QUICK LINKS -

This is paragraph text. Click it or hit the Manage Text button to change the font, color, size, format, and more. To set up site-wide paragraph and title styles, go to Site Theme.

MERILANE offers wide-ranging life-science solutions that accelerate clinical research, help pharmaceutical, biotech and medical device companies shorten time-to-market, maintain product licences, and best support patients.


Our smart solutions can be tailored to support local clinical trials, large global clinical programs as well as marketing authorisation applications and post-marketing activities.


Browse our solutions below and contact us today for support.


Regulatory Affairs


With extensive experience of global Regulatory Authorities including the EMA, the MHRA and the US FDA, we are well-positioned to deliver industry-leading strategic and operational support to expedite drug and device development programs across the entire product lifecycle.


No project is too big or too small. From comprehensive outsourcing of your entire Regulatory Affairs function to targeted support for a single submission or standalone project, Merilane offers flexible, expert Regulatory Affairs solutions tailored to your needs.


Key Areas of Regulatory Expertise Include:


Functional Service Delivery Option Available For Any of the Following Solutions

This is paragraph text. Click it or hit the Manage Text button to change the font, color, size, format, and more. To set up site-wide paragraph and title styles, go to Site Theme.

This is paragraph text. Click it or hit the Manage Text button to change the font, color, size, format, and more. To set up site-wide paragraph and title styles, go to Site Theme.

Leadership & Management

  • Regulatory Strategy
  • Governance & Oversight
  • Staff Utilisation Optimisation
  • Key Performance Indicators & Metrics
  • Regulatory Project Delivery including cross-functional initiatives, Acquisition, Divestment, Global Expansion
  • Program Management
  • Risk Identification & Mitigation
  • SOP Development / Streamline
  • Escalation Point
  • Regulatory Training
  • Regulatory Department establishment, management, optimisation


Clinical Trials

  • Regulatory Submission Strategy
  • Document Preparation & Review
  • Labelling Development, Country Adaptation, Management 
  • Redaction of trial materials
  • Clinical Trial Authorisation (CTA) preparation, submission, approval, life cycle management
  • Regulatory & Ethics Submissions
  • CTIS Compliance Verification
  • Agency Meetings, Interactions
  • Regulatory Intelligence
  • Strategic & Ad Hoc Consulting
  • Regulatory briefings, Operational Comms



Marketing Authorisations

  • Strategic Advice
  • Expedited Pathways, e.g. Accelerated Assessment, Priority, Prime Schemes
  • MA Due Diligence & Gap Analysis
  • Scientific Advice
  • Briefing Document preparation
  • Orphan Drug Applications
  • Paediatric Investigational Plans
  • Risk Management & Mitigation Strategies
  • Licence Maintenance & renewal
  • Readability & User Testing
  • Regulatory Authority Meetings
  • Regulatory Information Management
  • Promotional material review & management


Legal Representation

EU Legal Representation is a mandatory legal and regulatory requirement for companies based outside the European Union. Legal Representation is essential for key activities such as the conduct of clinical trials involving medicinal products or medical devices, as well as marketing authorisation applications and placing medicines/devices on the EU market. Merilane specialises in a range of EU Legal Representation solutions offering integrated regulatory oversight and project management to ensure seamless execution and compliance whilst maximising value for you.

Clinical Trials

Article 74 of the EU Clinical Trial Regulation 536/2014   ('EU CTR') requires Clinical Trial Sponsors that are established outside the EU to appoint an EU Legal Representative. In some cases, a contact person may be sufficient. 


Merilane's seamless EU Clinical Trial Legal Representation solution ensures full compliance with Sponsors obligations per the EU CTR.

Marketing Authorisation Applicant / Holder

Directive 2001/83/EC & Regulation 726/2004 require the Marketing Authorisation Applicant & Holder be established in the EU.


Merilane offers full-service EU Marketing Authorisation Applicant & Holder (MAH) capabilities. Acting as your EU-based MAH, we ensure regulatory compliance, product oversight, and seamless interaction with EU regulatory authorities across the product lifecycle.

Orphan Drugs

Under Regulation 141/2000   sponsors applying for or holding an orphan medicinal product designation (ODD) must be based in the EU. A local representative, known as the Orphan Drug Designation (ODD) holder, may be appointed to fulfil this requirement.


Merilane  supports the development of medicines for rare diseases by acting as ODD holder, securing regulatory incentives and ensuring compliance with annual reporting requirements.

EU QP for Pharmacovigilance (QPPV)

Directive 2001/83/EC & Regulation 726/2004 mandate that marketing authorization holders must have a QPPV permanently and continuously available.


Merilane's QPPV solution assists clients in developing and maintaining a robust Pharmacovigilance system through 24/7 availability, adherence to Good Pharmacovigilance Practices (GVP), and strategic guidance for regulatory submissions.

