Regulatory Affairs Consulting

Our regulatory affairs consultants can help you devise effective regulatory strategies to place you on the best path toward regulatory approval, helping you avoid regulatory delays and overcome critical regulatory hurdles. We also provide hands-on support, including assistance with regulatory applications and eCTD publishing. Our experts can work alongside and supplement your internal regulatory teams to solve bandwidth challenges. We can also provide interim regulatory affairs leadership during periods of transition. Additionally, our team conducts regulatory due diligence both for internal purposes as well as for external parties engaged in licensing, investment, and M&A activities. 

Each member of our team brings significant industry experience from a career either working within regulatory agencies or with shepherding pharmaceutical and biotech products through regulatory processes. We have extensive expertise with both FDA and EMA regulations and many years of experience interacting with those regulatory bodies.

Our group has deep preclinical, CMC and clinical regulatory experience covering a broad range of therapeutics including small molecules, biologics, and ATMPs such as cell and gene therapies. By combining our core team with the extensive capabilities of our specialized consulting network, we're able to provide regulatory support that is precisely tailored to the exact regulatory needs of your project, throughout the product development cycle.

Regulatory consulting services we provide:

More specifically, a regulatory feasibility study assesses your regulatory strategy and plans, including proposed timelines and costs, to ensure they are accurate and on target. Our assessments help clients ensure regulatory expectations are not only reasonably set and achievable, but that the chosen path is the most efficient one leading to the fastest approval.

As part of this, our regulatory affairs consultants also recommend the best path forward to approval, including any expedited pathways such as Fast Track or PRIME that your program may qualify for. Our expertise covers both the FDA and the EMA, and we have consultants who specialize in a range of technologies and therapeutic areas.

We perform regulatory due diligence both for internal purposes as well as for outside parties engaged in licensing, investment or M&A activities. The objective is to uncover any red flags that may affect the general success of the regulatory strategy and consequently, current clinical and commercial plans.

Our regulatory team can help you prepare for an upcoming IND submission, including both strategic and hands-on support for initial meetings with the FDA or EMA. Within our Expert Network, we have consultants who specialize in each critical aspect of IND-readiness, including toxicologists and pharmacologists, who can review preclinical studies to ensure they will meet FDA/EMA expectations.

We also advise clients on the meetings themselves, including with crucial items such as how to best structure questions. In addition, we can attend meetings with you, as well.

We can advise you strategically on how best to approach applying for an expedited program or an orphan drug designation. We are also able to provide hands-on support with the application process itself, including with appealing decisions.

We can provide hands-on support for CTA and IND submissions, ranging from high-level guidance and review to our team fully preparing and managing the submission, including writing and publishing eCTD-compliant IND package documents.

 

What sets us apart


In addition to our core team, we draw from a 500-member expert network of senior-level, functional specialists, whose capabilities span each major discipline involved in drug development. Located in both the US and Europe, our network includes over active 45 regulatory affairs consultants, many of whom specialize in particular disease areas and product modalities.  

  • Autoimmune/Immunology
  • Cardiovascular
  • Central Nervous System
  • Congenital Disorders
  • Dermatology/Aesthetics
  • Digestive/GI
  • Ear
  • Endocrine and Metabolic
  • Fibrosis
  • Genitourinary Diseases
  • Haematology
  • Infectious Disease
  • Inflammation/Pain
  • Injuries and Trauma
  • Musculoskeletal
  • Non-medical
  • Oncology
  • Ophthalmology
  • Orphan Diseases
  • Respiratory
  • Urology (non-onc)
  • Women’s Health
  • Imaging
  • Immunotherapy
  • Medtech
  • Microbiome
  • Oncolytic Virus
  • Peptides
  • Proteins
  • Radiopharmaceuticals
  • Small molecules
  • Vaccines


Selection of Recent Projects:


  • Regulatory due diligence for a clinical-stage biopharmaceutical: A clinical stage biopharmaceutical specialist needed support with its regulatory due diligence activities. We assembled an expert team comprising an ex-quality assessor who had previously worked in the biologicals unit at the MHRA (primarily on EMA-centralized procedures), and an ex-Senior Director and ex-Medical Advisor for a biotechnology company. The team reviewed all correspondence with regulatory authorities to identify any red flags that needed to be addressed.

  • Successfully appealing FDA refusal of an orphan drug designation application: A biopharmaceutical company was seeking assistance to prepare a response to the FDA’s initial refusal of its orphan drug designation application for its novel CAR-T therapy intended for use in an orphan subset of a non-orphan condition.

  • Supporting medical device 510(k) submissions: A company had successfully CE marked a novel lung function device, and the next step in the commercial strategy was to obtain 510(k) clearance to market in the USA. This was a complex submission that required careful planning in order to expedite the approval process while at the same time maximizing its use over a number of potential measurement parameters

  • Supporting a CTA submission for the oral form of an approved biologic drug: Our client was developing an oral form of an approved biologic drug which appeared to have excellent properties in terms of a rapid time to maximum concentration in the blood. A Phase II trial in an orphan indication was underway in the client's home country and the company intended to open a UK trial site as soon as practicable.

