Regulatory Consulting

Navigating the GxP regulatory landscape

The pharmaceutical and life sciences regulatory environment is one of the most complex in the world. FDA guidance documents, EMA directives, ICH guidelines, ISO standards and local country regulations form a normative ecosystem that constantly evolves and requires expert interpretation to be correctly applied in each organisation.

Regulatory consulting is not about citing applicable articles: it is about helping organisations understand what each requirement means for their specific processes, how to implement it efficiently and what evidence they need to generate to demonstrate it to an inspector.

Consulting areas

FDA (21 CFR)

Advisory on the interpretation and application of FDA regulations, including:

• 21 CFR Part 11: Electronic records and electronic signatures.
• 21 CFR Part 210/211: Good manufacturing practice for pharmaceutical products.
• 21 CFR Part 820: Quality System Regulation for medical devices.
• Preparation of responses to Form 483 and warning letters.

EMA and European regulations

• EMA GMP Annex 11: Computerised systems.
• MDR 2017/745: European Medical Device Regulation.
• EU GMP Guidelines: Good manufacturing practice guidelines.
• Communication with national European agencies.

ICH Guidelines

Interpretation and application of ICH quality guidelines (Q8-Q14), including:

• ICH Q10: Pharmaceutical quality system.
• ICH Q9: Quality risk management.
• ICH Q12: Lifecycle management of pharmaceutical products.

ISO 13485 and medical device regulations

Advisory on the implementation and maintenance of the quality management system compliant with ISO 13485, including preparation for notified body audits.

Regulatory inspection support

A regulatory inspection should not be a surprise. We support our clients through all phases of the process:

Before the inspection:

• Documentation and system review.
• Mock inspections.
• Staff preparation.
• Back-room organisation.

During the inspection:

• Presence as reference regulatory advisor.
• Coordination of responses for the inspection team.
• Management of document requests.

After the inspection:

• Analysis of observations (Form 483, EIR, EMA reports).
• Drafting of formal responses.
• Corrective action plan (CAPA) for observation closure.

Regulatory gap assessment

How aligned is your organisation with current requirements? We conduct gap assessments against the regulatory framework applicable to your activity, identifying priority risks and the actions needed to achieve and maintain compliance.