Industries
Life sciences, healthcare and regulated technology
BiggsB's established strengths are in life sciences, healthcare and regulated technology, where regulatory obligations shape product strategy, transactions and operations.
Life Sciences
Pharmaceutical, biotech, medical device and diagnostics companies, and the clinical research organizations that support them, from development through submission, manufacturing and post-market obligations.
Selected pharmaceutical experienceBiggsB has delivered global project management engagements for Roche, Pfizer and GSK. Global Program & Project Management
Organizations we work with
- Pharmaceutical and biotech sponsors
- Medical device and diagnostics manufacturers
- Clinical research organizations
- Software and cloud providers serving GxP customers
Questions clients bring
- Which markets to enter, in what order, and with what evidence
- How to prepare for submissions and inspections
- How to validate GxP systems, including AI-enabled systems
- How to run a global program across functions, sites and countries
- How to integrate quality systems after an acquisition
Relevant expertise
- Global Regulatory Advisory
- Mergers & Acquisitions in Regulated Industries
- AI Regulation & Governance
- Global Program & Project Management
- Computer System Validation & Computer Software Assurance
- Preclinical & Clinical Regulatory Support
- Quality Systems, GxP Operations & Inspection Readiness
- Veeva Implementation & Administration
Healthcare
Healthcare organizations that handle patient data and adopt AI and digital services under privacy, security and clinical governance obligations.
Organizations we work with
- Health systems and providers
- Healthcare payers
- Digital health and health technology companies
Questions clients bring
- How to govern AI used in clinical and operational workflows
- How to meet HIPAA and GDPR obligations for patient data
- How to assess regulatory and compliance risk in a healthcare acquisition
Regulated Technology
Technology companies whose products are used in regulated settings, or are regulated themselves, and that must show customers, auditors and investors how their systems and AI are controlled.
Organizations we work with
- SaaS and cloud platforms used in GxP and healthcare environments
- AI product companies serving regulated customers
- Investors evaluating regulated technology companies
Questions clients bring
- Which AI rules apply to the product and in what role
- What validation evidence regulated customers will expect
- How compliance maturity affects a financing or sale
Regulatory frameworks
Service coverage, not office locations.
- United States — FDA and HHS frameworksIND and NDA support; 21 CFR Part 11; HIPAA
- European Union — EMA and EU frameworksCTA and MAA support; EU GMP Annex 11; EU AI Act; GDPR
- International standards and guidanceICH guidelines; GAMP 5 and computer software assurance principles; ISO/IEC 42001 and NIST AI RMF for AI governance
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