  • BLA submission support: Our client was nearing the completion of a pivotal Phase III trial with a novel antibody-based therapeutic. The product was designed to delay recurrence in cancer patients with minimum residual disease following debulking surgery and standard chemotherapy. The Phase III trial design had been agreed with the FDA under the SPA procedure and the client had gained fast-track status. In addition, the client had received EMA scientific advice and intended to file for conditional MAA approval, subject to satisfactory Phase III results. Although our client was a fully integrated pharma company, and had significant regulatory experience with small molecules, this was the company’s first biological product candidate to reach the registration stage. The company was therefore seeking to supplement its existing in-house capabilities with the appropriate external biologics regulatory expertise. Specifically, the company needed to gain a better understanding of the BLA process, clarify the level of detail needed for the various sections of the license application and obtain high-level review and sign-off of the regulatory dossier.

  • Pre-IND meeting support with the FDA: Our client was developing an oral form of an approved biologic drug for endocrine disorders which appeared to have excellent properties in terms of a rapid time to maximum concentration in the blood. A Phase II trial in an orphan indication was underway in the client's home country. The client also intended to submit an IND in the US to develop the drug there, and engaged Alacrita for support with a preparation and execution of a pre-IND meeting with the FDA.


Selection of Case Studies:

Challenge: Our client is an innovative, publicly-traded, lean biotechnology company focused on developing potential cures for infectious diseases and cancer utilizing cell and gene therapies and proprietary platform technologies. The primary infectious disease target is Human Immunodeficiency Virus (HIV). There are numerous cancer targets, focused on hard-to-treat solid tumor indications where, currently, Chimeric Antigen Receptor (CAR) technologies have faced numerous challenges. 

Alacrita was engaged to provide cell and gene therapy regulatory affairs consultant support for Chemistry, Manufacturing & Controls (CMC), and Pharmacology & Toxicology to help support and accelerate client Research & Development (R&D) activities.

Solution: Alacrita's cell and gene therapy regulatory affairs lead consultant has over fifteen years' experience working in this field, both with the FDA as a senior regulatory specialist and subsequently within the pharmaceutical industry developing novel cell therapies. Our regulatory affairs team worked with the client to develop a regulatory strategy for its lead cell therapy product, as well as additional products in the pipeline. 

Other members of our consulting team were then integrated into the client R&D Team and their external contract organizations to ensure a smooth implementation and oversight of the strategy. For the lead drug, Alacrita's regulatory affairs expert supported the client with the management of contract manufacturing organization relationships, strategic support and implementation of manufacturing process and analytical method development and optimization, strategic support and implementation of Investigational New Drug (IND)-enabling in vitro and animal studies, as a regulatory liaison for first-in-human clinical trial design and associated information client education on FDA requirements, meetings/interactions and submissions for cell and gene therapies.

Challenge: Our client is a leading T Cell Receptor (TCR) biotechnology company, focused on delivering first-in-class biological therapies for serious diseases. The client wanted to understand whether it had the capabilities to launch its lead product if it were to receive accelerated approval without partnering with larger companies and asked Alacrita for commercialization assistance. The overall objective of the project was to ensure the client was adequately prepared for the eventuality of an early commercialization event for the product. This included an assessment of the regulatory pathway for the product and any obstacles that had to be considered.

Solution:

Our assessment comprised three umbrella categories:

  • Marketing approval pathway and data requirements: As a prerequisite for commercialization, the marketing approval pathway and data requirements were evaluated based on the sponsor’s interactions with relevant regulatory authorities and development plans. Having a preferred marketing approval pathway agreed with the agency(ies) and well-defined data requirements and desired labelling for the application reduces risk to achieving a timely approval and, in turn, market launch, for a commercially viable product.

A written report was provided to the client summarizing the findings from each analyses and highlighting areas for focus as they work towards.

FDA cell therapy regulatory affairs consulting

Challenge: A company developing a first in class allogeneic Natural Killer (NK) cell therapy needed regulatory support for its FDA interactions. The product was in early clinical trials in an ex-US territory and had shown preliminary evidence of efficacy. The company was looking at establishing an IND to enable further clinical development in the United States. Alacrita was engaged to help with this process.

Solution: Alacrita's cell therapy regulatory consultant, who had worked in the FDA and industry, provided strategic advice to the company as it planned for the IND submission. Deliverables from the work included the development and implementation of an overarching FDA strategy, advice on the CMC regulatory strategy (e.g. comparability exercises) and support with the pre-IND meetings, IND submissions and expedited pathway designation applications such as Fast Track, RMAT and Breakthrough.