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REGULATORY AND QUALITY ASSURANCE

Encha Health has highly skilled regulatory affairs and quality assurance capabilities.

Our technical objectives within Encha Health is to ensure compliance with the highest local and international standards.

In South Africa, SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products. This includes clinical trials, complementary medicines, medical devices and in-vitro diagnostics (IVDs). Furthermore, SAHPRA has the added responsibility of overseeing radiation control in South Africa.

SAHPRA’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973). SAHPRA has three pillars to ensure that medicines, medical devices and IVDs meet the requisite standards to protect the health and well-being of South Africans:

  • Safety
  • Efficacy
  • Quality

It is these three pillars that define the ethos of SAHPRA. (For more information please visit www.sahpra.org.za)

Regulatory Affairs

Our experienced technical and regulatory teams take care of all forms of dossier preparations and submissions, as well as offering our business partners, customers and patients complete peace of mind across the product value chain from IP protection to life-cycle management and pharmacovigilance solutions.

Capabilities include activities such as:

  • Global regulatory competence with TGA, MHRA, EMA, and PIC/s countries HA
  • Pre-submission activities including dossier due diligence and regulatory submission strategy
  • Dossier compilations including cross-market gap analysis management and full dossier conversions to CTD / eCTD format
  • Marketing authorization applications and proven ability to navigate highly complex regulatory environments
  • Core competence in utilisation of EXTEDO software applications
  • NCE experience
  • Medical device expertise
  • Post-marketing authorisation activities including maintenance, variations, renewals, notifications, public notifications as well pricing and reimbursement
  • Tender market applications and expedited approval pathways
  • Named-patient applications

Quality assurance & pharmacovigilance

At Encha Health, we place an emphasis on providing comprehensive customer support, at all phases of the product life cycle. Our highly experienced technical team ensures compliance across all areas of quality assurance and pharmacovigilance through a close collaborative approach with our partners, key stakeholders, and regulatory authorities. We are committed to continuous process improvements to enable an ongoing ability to meet the increasingly complex regulatory requirements.

Our collaborative approach in optimising available resources enables effective management of end-to-end quality and pharmacovigilance activities, such as:

  • Responsible pharmacist and qualified person responsible for quality assurance and pharmacovigilance purposes.
  • Adverse events, periodic safety update reports, expert reports, internal audits, third party GMP audits and training oversight are all covered within our technical departments.