Global Regulatory Advisory

A product is moving into new markets, a regulatory framework is changing, or an authority has raised findings. Leadership needs one plan that shows what each market requires, what evidence can be shared, and who is doing the work.

• -Pharmaceutical, biotech, medical device and diagnostics companies entering additional markets
• -Healthcare and regulated technology organizations facing new or changing obligations
• -Regulatory, quality and executive teams that need senior capacity for a defined program
• -Organizations remediating after inspection or audit findings

• -A launch in an additional market is being planned
• -A submission or authority meeting is approaching
• -Regulatory requirements or transition deadlines are changing
• -Authority findings require a credible remediation plan
• -Regulatory intelligence is fragmented across teams or markets

• -Regulatory strategy and market-entry planning across target markets
• -Submission planning, preparation support and review
• -Regulatory intelligence: monitoring changes and assessing their impact
• -Lifecycle obligations: post-market requirements, changes and renewals
• -Remediation planning and execution after authority findings
• -Coordination of shared evidence and market-specific work across jurisdictions

• -Regulatory map by market: classification, route, evidence and obligations
• -Submission plan and review comments
• -Regulatory gap assessment with priorities
• -Regulatory intelligence briefings and impact assessments
• -Remediation plan with owners and dates
• -Regulatory decision log shared across markets

1. 01Map. Establish the frameworks, routes, evidence and obligations for each target market.
2. 02Plan. Separate shared evidence from market-specific work and sequence it against business milestones.
3. 03Execute. Prepare documentation, support submissions and carry out remediation with your team.
4. 04Maintain. Monitor regulatory change and keep the decision log and obligations current.

Each cross-border engagement has one accountable lead who owns the overall plan and the decision log. Market-specific work is assigned to practitioners with experience of that framework, and shared evidence is planned once. The frameworks listed on this site describe service coverage; they do not imply local offices.

Each engagement is led by a senior BiggsB practitioner with experience of the relevant regulatory framework, supported by specialists from the supporting capabilities as the scope requires.

BiggsB advises and supports; submissions and regulatory commitments remain the responsibility of the authorization holder. We do not provide legal representation before authorities, and we work alongside your legal advisers and local representatives where a market requires them.

How does BiggsB coordinate work across several markets?

One accountable lead owns the overall plan and a shared regulatory decision log. Evidence that serves several markets is planned once; market-specific work is assigned to practitioners who know that framework.

Which regulatory frameworks do you work with?

Our current service descriptions cover US FDA requirements, EU frameworks including EMA procedures, GMP Annex 11, GDPR and the EU AI Act, and international guidance such as ICH. Ask about other markets in an initial conversation.

Can you support a remediation after an inspection?

Yes. We help analyze findings, plan corrective actions, draft responses for your review and carry out the remediation with your team. Our quality and GxP capability supports this work.

• Global Program & Project Management — global-program-management
• Preclinical & Clinical Regulatory Support — clinical-preclinical
• Quality Systems, GxP Operations & Inspection Readiness — gxp-clinical-operations

Use the inquiry form, email connect@biggsb.com, or book a call.

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