As of April 2025, we are not accepting new clients.

Integrated Support Across the Product Lifecycle

Brighton Ashford LLC provides high-impact consulting services at the intersection of science, regulation, and law. We support pharmaceutical, medical device, and combination product developers and their CRO/CDMO partners with services tailored to ethical product development and FDA approval. Our firm is led by experts with advanced degrees in chemistry and law and decades of practical industry experience.

CRO/CDMO Contracting & Regulatory Compliance

We help CROs, CDMOs, and sponsors optimize their development and quality programs through:

• Drafting and negotiation of MSAs, MQAs, CDAs, SOPs, SOWs, and Quotes

• Auditing internal and third-party processes for cGMP/GLP/ISO compliance

• Advising on regulatory strategies under 21 CFR §§ 353, 355, and 360, USP, EP, ISO, and ICH

• Preparation and review of Module 3 documentation and related filings

• Scientific support for E&L, elemental impurity, method validation, and stability studies

Patent Law & Complex Litigation Consulting

Brighton Ashford also delivers critical technical expertise to support:

• Patent application drafting, USPTO office action responses, and patentability reviews

• Infringement, invalidity, and freedom-to-operate analysis

• Expert consulting for civil litigation, mass torts, product liability, and criminal defense

• Translation of complex scientific data into courtroom-ready arguments

For CROs, CDMOs, life sciences companies, and law firms seeking clarity and expertise in complex technical and regulatory environments, Brighton Ashford is your trusted partner.