health technologies in low- and middle-income countries from product development to availability:

Product Development

Technical Support for Generic Manufacturers

Technology Transfer

R&MH product development/research

Manufacturing Quality

GMP Documentation (FPP + API) and technical assistance

Bioequivalence (FPP)

Assessment of manufacturing quality standards

Regulatory Approval

WHO Prequalification Assistance for Generic Manufacturers

EMA Article 58, SwissMedic MAGHP assistance

Regulatory dossier preparation and submissions

Registration

LMIC product registration

Quality Assurance

Technical Support for Generic Manufacturers

GMP Assistance

GMP Documentation (FPP + API)

WHO Prequalification Assistance for Generic Manufacturers

Medicines Quality testing/surveys

Product Introduction

Generics market research

Messaging and communications

Market Access assistance

Stakeholder mapping

Procurement & Supply

Identification of Agents

RFP preparation

Advocacy & Communications

R&MH consultations/workshops

Market Shaping

Investment/Business case

Cost effectiveness

Budget impact

R&MH generic product marketing

Policy

EML and Guideline submissions

Policy briefs, Issues Briefs

Policy advocacy

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