General Data Protection Regulation (GDPR)

Article 27 of the GDPR requires companies located outside the EU to appoint an EU representative if they process personal data in the offering of goods or services, or monitoring the behaviour of individuals in the EU.


Merilane's GDPR EU Representation service fulfils the requirements set out by the GPDR, and supports clients in navigating the complex legislative environment surrounding this data privacy framework. 

Learn more

CTIS Compliance

The Clinical Trials Information System (CTIS), managed by the European Medicines Agency (EMA), streamlines clinical trial applications (CTAs) and ensures compliance across the EU and European Economic Area (EEA).   CTIS plays a key role in maintaining transparency and regulatory oversight while facilitating interactions between sponsors and authorities throughout the trial process. CTIS compliance is essential to avoid delays, rejections, regulatory penalties, loss of public trust due to failure to adhere to transparency requirements, legal risks or operational challenges. Merilane's CTIS Compliance Solution ensures your clinical trials remain compliant, on time, and protected throughout the CTIS lifecycle.

CTIS Submission Management & Strategy

End-to-end management of CTAs through CTIS, including initial submissions, responses to RFIs, substantial modifications, and notifications.

CTIS Compliance Monitoring & Reporting

Ongoing monitoring of CTIS entries to ensure regulatory timelines are met (e.g., posting trial results, updates on trial status, and public disclosures).

Public Disclosure & Transparency Oversight

Review & redact trial documentation to protect personal data and commercially confidential information (CCI) prior to public posting.

Stakeholder Training & System Navigation Support

Training and hands-on support for internal teams or sponsors on CTIS use, document requirements, and regulatory expectations.

Vendor Management

Merilane's GxP Vendor Management solution delivers full-lifecycle oversight, from selection to decommissioning. You can be as 'hands-on' as you wish - knowing Merilane is taking care of the day-to-day tasks. We define requirements, qualify vendors through audits and risk assessments, and manage onboarding with clear contracts and quality agreements. Through ongoing performance monitoring and issue resolution, we ensure compliance and accountability. We also support requalification, renewals, and offboarding, helping you maintain a compliant, efficient, risk-controlled supplier network.

Our approach follows the following steps -

This is paragraph text. Click it or hit the Manage Text button to change the font, color, size, format, and more. To set up site-wide paragraph and title styles, go to Site Theme.

    1. Pre-Qualification & Selection


  • Define Requirements
  • Due Diligence, Risk Assessments
  • Assess Capabilities (pre-audit)
  • Selection based on established criteria


    3. Pre-Qualification & Selection


  • Monitor KQIs, deliverables, performance
  • Periodic audits, performance reviews
  • Track and manage Quality Events
  • Maintain updated Risk Assessments

  2. Qualification & Onboarding


  • Qualification Audits (remote/on-site)
  • Finalise QTA Agreements, Contracts
  • Approve vendors in internal systems
  • Vendor Training (SOPs, KQIs etc.)


   4. Re-evaluation & Decommissioning


  • Periodic performance reassessment
  • Contract renewals or terminations
  • Exit audits as appropriate
  • Archiving per retention policies

Quality Management


Before initiating any regulatory process, it is crucial to ensure that your internal systems, and those of your suppliers, comply with required standards. Adhering to Good Practice (GxP) is vital to consistently ensure product quality, safety and efficacy, and to demonstrate to regulators that all elements align with their expectations.


Merilane's expertise spans all GxP areas, along with related regulatory competencies, enabling us effectively manage your complex quality challenges while delivering added value, particularly for small and medium-sized enterprises.  Our proactive, risk-based approach, helps clients build a strong quality culture that supports operational excellence, product quality and inspection readiness.

This is paragraph text. Click it or hit the Manage Text button to change the font, color, size, format, and more. To set up site-wide paragraph and title styles, go to Site Theme.

Our end-to-end Quality solutions ensure compliance, consistency, and continuous improvement across the full GxP spectrum. We also support all operational QA / QM tasks from small standalone projects to complete outsourcing of Quality functions. Our experts are here to help - no matter your need. Additional services include SOP development and optimisation, quality risk management, deviation and CAPA support, and more -

  • QMS Assessment, Design & Execution
  • Quality Plan Development
  • Quality KPI Development & Monitoring
  • SOP Writing, Streamlining & Improvement
  • Complaint Handling & Investigations
  • Deviation Management


  • CAPA Management, Effectiveness checks
  • Recalls / Mock Recalls
  • Product Quality Review approval, and process management
  • Generation of Quality / Technical Agreements
  • Quality Documentation, generation, management & archiving
  • Computer System Design & Validation


