We provide comprehensive support in pharmaceutical quality systems, GMP compliance, and operational excellence. Our services are tailored to manufacturers, MAHs, CMOs, and distributors seeking regulatory-ready systems and continuous improvement.

We specialize in mock inspections, company gap analyses, and comprehensive GMP/GDP/GLP audit preparation. Our services are tailored to the regulatory requirements of EU authorities and global markets, supporting clients from the earliest setup stages through final inspections. We also assist with supplier qualification to ensure the entire supply chain meets compliance expectations. We are proud to maintain a 100% success rate for clients audited and certified by EU authorities following our preparation program.

We help design, implement, and optimize pharmaceutical quality systems in full alignment with EU GMP, ICH Q10, and client-specific operations. Our team provides support for SOP writing and review, document management, deviation and CAPA systems, and controlled documentation workflows. We ensure your QMS is not just compliant—but practical, scalable, and inspection-ready.

We deliver focused training sessions for staff at all levels—customized for your product types, operations, and regulatory challenges. Whether it’s GMP fundamentals for new hires or advanced inspection-readiness sessions for QA teams, our training helps build internal capability and confidence. Sessions are available online or on-site and can be combined with mock audit feedback for optimal learning impact.

We offer Qualified Person (QP) services for the certification and release of pharmaceutical batches intended for the EU market. Our QPs can support both routine batch release and the issuance of QP Declarations for clinical trial applications and EU import purposes. Services cover the full spectrum of pharmaceutical products, including sterile and non-sterile forms, investigational and commercial batches.

We provide toxicological justification and documentation for GMP-compliant cleaning validation programs:

• Selection of worst-case products
• PDE-based carryover limits
• Residue and impurity assessments
• Final reporting for regulatory and QA/QP acceptance

We provide practical, hands-on support across the full lifecycle of pharmaceutical production—from early R&D to commercial manufacturing. Whether you’re developing a sterile injectable, transferring production to a new site, or scaling up operations, our team ensures technical robustness, regulatory compliance, and smooth execution.

We offer expert consulting and technical input for the development of sterile finished dosage forms, including small molecule injectables and complex formulations. Our services cover formulation strategy, aseptic process design, and compatibility studies to help you reach clinical and commercial readiness efficiently.

We support you in identifying, qualifying, and securing reliable suppliers of APIs, excipients, and critical materials. Our team helps establish an end-to-end pharmaceutical supply chain tailored to your product needs, production scale, and market requirements.

From laboratory-scale batches to full-scale commercial production, we manage analytical and technology transfers across global partners. We prepare or review transfer protocols, coordinate execution, and ensure documentation meets GMP and regulatory expectations on both sides.

We provide access to our partner Helgeheim facility in Martin, Slovakia—an EU GMP-compliant site specializing in sterile injectable manufacturing. Available capabilities include:

• Aseptic manufacturing of vialed injectables
• Handling of products up to OEB5
• Dedicated support for tech transfer, validation, and scale-up

We support the planning and execution of validation and qualification activities, including:

• Equipment and utility qualification (IQ/OQ/PQ)
• Process and cleaning validation
• HVAC, water systems, and aseptic area qualification
• Regulatory-compliant documentation and protocols

Our team conducts risk assessments (e.g., FMEA) to identify and mitigate critical production risks. We also support the preparation of essential GMP documentation such as batch records, validation protocols, and manufacturing SOPs.

We coordinate or manage GMP-compliant batch analysis at certified laboratories. Our services include release and stability testing for finished products and APIs, aligned with EU and ICH guidelines. Testing covers microbiological, chemical, and physical quality attributes with full data integrity and regulatory documentation.

We offer full regulatory support across the lifecycle of your pharmaceutical product — from early development strategy to market authorisation and post-approval variations. Our experienced team navigates the complexity of regulatory procedures in both the European Union and Brazil, ensuring compliance, speed, and clarity every step of the way.

We prepare complete CTD/eCTD dossiers for submissions in the EU and Brazil, covering Modules 1–5. Our team ensures your data is scientifically sound, regulator-ready, and tailored to local authority expectations — whether for new MAAs, line extensions, or reformulations. We manage full lifecycle dossiers across a wide range of product types including generics, hybrids, and complex formulations.

