Regulatory & market entry
A practical route for your product, portfolio and target countries.
- Product classification and pathway assessment
- Country-specific requirements mapping
- Gap analysis and submission planning
UAE based. International perspective.
A clearer path to
pharma markets.
10+Over 10 years in business.Established March 2016
Regulatory strategy, GMP support and MOH tender consultancy for pharmaceutical businesses entering the EU, Ukraine and GCC.
NEW MIND SOLUTIONS FZE · Hamriyah Free Zone, Sharjah, UAE
CONNECTED BY A CLEAR STRATEGY
Three regions.
Market-specific expertise.
01
European UnionRoute selection & dossier readiness
↗02
UkraineRegistration & regulatory coordination
↗03
GCCCountry-by-country market planning
↗REGULATORY AFFAIRS / GMP & GDP READINESS / PRODUCT LIFECYCLE SUPPORT
Our expertise
From regulatory complexity
to a practical next step.
We help manufacturers and pharmaceutical businesses organise the evidence, documentation and actions needed for their target markets. Each engagement starts with a defined scope and clear responsibilities.
Dossier & submission support
Structured preparation for applications and regulatory correspondence.
- CTD dossier review and document coordination
- Regional administrative requirements
- Submission and authority-query coordination
GMP & GDP readiness
Prepare quality systems and documentation for regulatory scrutiny.
- Compliance gap assessments
- SOP and quality-document review
- Inspection preparation and CAPA planning
Post-registration support
Keep regulatory documentation aligned as your product evolves.
- Variation and renewal coordination
- Labelling and product-information review
- Regulatory change assessment
Clinical regulatory support
Documentation and coordination for clinical development activities.
- Clinical submission document coordination
- Regulatory and ethics-query support
- Liaison with the sponsor and appointed CRO
Pharma business advisory
Connect your regulatory plan with day-to-day execution.
- Partner and service-provider coordination
- Document workflows and project tracking
- Portfolio prioritisation and launch planning
Regional focus
One strategy never
fits every market.
Regulatory pathways depend on the product, application type and destination. We help turn those differences into a coordinated plan.
01 / EUROPEAN UNIONThe right route.
The right route.
A stronger dossier.
EU authorisation can follow centralised, decentralised, mutual-recognition or national procedures, depending on eligibility and product status.
Regulatory reference: European Medicines Agency ↗
- Assessment of the applicable authorisation pathway
- CTD and regional documentation gap review
- Product-information and labelling coordination
- GMP, GDP and lifecycle requirements planning
- Coordination with appropriately qualified EU providers where required
02 / UKRAINELocal requirements.
Local requirements.
Coordinated execution.
Ukraine has its own medicinal-product registration framework. Planning must account for the applicable national procedure, expert evaluation and current regulatory requirements.
Regulatory reference: State Expert Center of the Ministry of Health ↗
- Registration, re-registration and variation planning
- Dossier and Ukrainian product-information coordination
- Support for submissions and responses to official inquiries
- GMP documentation and inspection-readiness coordination
- Local regulatory and service-provider liaison within the agreed scope
03 / GULF COOPERATION COUNCILRegional ambition.
Regional ambition.
Country-specific planning.
The GCC has a central registration system alongside national regulatory requirements. The applicable route, local representation, pricing and import requirements must be assessed for each destination.
Regulatory references: GCC Health Council ↗ · UAE EDE ↗ · Saudi SFDA ↗
- Target-country and registration-route assessment
- Dossier, company and manufacturing-site document coordination
- Country-specific labelling and administrative planning
- Local agent and licensed service-provider coordination
- Lifecycle and authority-query support
A clear role. Clear accountability.
NMS acts as a consultancy and, where permitted and duly authorised, a submission and correspondence agent. We do not act as the marketing authorisation holder. Decisions and certificates remain with the competent authorities; approval outcomes and timelines cannot be guaranteed.
GMP compliance & remediation
Resolve the gaps.
Prepare for inspection.
A certificate alone does not resolve operational weaknesses. We help manufacturers assess GMP issues, organise remediation and prepare evidence of sustainable improvement.
GMP gap assessment
Review the quality system, facility documentation and existing inspection observations against applicable GMP expectations.
- Site Master File and SOP review
- Personnel, premises and material flows
- Supplier qualification and outsourced activities
Deviations & CAPA
Structure a response to recurring issues and inspection deficiencies, with accountable actions and measurable follow-up.
- Root-cause analysis and risk assessment
- CAPA plans and response documentation
- Effectiveness checks and evidence tracking
Validation & data integrity
Review the documentation that demonstrates your processes, systems and results remain under control.
- Qualification and validation planning
- Cleaning, process and computerised-system documentation
- Data integrity, QC records and change control
UKRAINE · PIC/S GMP
Ukraine GMP approval support
Consultancy for manufacturers seeking GMP certification or confirmation in Ukraine, with preparation aligned to applicable Ukrainian requirements and PIC/S GMP standards.
Discuss Ukraine GMP approval support ↗- Application-route assessment and manufacturing-site document review
- Site Master File, GMP evidence and submission-document coordination
- Inspection preparation, CAPA planning and responses to official inquiries
Ukraine’s medicines authority is a PIC/S Participating Authority. NMS supports the application process; certificates and conclusions are issued by the competent Ukrainian authority. Acceptance in other countries depends on their own requirements.
Official references: Ukraine GMP procedures ↗ · PIC/S participating authorities ↗
Prepare the team
Mock-inspection planning, document readiness, staff preparation and post-inspection response coordination.
