Consultancy

Expert Support for Quality and Compliance

We offer integrated expertise in regulatory affairs, pharmacovigilance, quality assurance and laboratory services. From import and release services to maintaining compliance with global standards, we ensure your pharmaceutical products meet the highest quality benchmarks.

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Overcoming Key Challenges in Pharmaceutical Consultancy

  • Regulatory Affairs​

    Expert regulatory affairs support helps navigate complex regulatory requirements and ensures compliance throughout the product lifecycle.

    Our services include advice on regulatory strategy and EU legislation, including regulatory due diligence and registration dossier assessments, supporting informed decision‑making and successful submissions.

  • Pharmacovigilance services​

    Pharmacovigilance support ensures the ongoing safety of products and compliance after market entry.

    Our services include the set‑up and maintenance of pharmacovigilance systems, required documentation, and safety monitoring during clinical studies and post‑authorisation use, supporting informed decision‑making and regulatory compliance.

  • QP release of the Drug Product

    GMP‑compliant final batch release is a critical step in ensuring product quality and regulatory compliance.

    Our services include independent QP review of the product and Product Specification File (PSF), covering both commercial and non‑commercial batch releases.

Discover Our Full Range of Quality and Regulatory Services

For a full overview of our quality and regulatory services, including import and release, visit our subsidiary Interdos.

Qualified Person & Responsible Person ​

Qualified Person (QP) and Responsible Person (RP) support ensures compliance with Good Manufacturing Practices (GMP) and the effective operation of robust quality systems.

Our services and consultancy support include:

  • Quality Management System (QMS); Setup, Implementation, and Maintenance
  • GMP Implementation and ongoing Compliance Support
  • Auditing, Monitoring, and Training Activities
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Drug-Device Combinations

Regulatory and quality systems support is provided for drug–device combinations to ensure compliance with applicable medical device and pharmaceutical requirements.

  • Delivering a person responsible for regulatory compliance (PRRC) to your company
  • Regulatory Consulting for Drug–Device Combinations
  • Quality Systems Consulting
  • ISO 13485 Gap-Analysis
  • ISO 13485 Audits
  • Compilation of CE Technical Documentation and Product Dossiers
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Dedicated Consultancy for Your Success

Contact us today for expert consultancy addressing your pharmaceutical needs and challenges.