Services that Create Operational Excellence

Tailored Solutions for Healthcare Regulatory Services Needs.


At Pierce & Biersadorf Consulting we can resource any project for the pharmaceutical industry – regardless of size and timescale. From filing submissions to the more complex management of compliance issues and post-licensing activities, we are the experts in this field and can supply the market intelligence and consultants to match any Regulatory Affairs need – anywhere in the world

We are always up to date with current legislation, regulatory requirements, industry initiatives and interpretations of the regulations. Our team is comprised of consultants with experience in all aspects and at all levels of Regulatory Affairs in worldwide markets.

Our top consultants are also experienced project managers and will work with you to ensure all aspects of a project are managed and communicated effectively.


Pierce and Biersadorf's complete spectrum of regulatory and compliance services include compliance evaluation, critical issue remediation and resolution, risk assessment analysis, supporting system design and deployment, gap analysis, publishing, pharmacovigilance, post-marketing management, and much more. Yet helping clients meet regulatory obligations is only the beginning of our services. On the path to regulatory compliance, we identify areas where operations and processes can be improved with simple, cost-effective solutions, ensuring maximum efficiency and quality along with product and regulatory integrity. Our service team members can assist with projects of any scale or length, whether on-site or remote, domestic, international, or multinational. If your company needs regulatory consulting assistance anywhere in the world, learn more about the compliance services Pierce & Biersadorf can offer.

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