PHARMACEUTICAL & HEALTHCARE SERVICES
An integrated support model across regulatory affairs, quality and compliance, pharmacovigilance, pharmaceutical representation and healthcare solutions, grounded in direct pharmaceutical and regulatory experience.
RGA / REGULATORY AFFAIRS & MEDICINE REGISTRATION
PEKOTA works with pharmaceutical manufacturers, marketing authorisation holders, generic pharmaceutical companies, medical device companies and healthcare suppliers who need a Namibia-based partner to support regulatory and market activities. PEKOTA can act as a local regulatory support partner where appropriately appointed. PEKOTA does not currently represent any pharmaceutical manufacturer, and no appointment, licence or statutory role (including as a local representative, pharmacovigilance officer or QPPV) should be assumed unless explicitly agreed and stated.
RGA-01
Assisting manufacturers with in-country regulatory representation considerations, where appropriately appointed.
RGA-02
Coordinating communication with the relevant Namibian regulatory authorities on a client's behalf.
RGA-03
Supporting dossier preparation, CTD review and registration submission coordination.
RGA-04
Coordinating variation and renewal submissions as products progress through their lifecycle.
RGA-05
Ongoing regulatory lifecycle and deficiency-response support for registered products.
RGA-06
Regulatory coordination for manufacturers preparing to enter the Namibian market.
QC / QUALITY & COMPLIANCE
Practical support for the quality and compliance obligations that come with operating in a regulated market, drawn from direct pharmaceutical quality-systems experience.
QC-01
Support structuring quality systems appropriate to your operation's scope.
QC-02
Drafting, reviewing and organising standard operating procedures and controlled documentation.
QC-03
Structuring corrective and preventive action processes.
QC-04
Guidance on good distribution and manufacturing-adjacent compliance considerations.
QC-05
Preparing documentation and processes ahead of audits or regulatory inspection.
QC-06
Identifying gaps against applicable quality and regulatory requirements.
PVG / PHARMACOVIGILANCE & POST-MARKETING SURVEILLANCE
PEKOTA can provide or support pharmacovigilance and post-marketing activities, subject to relevant appointments and regulatory requirements. PEKOTA does not currently hold a formal pharmacovigilance responsible-person appointment for any client, and no such role should be assumed unless explicitly agreed and stated.
PVG-01
Supporting pharmacovigilance coordination activities in the Namibian market.
PVG-02
Coordinating post-marketing surveillance requirements for registered products.
PVG-03
Coordinating adverse event reporting processes with relevant stakeholders.
PVG-04
Supporting safety documentation and monitoring processes.
PVG-05
Supporting the coordination of product quality complaint handling.
PVG-06
Coordinating recall-related communication and documentation, where required.
REP / PHARMACEUTICAL & MEDICAL REPRESENTATION
A South African, regional or international pharmaceutical manufacturer may not need to establish an entire permanent Namibian commercial team immediately. PEKOTA can support local market presence and representation, delivered in line with applicable pharmaceutical marketing and promotion requirements.
REP-01
Local representation support for manufacturers building a Namibian presence.
REP-02
Professional, compliant engagement with healthcare professionals on product information.
REP-03
Planning coverage across the Namibian market for a given product portfolio.
REP-04
Coordinating local launch activities for newly registered products.
REP-05
Building product and brand awareness within the Namibian healthcare sector.
REP-06
Ongoing local support for manufacturer brands entering or established in Namibia.
HCS / HEALTHCARE & INSTITUTIONAL SOLUTIONS
Beyond regulatory and representation support, PEKOTA sources and coordinates the following categories for healthcare and institutional clients.
Subject to applicable regulatory requirements.
For clinical and institutional use.
For surgical and procedural settings.
General clinical and facility supply.
For workplaces, sites and institutions.
For emergency and urgent-care requirements.
For workplace and site-level health support.
Sourcing coordination for clinical and institutional equipment.
End-to-end sourcing support for healthcare buyers.
SCOPE
All services are offered strictly within the founder's professional competence and PEKOTA's actual current capability. If a request falls outside that scope, or requires a formal appointment or licence PEKOTA does not hold, we will say so directly rather than overreach.