Regulatory Affairs Consulting: Your Partner in Compliance and Market Success

Regulatory challenges shouldn’t slow down your progress. At Excellence Squad, we help life sciences companies cut through complexity, eliminate roadblocks, and achieve compliance with confidence. From regulatory strategy to global submissions, our tailored solutions ensure a seamless approval process—so you can bring safe, effective products to market faster.

Whether you need support with FDA, EMA, MDR/IVDR, or other global requirements, our experts provide clear, actionable guidance to minimize risks and keep your projects moving forward.

Explore our services below to see how we can support your regulatory journey and drive your business success.

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Regulatory Strategy Development

Tailored strategies to navigate the complex regulatory landscape for pharmaceuticals, medical devices, and biotech, ensuring a clear pathway to compliance and approval.

Market Authorization Support

Assistance with regulatory submissions, including FDA, EMA, TGA, Health Canada, and others. Expertise in PMA, 510(k), DeNovo, CE Mark, and IVDR to streamline approval processes.

Gap Analysis and Compliance Assessment

Comprehensive evaluation of regulatory gaps and actionable recommendations to align with global standards, reducing compliance risks.

Regulatory Dossier Preparation

Preparation of detailed regulatory dossiers and technical documentation necessary for product approvals, tailored to meet specific agency requirements.

Regulatory Intelligence

Monitoring and analyzing global regulatory changes and trends to keep clients informed and proactively address emerging challenges.

Person Responsible for Regulatory Compliance (PRRC) Services

• Offer Interim PRRC Services to ensure compliance with EU MDR/IVDR requirements, including oversight of technical documentation, post-market surveillance, and regulatory reporting.
• Support organizations during regulatory audits, transitions, or expansions to maintain compliance and market access.

Notified Body Interaction

Managing communications and submissions to Notified Bodies for CE Marking and other related activities, ensuring smooth approval processes.

Clinical Trials Regulatory Support

Guidance on regulatory requirements for clinical trial design, execution, and data management, ensuring compliance with global standards.

FDA 483/Warning Letter Response Support

Expert management of responses to FDA 483 observations and warning letters, ensuring timely compliance and risk mitigation.

Global Regulatory Support

Providing international regulatory strategies and submissions for regions including Latin America, Asia, and beyond, addressing regional requirements effectively.

EUDAMED Compliance and UDI Support

Comprehensive support for compliance with EUDAMED and Unique Device Identification (UDI) requirements, ensuring seamless regulatory integration.

GDP Compliance for Distribution Activities

Support for implementing Good Distribution Practice (GDP) regulations for pharmaceutical products, including storage, handling, and transportation.

GLP Compliance

Ensuring compliance with Good Laboratory Practice (GLP) for regulatory submissions, supporting reliable and consistent laboratory data.

Market Access Strategy Development

Developing tailored strategies to navigate international market access for life sciences products. Services include identifying local regulatory hurdles, optimizing time-to-market, and ensuring compliance with regional standards.

Post-Approval Compliance

Ongoing regulatory support after product approval, including adapting to regulatory changes, maintaining certifications, and updating marketing authorizations.

Regulatory Affairs for Software as a Medical Device (SaMD)

Guidance on regulatory pathways for software products in the healthcare sector, ensuring compliance with MDR, FDA, and other global standards.

AI Regulatory Compliance

Strategic guidance for compliance with the EU Artificial Intelligence Act, addressing classification, transparency, and risk management requirements. Supports seamless integration of compliance into development and operations.

Interim Regulatory Affairs Manager Services

Act as an Interim Regulatory Affairs Manager for medicinal products, medical devices, providing on-demand expertise.

Marketing Authorization Management

Preparation and submission of applications for Marketing Authorizations through national, mutual recognition, or decentralized procedures. Services include renewals and variations.

Specialized Legislative Advice

Provide expert advice and interpretation of national and European legislation for effective compliance and strategic planning.

Regulatory Compliance for Combination Products

Support for navigating regulatory requirements for combination products, such as drug-device combinations. Ensure compliance with relevant agencies like FDA and EMA.

Advanced Therapy Medicinal Products (ATMPs)

Assist with regulatory approval and compliance for ATMPs, including gene therapies, somatic-cell therapies, and tissue-engineered products. Ensure these innovative therapies meet EMA and FDA requirements for safety and efficacy.

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