Pharma and Medical Outsourcing

Last updated: November 11, 2026

Pharma and medical outsourcing means that pharmaceutical companies, medical device manufacturers and importers, distributors and pharmacy chains hand over defined, non-decision-making work to an external team: regulatory documentation support, track-and-trace notifications, pharmacovigilance case intake, quality documentation, customer and healthcare professional support lines, warehouse operations, field service for devices, and IT and validation support. In this sector, every activity is subject to documented procedures, and a missing record can mean a failed inspection. Outsourcing must therefore be built on SOPs, training records and clear responsibilities.

360 Soft provides teams from Istanbul that work remotely, at your site or in a hybrid model. This page explains which work can be handed over, how GMP, GDP and MDR requirements shape it, engagement models, SLAs, pricing factors and how to choose a supplier.

Why pharma and medical companies use outsourcing

Regulatory workload: EU MDR and IVDR, product registrations, variations and renewals create documentation peaks that permanent teams cannot absorb.
Serialisation and traceability: national track-and-trace systems (in Turkey İTS for medicines and ÜTS for devices) require timely, accurate notifications.
Specialist scarcity: people who understand both regulatory processes and IT systems are hard to hire.
Launch and tender peaks: new products and public tenders need temporary capacity for documents, data and support.
Cost pressure: reimbursement and price controls push companies to run support functions more efficiently.

Work suitable for outsourcing

Area	Typical tasks	Roles
Regulatory support	Dossier formatting, technical file compilation under your RA lead, labelling and IFU checks, database entries	Regulatory documentation specialist
Track and trace	İTS/ÜTS notifications, master data, error resolution, stock reconciliation	Traceability operator, data specialist
Quality documentation	Document control, training record management, deviation and CAPA administration	QA documentation assistant
Pharmacovigilance intake	Receiving and logging adverse event reports, follow-up requests, translation	PV case intake associate (under your QPPV)
Customer and HCP support	Order and product enquiries, complaint intake, device user support	Support agents, technical support specialists
Warehouse and field	GDP-compliant warehouse support, device installation and preventive maintenance	Warehouse operators, biomedical field technicians
IT and validation	ERP, LIMS, QMS tool support, computerised system validation documentation	System analysts, validation engineers

Systems and technology scope

We work in your validated environment: ERP (SAP, Microsoft Dynamics, Logo), electronic QMS and document management tools, LIMS, pharmacovigilance databases, the Turkish İTS and ÜTS portals, the EU EUDAMED database, CRM and ticketing tools. If you need new software, such as a complaint intake portal or a reporting dashboard, we can develop it under your change control and provide the validation documentation.

Regulatory framework: TİTCK, GMP, GDP and MDR

In Turkey, medicines and devices are supervised by the Turkish Medicines and Medical Devices Agency (TİTCK). GMP and GDP guidelines, aligned with EU rules, require that outsourced activities are covered by a written agreement, that the contract giver remains responsible, and that the contract acceptor is qualified and audited. The EU MDR (2017/745) and IVDR apply to devices placed on the EU market, and the Turkish regulations mirror them. Computerised systems follow GAMP 5 principles and EU GMP Annex 11, and electronic records follow 21 CFR Part 11 where the US market is involved.

In practice this means that we do not act as manufacturer, authorised representative, qualified person or QPPV; we perform tasks under your quality system, your SOPs and your oversight. We train team members on your SOPs, keep training records and support your supplier audit. Local rules in your country also apply.

Engagement models

Model	How it works	Best for
Dedicated team	Named specialists working under your SOPs, managed by our team lead	Track and trace, document control, regulatory support
Managed service with SLA	We own an outcome, such as notification lead time or ticket response	Support lines, PV intake, monitoring
Project-based	Fixed scope, such as an MDR technical file remediation or a validation package	Remediation, launches, migrations
On-site or hybrid	Team members work at your warehouse, plant or customer sites	Warehouse, field service, audits

Process and typical timelines

Discovery (several days): processes, SOPs, systems and volumes are reviewed.
Quality agreement and contract (1–2 weeks): responsibilities are set out in a service agreement and, where needed, a quality agreement.
Recruitment and SOP training (typical start 1–2 weeks): you can interview key roles; training is recorded.
Supervised handover (2–6 weeks): work is reviewed by your staff until agreed quality is reached.
Stable operation: monthly KPI reports, periodic reviews and audit support.

SLA and KPI examples

KPI	What it measures	Example target type
Notification lead time	Time from transaction to İTS/ÜTS notification	Within the legal or agreed time
Case intake time	Adverse event report logged and forwarded	Hours, per your PV SOP
Document accuracy	Documents passing your QA review first time	Percentage agreed in SLA
Training compliance	Team members with current SOP training	Target per quality agreement
First response time	Customer or HCP enquiry answered	Hours, by channel
Device service uptime	Planned maintenance completed on time	Percentage per period

Pricing models and factors

Prices depend on scope, so we quote per project. The usual models are a monthly fee per FTE, a managed-service fee by volume and SLA, or a fixed price for a defined project.