We handle submissions to EU national agencies, EMA, and Brazil’s ANVISA, including:

• Filing of initial MAAs
• Management of variations (Type IA/IB/II or equivalent)
• Renewals
• Sunset clause prevention (EU)
• Ongoing regulatory tracking and lifecycle management

We represent clients in centralized, DCP, MRP, and national procedures in the EU, and guide you through Brazilian-specific regulatory pathways

We support your development with strategic regulatory input from day one.
Services include:

• Procedure selection and roadmap planning
• Scientific advice briefing packages and meeting support
• Classification and borderline assessments
• Regulatory risk mitigation and market-entry strategies for the EU and Brazil

We coordinate and draft responses to questions from health authorities in both the EU and Brazil. Our proactive approach minimizes delays and helps keep submissions on track — from validation to final approval.

We prepare and review:

• SmPCs, PILs, and packaging texts (EU-compliant)
• Brazilian equivalents per ANVISA’s standards
• QRD templates, readability user testing, and translation alignment

We compile, format, validate, and publish eCTD/NeeS dossiers in accordance with EU and ANVISA requirements — including baseline submissions, sequence validation, and regulatory software management.

We monitor legislative changes, regulatory updates, and authority communications in both the EU and Brazil — so you stay compliant, competitive, and informed.

We offer expert toxicological support across the entire product lifecycle — from early development and dossier preparation to cleaning validation and environmental risk assessments. All preclinical and toxicology studies are conducted within the European Union in certified GLP laboratories to ensure full compliance with ICH, REACH, and VICH guidelines. For clinical development phases, we collaborate with trusted CRO partners in the EU, Asia, USA, Canada, and Brazil to ensure consistent quality and global coverage.

We design and coordinate the full range of preclinical toxicology studies, including:

• Acute, sub-chronic, and chronic toxicity
• Genotoxicity, carcinogenicity, reproductive and developmental toxicity
• Systemic exposure and local tolerance evaluations
• NOAEL definition and PDE (Permitted Daily Exposure) calculations

All studies are executed in the EU, under GLP, and suitable for inclusion in EU and international regulatory dossiers.

We manage Environmental Risk Assessments in accordance with EU and VICH guidelines, supporting both human and veterinary medicines. Our services include:

• Phase I and Phase II ERA strategies
• Coordination of aquatic toxicity, degradation, and bioaccumulation studies
• Literature reviews and scientific justifications
• Module preparation for regulatory submissions

We provide toxicological justification and documentation for GMP-compliant cleaning validation programs:

• Selection of worst-case products
• PDE-based carryover limits
• Residue and impurity assessments
• Final reporting for regulatory and QA/QP acceptance

Our team supports REACH compliance through toxicological planning, execution, and documentation:

• Data gap analysis and waivers
• Exposure scenarios and risk characterisation
• Study design and coordination
• C&L assessments (Classification and Labeling)

We deliver full-service pharmacovigilance support — from global strategy to local execution — ensuring full compliance with EMA, national EU authorities, and Brazil’s ANVISA. Our system is led by an EU-approved QPPV, supported by a network of local PV contacts in all EU member states and trusted partners in Brazil for seamless safety coverage and reporting.

Our certified EU Qualified Person for Pharmacovigilance (QPPV) provides strategic oversight and compliance assurance across your global product portfolio. We offer:

• Appointment of EU QPPV
• PSMF (Pharmacovigilance System Master File) creation and management
• 24/7 QPPV availability for regulatory authority contact
• Supervision of safety systems, case intake, and reporting compliance

We provide full local PV support through:

• A network of local PV representatives in all EU member states
• Dedicated PV agents and safety contact points in Brazil, aligned with ANVISA requirements
• National literature screening and local case management
• Support during inspections or authority queries at the national level

This ensures seamless alignment with both EU GVP and Brazilian PV legislation, including local reporting obligations.

We handle all operational pharmacovigilance activities for investigational and marketed products:

• ICSR processing and MedDRA coding
• Signal detection and risk-benefit evaluations
• Preparation of PSURs, RMPs, DSURs, and ad hoc safety reports
• Hosting or integration of safety databases (Argus, ArisG, etc.)
• SOP development and PV training for internal teams

We prepare clients for authority inspections and internal audits through:

• GAP assessments and CAPA planning
• PSMF review and documentation readiness
• Mock audits, QPPV interview preparation
• Post-inspection response strategy and regulatory liaison

Our PV team brings cross-functional safety expertise in:

• Sterile injectables
• Biologics and biosimilars
• Small molecules (solid and liquid forms)
• Oncology, infectious diseases, and metabolic disorders