Audit and Compliance

Merilane's Audit and Compliance Services group provides GxP governance and compliance oversight to our clients. To maximise benefit to clients we have identified key elements necessary for a successful audit program, and developed audit assessment tools for the assessment of GxP processes, organisations, and products and service quality. These have been integrated into Merilane's Audit Manual which sets out the preparation, execution and reporting of all types of GxP audits in a standardised manner, including audit agenda templates and assessment tools supporting consistency and efficiency. Our audit manual provides related guidance and regulatory reference documents and provision for requirements as set out in Client SOPs. Its scope encompasses the full range of GxP audits, including GCP audits (Pharmacovigilance and Clinical Investigator site monitoring), Good Laboratory Practices audits, and Computer System Validation. For GMP audits, our manual defines routine audit types such as surveillance audits for manufacturing sites, as well as audits conducted less frequently, such as baseline GMP assessments or mock Pre-approval Inspections (PAI).


We recommend audit targets are selected using a risk based approach factoring in the following:

  • Audit type or process complexity
  • Business Impact or Criticality of System
  • Regulatory History with Regulatory Authorities
  • Quality & Compliance History (internal)
  • Site self-assessments including any risk analysis performed
  • Market (local / global impact)
  • Health Authority (National vs. International)

GMP Audits

Audit ensures that medicinal products are consistently produced and controlled to quality standards appropriate for their intended use. 


Audits focus on manufacturing processes, facilities, documentation, and quality systems, and cover facilities such as Manufacturing and repackaging sites, warehouse and distribution and non-manufacturing sites. 

GLP Audit

Audit of your internal or your third party laboratory (analytical, microbiology, toxicology)


Audit covers EU, US, Row Regulations as appropriate. 


Audit covers Sampling handling, Laboratory data control and review practices, Raw data review and traceability, Method type and validation practices, Instrumentation calibration , Lab design, Training and more.

CSV Audit

This audit will challenge and review your computer system steps and deliverables, as well as system specifications, testing documentation, and system operating procedures including compliance to 21 CFR Part 11 and other relevant requirements.


Detailed review includes:

  • Validation Protocol / Quality Plan, and report
  • High Level Risk Assessment
  • User Requirements Specification (URS)
  • Funcational Specification (FS)
  • Functional Risk Assessment (FRA)
  • Design Specification (DS

GCP Audit

GCP Investigator site audit to assess the study conduct by the site including personnel, inclusion/exclusion criteria, Informed Consent Form (ICF), Drug accountability, CRF, Documentation, Trial Master File, IRB involvement and more.

Merilane audits include:


Preparation Phase

  • Auditee role selection
  • Process review
  • Data review
  • Inspection history review
  • Audit agenda drafted


Audit Conduct & Communication

  • Opening meeting (audit agenda reviewed & adjusted if required)
  • Audit interviews (Observations are communicated verbally to auditees present)
  • Evidence collection and review
  • Critical issues are brought to the attention of management immediately
  • Daily wrap-up meetings (c. 15 minute duration) at the beginning/end of each day
  • Close out meeting (observations summarised)


Audit Report

  • Draft audit report including all observations and Executive Summary provided within 5 working days of audit completion
  • Final audit report  issued within 10 working days of audit completion (unless otherwise agreed)


Medical Writing

 

  • Clinical Regulatory Documentation
  • Post-Marketing Regulatory Dossier
  • Dossier Review & QC
  • Work in Clients Documentation System
  • Promotional Material
  • Clinical & Medical Translations
  • Linguistic Translations
  • Product Labelling
  • Patient Narratives
  • Lean Writing Processes

Scientific Communications


  • Cross-functional Publications
  • Posters, Articles, Blogs
  • Messaging calendars
  • Scientific writing & editing
  • Corporate Communications & Strategy
  • Communication & Messaging Plans
  • Publication Plans
  • SOP writing & Simplification
  • Funding / Grant Applications
  • Regulatory, Scientific Newsletters


Project Management


  • Clinical Trial Project & Program Level
  • Bespoke Cross-Functional Projects
  • Effective Resource Management
  • Project Roadmap Creation
  • Risk Assessment & Mitigation
  • Delivery Structures & Processes
  • Stakeholder Analysis & Engagement
  • Oversight Committee Set-Up
  • Transparency & Regular Reporting
  • Lessons Learned & Best Practices

Patient First Approach

Patient-centricity is at the heart of all our solutions. Together we can ensure patients gain access to your product sooner.

Your Trusted Partner 

Inspection-ready and committed to operational excellence - with Merilane as your trusted partner, this will be your advantage.

Smart Flex Resourcing

Whether you need long-term support or temporary short-term cover, Merilane takes pride in offering flexible, cost-effective solutions that support your need.

Agile, Creative Mindset

Streamline your processes with Merilane's proven solutions. Connect with us today so we can help you realise your product's value.

Contact Us