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Welcome To

Pharma Consultants

Kikay Pharma Consultants

 
 

OUR VISION

Our vision is to become the trusted partner of choice for regulatory affairs teams across South Africa and Africa. We strive to provide expert assistance in navigating the complex regulatory landscape, ensuring that our clients achieve and maintain the highest standards of compliance and quality. By offering tailored, innovative solutions and leveraging our extensive industry experience, we aim to streamline regulatory processes, reduce time-to-market, and enhance the overall efficiency and effectiveness of our clients’ operations thereby ensuring that consumers have faster access to safe, high quality and effective products. We are committed to fostering long-term relationships built on trust, collaboration, and a shared commitment to excellence in regulatory affairs.

Pharma Consultants - Safety
Pharma Consultants - Quality
Pharma Consultants - Efficacy

OUR SERVICES

  • New Product Applications in South Africa & Africa for Medicines, Complementary Medicines & Cosmetics
  • Life-cycle management activities in South Africa & Africa including regulatory assessments
  • Responses to recommendations and deficiencies
  • Renewal applications in South Africa & Africa
  • Gap Analysis/Due diligence for new dossier applications & other applications
  • Submission of promotional material applications to Health Authorities in Africa
  • Compilation of Baseline dossiers for SAHPRA in eCTD
  • Development of Regulatory strategies
  • Licencing applications
  • Project management
  • Promotional Material Compliance
  • Artwork Compliance
  • Regulatory Dossier Management
  • Development of SOPs, work instructions & templates for various regulatory activities & new regulatory intelligence

*If a service you are looking for is not mentioned above, please contact us for more information.

Pharma Consultants - Regulation
Pharma Consultants - Compliance
Pharma Consultants - Regulation & Compliance