FAQ

FAQ


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General


Most have held positions within FDA and/or were senior leaders within the biopharmaceutical industry, and have played instrumental roles in crafting the policies and procedures used today. The majority of our consultants have terminal degrees in the sciences or medicine and all are hands-on professionals with an intimate knowledge of the scientific, regulatory and business challenges that must be overcome in order to bring a new product to market. Additionally, our consultants have knowledge needed for post-approval support, Phase IV commitments, and new indications for already approved new drugs/biologics.

Several of our consultants and staff members have experience addressing ex-U.S. issues, however when a deeper level of international expertise is required we engage our international network of in-country affiliates to provide additional support.

Contact us on our website or by calling - 703.739.5695 and explain your requested services. We will assign a team lead to scope out the project with you and provide a detail project proposal to initiate work.

Yes. When a deeper level of international expertise or market submission is required, we engage our international network of in-country affiliates to provide additional support.

Yes, we have professional and specially trained Regulatory Project Managers on staff.

We assign a primary consultant or team but have the capacity to make alterations to that team to suit the project's needs and timelines. Our goal is to maintain a sense of continuity during the engagement and ensure that the best insights and contributions are provided to our clients.

Yes, Biologics Consulting is made up of experts in multiple specialties and thus your assigned person/team can make use of the team's knowledge, as well as company-wide expertise.

Our rates reflect the quality and expertise we will provide to your organization; they are competitive with market standards. For more information, please contact us on our website or call 703.739.5695.

We currently serve as the U.S. Agent for over 100 applications including pre-INDs, INDs, BLAs, NDAs, ANDAs, Master Files (MFs), Orphan Drug Designations (ODDs) and RAC submissions. Sponsors hiring Biologics Consulting as their U.S. Agent can be U.S.-based or non-U.S.-based and are assigned to a Regulatory Project Manager (RPM) who will serve as the main point of contact for both the Sponsor and FDA. RPMs routinely liaise with FDA on behalf of Sponsors, and under the U.S. Agent Agreement will attend up to two type A, B or C meetings per year and take minutes at no additional charge. We maintain a regulatory database in-house for tracking all submissions and correspondence to/from FDA and can run reports on this information as requested.

Yes, our Clinical Trials Planning and Oversight group can assist with selecting a CRO and negotiating contracts with CROs and other clinical vendors.

Yes, our Clinical Trials Planning and Oversight group has extensive experience overseeing clinical studies conducted by CROs. Our consultants can serve as your representative in interactions with the CRO and clinical sites/investigators to ensure the study is conducted in a manner that will generate high quality clinical data that meets the regulatory objectives. Our Analytics Sr. Consultants can oversee the GMP/GLP analytical testing conducted in CRO laboratories.

No, our rates reflect the quality and expertise we will provide to your organization; they are competitive with market standards.

No, we are not a CRO. However, we can help you to identify the most appropriate CRO for your product and organizational needs.

No, we are an independent corporation and our consultants are full-time employees of the company.

Nonclinical and Clinical Development


Yes, Biologics Consulting has extensive experience with scheduling and preparing for pre-IND meetings and IND submissions.

Yes, our consultants are experts in preparing for pre-IND meetings as well as End-of-Phase 1, End-of-Phase 2, pre-BLA/NDA, Type A and Type C meetings. Our clinical consultants work with clients to determine strategically the best clinical questions to be addressed at the FDA meeting, as well as assist with designing the clinical protocol in collaboration with key opinion leaders for the particular indication. Our medical writing consultants have extensive experience with writing FDA briefing packages and clinical protocols.

Yes, Biologics Consulting offers a full suite of clinical trial services designed to ensure successful study outcomes for each of our clients. From designing and overseeing a clinical trial program to serving as an in-house expert on various aspects of the program, our team is able to assist throughout all phases of clinical development.

Yes, our clinical consultants can provide a review of clinical data from the perspective of an FDA clinical reviewer and identify the "red flags" that need to be addressed in presenting the data to FDA.

Yes, our clinical consultants conduct gap analyses/due diligence to clarify the regulatory pathway in the clinical development of a product, as well as assess the pros and cons of potential clinical indications.

Yes, our clinical and medical writing consultants write (or review) clinical sections of BLAs/NDAs. They are familiar with how FDA prefers data to be presented, as well as how to best summarize the data for each of the clinical CTD sections.

The cost of a clinical trial depends on multiple factors, however our Clinical Trials Planning and Oversight group can ensure that you are taking the most appropriate and efficient route to produce the clinical data necessary for FDA approval, thus minimizing your financial and timeline risk. We can work with you, your investigators, and your CRO to ensure a well-designed, well-conducted, and efficient study.

Yes, our clinical consultants are experts at interpreting and responding to FDA's comments.

Quality / CMC / GMP, GCP, GLP, and Pharmacovigilance


Yes, we have consultants who are experienced in preparing Quality System documentation, helping clients conduct mock audits and providing input on post-market strategies, including Medical Device Reporting and Recalls.

Yes, Biologics Consulting has extensive experience with scheduling and preparing for pre-IND meetings and IND submissions.

Yes, our consultants are experts in preparing for pre-IND meetings as well as End-of-Phase 1, End-of-Phase 2, pre-BLA/NDA, Type A and Type C meetings.

Yes, Biologics Consulting has experts intimately familiar with preparing INDs and briefing packages from a CMC, nonclinical and clinical perspective.

Yes, our consultants can provide a review of data from the perspective of an FDA reviewer and identify the "red flags" that need to be addressed in presenting the data to FDA.

Yes.

Yes.

Yes. We can help with method development and validation on-site or remotely.

Device


We have experience across a very broad range of medical device types, including cardiology, general and plastic surgery (including wound dressings and dermal fillers), neurology, anesthesiology, in vitro diagnostics, orthopedics, obesity devices, drug delivery devices (autoinjectors, catheters, implanted pumps), software-based devices and mobile medical apps and tissue-engineered medical devices.

Yes, we are often asked to serve as an FDA contact person for submissions and we frequently meet with FDA on behalf of clients. Our personal familiarity with the FDA process allows us to help our clients navigate and prepare for an FDA meeting, often a critical milestone in medical device development.

Yes. Our team of experienced ex-FDA regulatory consultants has extensive experience in preparing all types of FDA medical device submissions, including 510(k)s, PMAs, IDEs, de novo applications, HDEs, and RFDs. Because all members of the medical device team are former FDA reviewers, we have experience from both sides of the submission and we help our clients prepare applications that are clear, concise and meet FDA's expectations.

Medical Writing and Publishing Services


Yes.

Yes.

Yes.

Yes.

Yes, our Medical Writing group has written successful marketing applications for Europe and Canada. We also have written Clinical Evaluation Reports for medical devices approved in Europe.

Yes, our team has extensive experience in preparing eCopies that meet all of the FDA requirements. We pride ourselves on producing high-quality documents that meet all of FDA's needs and expectations.

Additional Product Expertise


  • Blood-Derived Products
  • Cell, Gene and Tissue Therapy
  • Companion Diagnostics
  • Nutraceuticals and Supplements
  • Drug-Device Combinations
  • Drug delivery devices (autoinjectors, catheters, implanted pumps)
  • In Vitro Diagnostics
  • Orphan Drugs
  • Vaccines
  • Software-based devices and mobile medical apps
  • Tissue-engineered medical devices