Your Trusted Source of Regulatory Support

Regulatory Strategy/Agent Support

Guided by our in-depth knowledge of the integrated drug development process, B&H can partner with or lead your regulatory efforts across a product's lifecycle at both the strategic and operational levels. B&H currently represents more than 50 companies as designated US or Regulatory Agent. We interact with FDA on our client’s behalf and provide regulatory affairs support.

Regulatory Support

Our team members have a strong scientific background, through knowledge of FDA/ICH regulations and guidelines and hands-on experience to support your regulatory needs across a product’s lifecycle.

Let our team support your regulatory needs at both the strategic and operational levels:

Provide expert advice on regulatory strategy across all phases of development.
Deliver critical review and/or preparation, technical writing, and assembly of:
- Investigational product applications
- Marketing submissions suitable for FDA as well as Global Health Authorities
Handle day-to-day regulatory operations to assure compliance.
Liaise with FDA to expedite drug development and marketing approvals and resolve issues.
Prepare Fast Track and Breakthrough Therapy Designations.
Support Orphan Drug Designation Applications
Compile and review labeling including PLR format; collaboration with outside vendor for labeling conversion to SPL format.
Prepare/submit electronic Labeler Code Requests, Establishment Registrations/Renewals and Drug Product Listings (eDRLS).

FDA Meeting Support

B&H has coordinated and participated in more than 400 formal, face-to-face and teleconference meetings, as well as informal teleconferences with FDA, including all meeting types at all phases of development.

Prepare meeting requests and background documents; critically assess questions and development program to ensure background information is complete.
Facilitate the details and organize the meeting with FDA.
Conduct and lead rehearsals in preparation for FDA/Sponsor Meetings.
Prepare Sponsor meeting minutes for submission to Health Authority.

CHEMISTRY, MANUFACTURING, AND CONTROLS TECHNICAL SUPPORT

The B&H team includes a core group of CMC specialists who provides CMC regulatory strategy and technical writing expertise to support pre-marketing drug development, marketing applications and post-marketing line extensions and lifecycle management.

We successfully manage the coordination, technical writing and compilation of Chemistry, Manufacturing and Controls (CMC) documentation for applications submitted to United States, Canadian and European Health Authorities, ensuring that all information is accurate, complete and meets currently acceptable standards, (i.e., ICH, 21 CFR, etc.).

We provide the following CMC-related activities:

Prepare, assemble and review CMC sections for investigational and marketing applications filed to regulatory authorities across all type of drug/biologic products and applications (INDs, NDAs [505(b)(1), 505(b)(2)], BLAs, ANDAs, DMFs).
Conduct CMC gap assessment.
Prepare responses to CMC-related queries from health authorities.
Assess change controls and provide submission strategy.
Lead Agency meeting preparation.
Prepare CMC section for annual reports.
Post-approval maintenance and lifecycle management.
Management of control correspondences.

Electronic Submission Support

B&H has complete electronic submission capabilities to meet global eCTD requirements. We utilize docuBridge, a cost effective and compliant solution for electronic submissions. Our in-house experts have a proven track record with coordination, compilation, publishing and submission of initial eCTDs as well as supporting the eCTD lifecycle management. B&H has an approved WebTrader account and regularly sends submissions through the Agency’s Electronic Submission Gateway (ESG).

Submission Services via FDA’s ESG:

Investigational New Drug Applications (IND) and Amendments
New Drug Applications (NDA), Biologics License Applications (BLA) and Abbreviated New Drug Applications (ANDA)
IND, NDA, BLA, DMF and ODD Annual Reports
DSURs/PSURs/PADERs
Drug Master Files and Amendments/Updates
Labeler Code Registrations
Establishment Registrations and Drug Listings
Structured Product Labeling (SPL) Coordination and Submission

Submission Services via FDA’s CDER NextGen Portal:

Control Correspondence
Orphan Drug Designation Applications

REGULATORY LIFECYCLE MANAGEMENT

B&H helps to assure that our clients are compliant with various regulations such as US 21 CFR 312, 314, 316 and 600.

B&H supports lifecycle management (LCM) services for many products including those that we are designated US or Regulatory Agent. Aside from the annual and quality updates, B&H provides support for all electronic Drug Listing and Registration (eDRLS) activities including Labeler Code Request, Establishment Registration and Drug Listing support in accordance with 21 CFR 207.

Additionally, B&H provides assessment of change controls to determine reporting categories of Chemistry, Manufacturing and Controls information in approved NDAs and ANDAs, as well as assesses DMF updates and their impact/potential reporting requirements for NDAs and ANDAs. We prepare, assemble and/or critically assess the quality updates to ensure submission compliance.

Worldwide Support

B&H, in partnership with Voisin Consulting Life Sciences, can provide regulatory and submission support throughout Europe.