Regulatory Support in Somerville, NJ

Delivering Unsurpassed Attention to Your Regulatory Needs

Our Professionals Become Your Experts

DELIVERING UNSURPASSED ATTENTION TO YOUR Regulatory Needs

Our Professionals Become Your Experts

WORKING ON YOUR REGULATORY NEEDS

Turn to B&H Consulting Services, Inc., located in Somerville, New Jersey, to be guided in handling all your regulatory requirements. Since 1988, our experienced staff has been providing a comprehensive range of assistance to the health sciences industry.

STRATEGIC AND OPERATIONAL EXPERTISE

Our technical team has an in-depth understanding of the drug and biologics development process. This allows us to conduct a critical assessment of your project and provide strategic and operational guidance on how to move forward within the constraints of compliant documentation and regulatory procedures. Our regulatory operations and document management staff will provide the expertise needed for all regulatory submissions.

GLOBAL REGULATORY EXPERIENCE

At our company, we are committed to meeting each client’s global regulatory needs by delivering unsurpassed attention. You can rely on us to provide the following:

Proven Regulatory Expertise
Chemistry, Manufacturing and Controls (CMC) Technical Writing Support
US/Regulatory Agent Services
Effective Preparation and Coaching for Sponsor/FDA Meetings
Electronic Submission Capability

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SUBMISSION SUPPORT

Regardless of the type of submission, our document management specialists and regulatory operations/eCTD teams work efficiently to compile and publish quality submissions. With an eye to the impact of the biopharma industry of patients, our goal is to assure the timely completion of quality submissions in the spirit of partnering with our clients to bring new or enhanced products to the global marketplace.

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TEAM APPROACH

Each project is supported by a technical team member and a document management team member chosen to best meet the client’s goals and objectives. 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. This will allow us to provide services in a manner that fosters a partnership with each client.

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Connect With Us

Let our professionals help and attend to all your regulatory needs. For additional information on how we can assist you, please contact B&H Consulting Services, Inc. today. We look forward to serving you!

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