Self Assessment

This offers a clear, structured pathway to identify regulatory requirements, assess compliance gaps, guide documentation and certification needs, and map out the steps for a safe and compliant product launch.
Why perform a
Self-Assessment?

Before launching a new product, regulatory self-assessment helps determine classification, applicable regulations, and compliance obligations. It helps you avoid costly mistakes, reduce market delays, and ensure safe, compliant market entry. 

At INTER REGULATORY, our Self-Assessment service gives you a practical, structured path to understand regulatory requirements, and helps guide you whether you can self-certify or need full regulatory support. 

What We Offer

Regulatory Applicability & Classification Review

We analyse your product and its intended use to determine which regulatory frameworks apply (e.g., medical device regulations, cosmetic regulation, PMTA/TPD dla vape, consumer product safety, novel-food regulation).

We identify relevant directives, regulations, and standards for your target markets (EU, UK, US, others).

Declaration of Conformity & Regulatory Status Advice

Based on the results of the self-assessment, we advise whether you can proceed with self-certification (if allowed) or whether the product requires involvement of a notified/authorised body.

We prepare a draft declaration of conformity template and advise on correct marking/labelling (CE, UKCA, etc.) for your product.

Gap Analysis & Compliance Checklist

We perform a detailed gap analysis: comparing your product’s design, composition, labelling, claims, instructions, safety data, etc., against the identified requirements.

You will receive a clear checklist summarising missing documentation, required tests, labelling, manufacturing or quality-system steps, and other compliance obligations.

Regulatory Risk & Compliance Roadmap

We summarise the regulatory risks associated with your product, non-compliance risks, market surveillance, quality system gaps, and deliver a roadmap of recommended next steps (testing, documentation, audits, lifecycle follow-up).

Technical Documentation / Technical File & Dossier Guidance

We outline what technical documentation or dossier your product will need, including safety data, risk assessments, product specifications, labelling and instructions, quality-system evidence, manufacturing controls, etc.

We provide guidance on how to compile or update your technical file to meet regulatory requirements.

Optional Follow-Up & Full Consultancy

If desired, you can request full support to complete the regulatory compliance process: from documentation and submissions to ongoing lifecycle management and post-market surveillance.