GMP status review
Assess available inspection evidence and applicable EU GMP requirements, including third-country manufacturing-site considerations.
Confirmation support
Coordinate documentation for the applicable national GMP confirmation or recognition procedure and official queries.
Market-specific evidence
Map manufacturing-site and GMP documentation requirements to the selected regional or national pathway.
PIC/S is a cooperation scheme between regulatory authorities; it does not issue GMP certificates. Certification and recognition depend on the competent authority, site, activities and applicable procedure. NMS provides consultancy and coordination support.
Official references: EU GMP guidance ↗ · Ukraine GMP procedures ↗ · PIC/S FAQ ↗
Discuss a GMP issue ↗MOH & public procurement
A considered bid.
A complete submission.
Consultancy for pharmaceutical tenders issued by Ministries of Health, public procurement bodies and government healthcare institutions in your target markets.
Tender assessment
Review tender scope, product specifications, eligibility criteria, registration status and submission deadlines to support a bid/no-bid decision.
Technical & administrative files
Coordinate product dossiers, GMP evidence, manufacturer authorisations, declarations and other documents required by the specific tender.
Pricing & bid coordination
Support pricing analysis, commercial-document preparation and review of delivery schedules, shelf-life requirements and contractual obligations.
Support through the tender process.
Discuss a tender ↗We help coordinate pre-bid questions, submission checklists, clarification responses and post-award documentation within the agreed scope. Bidder eligibility, local representation, bid securities and submission authority are assessed for each tender. The authorised bidder submits and contracts with the procuring entity; consultancy does not guarantee an award.
Pharmaceutical marketing compliance
Communicate responsibly.
Promote with confidence.
Consultancy on pharmaceutical marketing rules, regulatory requirements and promotional practices for the EU, Ukraine and GCC. We help teams assess campaigns before launch and develop practical internal controls.
Promotional materials & claims
Review product claims, supporting references and consistency with approved product information.
- Brochures, presentations and medical-representative materials
- Scientific substantiation and fair presentation
- Promotional and non-promotional content assessment
Advertising & digital channels
Assess planned audiences, websites, social media and campaigns against the requirements of the target market.
- Prescription and non-prescription product considerations
- Public-facing and professional-facing communications
- Advertising approval requirements and submission coordination
HCP engagement & governance
Review policies for healthcare-professional engagement, events, sponsorships and promotional activities.
- Internal approval workflows and responsibilities
- Training, samples, hospitality and transfers-of-value considerations
- Compliance checklists and escalation procedures
Market-specific review, before publication.
Discuss marketing compliance ↗The review scope is tailored to the product category, registration status, audience, channel and destination country. We can coordinate with local legal or specialist advisers where needed. NMS provides consultancy; final publication decisions and required official approvals remain with the responsible company and competent authorities.
Business management & IT consultancy
Stronger operations.
Smarter systems.
Practical advisory for business planning, operational improvement and digital transformation, with a particular focus on pharmaceutical organisations.
Business management
Align business goals, processes and responsibilities with a practical operating plan.
- Business strategy and growth planning
- Process review and operational improvement
- Management reporting, KPIs and project governance
- Partner coordination and commercial planning
IT consultancy
Build an IT roadmap that supports your teams, workflows and business priorities.
- IT strategy and software requirements assessment
- ERP, CRM and document-management system selection support
- Workflow automation and digital document processes
- Data governance, access controls and integration planning
From assessment to an agreed plan.
Discuss business or IT consultancy ↗We help define priorities, requirements and implementation roadmaps, and coordinate with your appointed service providers. Software development, system implementation, cybersecurity testing and regulated-system validation are included only when expressly agreed in the project scope.
How we work
Clarity at every stage.
Know what is needed, who is responsible and what comes next. Our approach keeps the project focused on documented requirements and agreed deliverables.
Understand
Define your products, target markets, existing approvals and business objectives.
Assess
Review available documentation, identify gaps and map the applicable route.
Coordinate
Agree the scope, prepare documents and coordinate submissions and inquiries.
Maintain
Support agreed follow-up activities, variations and regulatory updates.
Useful to know
Before we begin.
What should I share for an initial assessment?
Send the product name or INN, dosage form, strength, manufacturing country, target markets, current approvals and a brief summary of available dossier and GMP documentation. Please avoid sending patient information.
Can one approval cover all three regions?
The EU, Ukraine and GCC have distinct regulatory frameworks. Existing approvals may be relevant to some pathways, but they do not automatically authorise supply in every target country.
Does NMS issue GMP certificates or regulatory approvals?
No. NMS supports preparation, documentation and coordination. Only the relevant competent authorities issue regulatory approvals and official certificates.
How are fees and timelines agreed?
After reviewing the product and target markets, we define a project-specific proposal. Consultancy fees, authority fees, translations, testing and third-party costs are identified in the agreed scope. Regulatory timelines depend on the procedure and authority assessment.
Start a conversation
Your next market
starts with a clear plan.
Tell us about your product and where you want to go. We’ll help define the next step.
Discuss your project ↗nms@nmsfze.ae ↗NEW MIND SOLUTIONS FZE
ELOB Office No. E-18F-37
Hamriyah Free Zone, Sharjah
PO Box 53979, United Arab Emirates+971 55 417 4513
ELOB Office No. E-18F-37
Hamriyah Free Zone, Sharjah
PO Box 53979, United Arab Emirates+971 55 417 4513
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