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.read more
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.read more
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.
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.read more
The B&H Consulting team are important members of our project team and it has been a pleasure working with them as we have moved through the different phases of development. On Spinifex's behalf, B&H Consulting has been involved in a submission of a large number of documents to the FDA including our initial preIND meeting request and information pack, IND submission and ongoing documents related to our continuing clinical program. As we move deeper into clinical development, Spinifex will build its in-house team however B&H Consulting will still be the company's Regulatory Affairs department as I don't think I can find a better group of professionals.
Tom McCarthy, Ph.D.
Chief Executive Officer & Managing Director
Spinifex Pharmaceuticals Pty Ltd
We are very pleased with the excellent services B&H has provided over the past year. The B&H staff is very professional, collegial and highly qualified to handle multiple regulatory tasks in an efficient and skillful manner. They have been very supportive and committed in the process of preparing and submitting an IND. The regulatory strategic guidance they have provided has been very valuable. They are very responsive and respectful of their client’s timelines. I can highly recommend the B&H team!
Helena Brink Nilsson
Senior Regulatory Affairs Manager, Clinical Development
In addition to key advice on various aspects of US regulatory requirements, B&H assisted us in the detailed preparation, execution and follow-up of a very successful Pre-submission Meeting with the OGD. At all levels – strategic, tactical, operational and administrative – their advice, input and conduct were exemplary and invaluable.
Head of Regulatory Affairs
During the several years that B&H Consulting Services prepared scientific documents, INDs, NDAs and amendments for projects with which I was associated, one could not have asked for more from a consulting company in the area of CM&C document preparation. The quality of the work, the responsiveness to changing needs, the adherence to milestones and deadlines were superb and contributed immensely to the successful registration of a number of products in an expeditious manner. B&H is a unique consulting company to the pharmaceutical industry which provides valuable services to clients.
Irwin S. Gibbs, Ph.D.
Director of Pharmaceutical Development
ExpertiseStrong scientific and business background along with hands-on experience to support your regulatory needs.
On-time Delivery/Submission SupportProven track record with coordination, compilation, publishing and submission of eCTD and paper submissions.
ComplianceThrough 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 WritingB&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.