Factor	Effect on cost
Specialisation	Regulatory and validation profiles cost more than data roles
Hours and coverage	7/24 PV intake or support adds shifts
Languages	Multilingual intake or HCP support needs specific profiles
Documentation load	Heavy SOP training and record keeping adds time
On-site requirements	Warehouse or field work adds travel and equipment

In-house staff, freelancers or outsourcing

Criterion	In-house	Freelancer	Outsourcing (360 Soft)
Training records and GxP discipline	Full control	Hard to evidence	Managed and recorded
Speed to start	Slow	Fast	Typically 1–2 weeks
Scaling for peaks	Hard	Limited	From 1 to 200+ people
Continuity	Depends on retention	Low	Backup and replacement process

Pharma and Medical Outsourcing — overview

Risks and safeguards

Responsibility gaps: a RACI matrix in the agreement states who decides and who executes.
Inspection findings: SOP-based work, training records and audit trails.
Patient safety signals missed: clear escalation timelines for adverse events and complaints.
Staff turnover: backup staff trained in advance and a replacement process.
Data protection: health data is special-category data and is handled with strict access rules.

Data security, GDPR, KVKK, NDA and IP

Health data, adverse event reports and patient information are special-category personal data under GDPR and KVKK. We process them only on your instructions, through your systems where possible, with role-based access, logging and confidentiality undertakings from every team member.

Contract and legal note

We work under a B2B service agreement that defines scope, service levels, deliverables and acceptance. It comes with a mutual NDA and a clause that assigns intellectual property in all work products (documents, data sets, code, designs) to you. Where our team processes personal data on your behalf, we sign a GDPR data processing agreement (DPA) with the EU Standard Contractual Clauses, or the UK IDTA/Addendum for UK data; our own processing in Turkey follows KVKK (Law No. 6698). Where GxP work is involved, a separate quality agreement sets out GMP or GDP responsibilities.

360 Soft employs its team members under Turkish labour law and remains responsible for their payroll, social security and supervision. The engagement is a service, not the hiring-out of workers: you define the outcomes and priorities, and we manage the people. Local rules in your country, such as worker classification or agency-work rules, should be checked with your own legal adviser before signing.

Illustrative scenario: MDR and ÜTS workload at a medical device importer

Illustrative scenario. This is not a client case; it shows how such an engagement could be set up. A medical device importer distributes several hundred products from European manufacturers. Each device must be registered in ÜTS, sales and transfers must be notified, and technical documentation must be available for authorities and hospital tenders. The regulatory manager spends most of the week on data entry. A two-person team is set up: one traceability operator handles ÜTS notifications and reconciles stock with the ERP every day, and one documentation specialist builds a structured library of declarations of conformity, certificates and IFUs and tracks expiry dates. Both are trained on the importer’s SOPs, and the regulatory manager reviews their work during the first month, then moves to sample checks.

Supplier selection checklist

Does the supplier accept working under your SOPs and quality agreement?
Can it show training records and support your supplier audit?
Are responsibilities clear, so that regulatory decisions stay with you?
Are escalation times for adverse events and complaints defined?
Is special-category data protected with role-based access and logging?
Are NDA, IP assignment and a GDPR DPA included?
Is there a backup and replacement process?
Can the team scale for launches, tenders and remediation projects?

Frequently asked questions

Which work can pharma and medical companies outsource?

Regulatory documentation support, track and trace notifications, quality documentation, pharmacovigilance case intake, customer and HCP support, warehouse and device field service, and IT and validation support.

Is outsourcing compatible with GMP?

Yes, if the activity is covered by a written agreement, the supplier is qualified and you keep oversight. We work under your quality system.

Do you perform computerised system validation?

We prepare validation documentation and execute tests under your validation plan; approval stays with your quality unit.

Can you take over İTS and ÜTS notifications?

Yes. We handle notifications, master data and error resolution, and reconcile them with your ERP.

Do you prepare MDR technical documentation?

We compile and format technical files under your regulatory lead; we do not act as manufacturer or authorised representative.

How is patient data protected?

Through role-based access, your systems where possible, logging, NDA and a GDPR DPA; health data is treated as special-category data.

Does the support team promote medicines?

No. Our teams answer service enquiries; promotional activity follows your own compliance rules and is not part of our scope by default.

Will the team take our SOP training?

Yes. Training on your SOPs is part of onboarding and is recorded.

How is pricing set?

By FTE per month, by managed-service volume and SLA, or as a fixed project price.

How quickly can we start?

A typical start is within 1–2 weeks, followed by a supervised handover.

Is this a staff leasing arrangement?

No. It is a B2B service; 360 Soft employs and manages the team.

Do you support inspections and audits?

Yes. We provide records and explain our processes to inspectors and auditors.

Contact us

Tell us which pharma or medical processes you want to hand over and under which SOPs, and we will propose a team and a model. Call or WhatsApp us on +90 850 335 10 87, write to info@360-soft.com, message us directly on WhatsApp, or use the form on our contact page. 360 Soft Marketing Yazılım ve Danışmanlık Ltd. Şti., Nidakule Ataşehir Batı, Barbaros Mah. Begonya Sk. No:1 D:2, 34746 Ataşehir/İstanbul.

Türkçe: Türkçe sürüm