Expertise

Our Professionals Become your Experts

Delivering

Unsurpassed Attention to your Global Regulatory Needs

Service

Personalized and Focused

Strategic & Operational Expertise

B&H Consulting Services, Inc.'s technical team, with in-depth understanding of the drug/biologics development process, can conduct a critical assessment of your project and provide guidance on how to move forward within the constraints of regulatory procedures and compliance. Our regulatory operations and document management staff provide expertise and operational support for all regulatory submissions.

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Global
Regulatory
Affairs

B&H delivers unsurpassed attention to your Global Regulatory needs. The B&H team provides proven Global Regulatory Affairs expertise, electronic submission capability, CM&C technical writing support, US / Regulatory Agent services, and effective preparation and coaching for Sponsor/FDA meetings. We are committed to meeting each client’s needs.

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Team
Approach
 

Each project is supported by a B&H technical team member, a document management team member chosen to best meet the client’s goals and objections. We involve other staff members with specific expertise, educational background and prior work experience on an as-needed basis to assure the optimum team for your project.
Our services are provided in a manner that fosters a partnership with our clients.

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Submission
Support
 

Whether paper or electronic, our document management specialists and/or regulatory operations eCTD team works efficiently to compile and publish quality submissions. Our goal is to assure the timely and quality completion of all submissions, in the spirit of partnering with our clients, in order to bring new products to the global marketplace.

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Testimonials

The B&H Team Provides:

Expertise

Strong scientific and business background along with hands-on experience to support your regulatory needs.

On-time Delivery/Submission Support

Proven track record with coordination, compilation, publishing and submission of eCTD and paper submissions.

Compliance

Through knowledge of FDA/ICH regulations and guidelines allow B&H to provide regulatory guidance across a product’s life-cycle at the strategic and operational levels.

CM&C Technical Writing

B&H team includes a core group of CM&C specialists to support pre-marketing drug development, marketing applications and post-marketing line extensions and life-cycle management.