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Schedule of services.

Every engagement at PSH is scoped against this schedule, with a written workplan and a named lead before any work starts. Engage one line, or hand us the whole route from dossier to lifecycle.

PART A · RA — REGULATORY AFFAIRS

Registration & lifecycle management

The core of the practice. We prepare, compile, review and submit medicine registration dossiers — and stay accountable through screening, queries and inspection until the authorisation is in your hand.

Scope a registration
Dossier preparation — CTD & eCTDModules 1–5 compiled and gap-checked against current TMDA guidance before anything is filed.
TMDA, TBS & EAC submissionsNational filings plus the EAC harmonised procedure when one dossier should reach several markets.
Variations, renewals & line extensionsLifecycle filings tracked on a calendar we maintain for you — nothing lapses quietly.
Query response managementTechnical queries answered in-house by the team that built the dossier, inside the deadline.
Regulatory strategy & intelligencePathway selection, timelines and fee planning before you commit a shilling.

PART A · PV — PHARMACOVIGILANCE

Safety surveillance that runs as a system

Authorisation is the start of your obligations, not the end. We build and operate pharmacovigilance systems that keep marketing authorisation holders compliant — backed by our own data platform.

Set up your PV system
ADR monitoring & reportingAdverse drug reaction collection, processing and regulatory reporting on the required calendar.
Signal detection & benefit-risk assessmentStructured review of safety data, documented the way an inspector expects to find it.
Risk management plansRMPs written for your product and market, not adapted from a template.
Post-marketing surveillancePMS studies designed and coordinated with local sites and academic partners.
PV system developmentStanding pharmacovigilance capability built inside your organisation, with training included.

PART B · DH — DIGITAL HEALTH

Health software & data systems

Our engineering desk builds the systems the rest of the practice runs on — and builds them for clients too: SaaS platforms, data management and custom software for healthcare operations.

Discuss a build
Health SaaS platformsSubscription software for pharmacies and healthcare institutions, hosted and maintained by PSH.
Healthcare data managementPlatforms for collecting, structuring and reporting clinical and operational data.
Pharmacovigilance information systemsThe data layer under Part A·PV — available standalone for institutions running their own PV.
Custom development & ICT advisoryBespoke systems and digital health strategy, delivered as SaaS, standalone or integrated.

PART C · HC — CONSULTANCY

Quality systems & market entry

For manufacturers, institutions, ministries and investors who need the Tanzanian health market explained, audited or entered — by people who work inside it every day.

Start a conversation
QMS design & implementationQuality management systems built to pass ISO and GMP/GDP certification, not just to exist.
GMP/GDP compliance & inspection readinessGap analysis, remediation and mock inspections before the real one.
Market entry & feasibilityInvestment feasibility studies and entry strategy for Tanzania and the EAC.
Health systems strengtheningProject management and advisory for ministries, regulators, NGOs and development agencies.

PART C · MW — MEDICAL WRITING

Scientific & medical writing

Documents written by people who also file them — so every report is built for the reader who will judge it, whether that's a regulator, a journal or an HTA committee.

Commission a document
Clinical study reportsCSRs structured to ICH expectations, ready for submission.
Regulatory submission documentsExpert reports, overviews and summaries for registration dossiers.
HTA reportsHealth technology assessments for payers, ministries and programmes.
Manuscripts & systematic reviewsPublication-ready scientific writing, from protocol to peer-review response.

PART D · TR — TRAINING & CPD

Training & capacity building

Continuing professional development for the people who keep medicines safe — from one-day workshops to standing institutional programmes, in person or on our digital learning platform.

Request a programme
Accredited CPD programmesFor medical, pharmaceutical and allied health professionals and institutions.
Regulatory affairs workshopsDossier building, lifecycle management and query handling, taught from real cases.
Pharmacovigilance trainingFrom ADR reporting basics to running a full PV system.
Digital health user trainingOnboarding and certification for teams adopting health software.

Not sure which part of the schedule you need?

Tell us where your product or organisation stands. The first consultation costs nothing, and you leave with a written view of the route either way.

Book a consultation

Or write to info@pharmasolutionshub.com — we reply within one business day.