First approved application for BioBag® medicinal larvae for Biomonde GmbH
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Ensuring regulatory success
Meetings with Health Authorities such as the FDA in the US, the EMA in Europe or other major Health Authorities worldwide have shown to increase the probability of market approval and can have a most favorable impact on development times and costs. Since Health Authorities make the final decision to approve or reject products, it is highly recommended to optimize authority communication and to hold face-to-face and teleconference meetings all along the development pathway. But how do you get the best out of your meeting with a Health Authority?
Authorities encourage to start discussions as early in the development process as possible so that developers can become aware of risks and weaknesses of their development plans to address them in a timely fashion. Meetings at critical milestones during development have been shown to dramatically increase the probability of timely approval.
PharmaLex has long-standing and extensive experience of interacting with the scientific committees and working parties of the EMA (e.g. CHMP, PRAC, COMP, PDCO, CAT) and with national Health Authorities. We frequently support our clients in Scientific Advice procedures at a national or central level, and in numerous health authority interactions throughout a product’s lifecycle (e.g. requests for PRIME eligibility, Orphan Medicinal Product designations, Pediatric Investigational Plans, Marketing Authorization Applications).
In the US, PharmaLex frequently engages with the FDA and has managed numerous of meetings with different FDA divisions for our clients (e.g. for pre-IND, End of Phase 2, pre-NDA or Type C meetings) or interacted with them in other drug development and authorization related procedures.
Similarly, PharmaLex supports interactions with other major Health Authorities worldwide, facilitated by our local country-based affiliates and partners who can provide local procedural guidance and logistical support.
As part of its regulatory service offering, PharmaLex has had extensive experience representing clients at FDA regulatory meetings and regulatory advice communications. We have worked with clients across all stages of development, from discussing IND readiness at pre-IND meetings, clarifying critical developmental questions at Type C meetings, and have assisted clients with halted development programs at Type A meetings as well as supporting later stage development at End of Phase 2 and pre-NDA meetings. PharmaLex has also assisted clients at Biosimilar Biological Product Development (BPD) meetings from Biosimilar initial advisory meeting (BIA) to BDP Type 1-4) to support biosimilar product development in the US.
PharmaLex’s expertise is not limited to specific divisions or indications, as we have interacted with nearly every division at the FDA, including specialized units such as the Division of Clinical Outcome Assessment (DCOA, formerly SEALD) and office of orphan product development (OOPD).
PharmaLex offers support during all aspects of the meeting process, from assisting with meeting strategy, through authorship, review, and submission of meeting related documents, Sponsor meeting preparation, FDA meeting attendance, and follow up activities. PharmaLex prides itself in understanding the goals of the client and identifying appropriate strategies for both effectively communicating with the FDA and fostering a collaborative relationship with the Agency, thereby resulting in efficient product development often saving Sponsors time and money.
- Proven track record
- Just in the last 5 years (2015-2020) supported 60+ FDA meetings, including pre-IND, End of Phase 1 and 2, Pre-NDA, Type C, Type A, and Biosimilar (BIA, BPD 1, 2 and 3) Meetings, ANDA controlled correspondence and Pre-ANDA meetings.
- Diverse experience portfolio
- Experience spans small and large (polymers) molecules, biologics including cell and gene therapies including regenerative medicine, recombinant proteins, biosimilars, and combination products
- Expertise working with multiple FDA review divisions across both CDER and CBER, supporting numerous indications at various stages of development
- Expertise in various therapeutic areas such as rare diseases, advanced therapies, acute and chronic pain, CNS disease, oncology, and gastrointestinal disorders providing a wide range of experience to support multiple different types of programs
- Ability to support all aspects of meeting preparation and related activities
- Substantial experience in assisting clients with FDA meeting strategy, formulating thoughtful meeting discussion topics, designed to maximize meeting opportunity, leading to efficient development programs
- Significant experience with authorship and submission of required meeting materials, including meeting requests and briefing documents, in compliance to FDA guidelines, to ensure FDA is well informed of the Sponsor’s program and developmental strategy to support meeting discussion
- Able to prepare and lead meeting rehearsals to certify all attendees are well prepared prior to meeting with the Agency, including assisting with overall messaging strategy to support the Sponsor’s goals of the meeting
- Ability to attend and/or lead FDA meetings on behalf of the Sponsor, assisting with the facilitation of the meeting discussion and fostering collaboration with the FDA
Aiding and steering of follow-up activities and interactions occurring from the FDA meeting including authorship and submission of meeting minutes and developing appropriate program strategy based on FDA meeting discussion.
Meetings with Health Authorities are highly valuable opportunities to consolidate and optimize your development strategy with the input of the future decision makers on your marketing authorization application. Opportunities for direct interactions with regulators are still limited though nowadays all major authorities offer regulatory and scientific advice meetings. To get the best out of them, they must be well prepared.
PharmaLex has extensive experience of leading clients through the Scientific Advice process. We frequently support centralized Scientific Advice process at the SAWP/CHMP or national Health Authorities. In addition, we support our clients interacting with all scientific committees and working parties of the EMA (e.g. CHMP, PRAC, COMP, PDCO, CAT).
We make you aware what Health Authorities pay attention to, what kind of inquiries they make and what they expect to hear from applicants.
- Proven track record (last five years)
- > 75 Scientific Advices
- > 25 Pediatric Investigational Plans (PIP)
- > 15 Orphan Medicinal Product (OMP) designations
5 Advanced Therapy Medicinal Product (ATMP) classifications
5 PRIME eligibility and Innovation Task Force (ITF) meetings
3 Adaptive Pathway eligibility applications - > 10 CP Pre-Submission and Rapporteur meetings
- Supporting all aspects of meeting preparation
- Advice: We help to decide on the strategy of approaching regulatory health authorities and which questions to ask.
- Documentation: We provide support to compile a briefing package including all necessary documentation.
- Coaching: We train your meeting delegates to ask the right questions and to obtain relevant answers.
- Meeting: We attend and/or lead the meeting with the Health Authority on behalf of the client facilitating the meeting discussion.
- Response: We use our regulatory expertise and experience to interpret health authority requests and recommendations.
- Implementation: We support project teams to adequately and timely address the advice received.
What our clients say
We needed a partner to help us obtain device approval. PharmaLex have not only helped us achieve this but are now providing on-going post-marketing surveillance support. We would highly recommend them to anyone who needs specialist expertise.
Med Device company, US
Senior Regulatory Affairs Director
Senior Regulatory Affairs Director
Hard working and there when you need them
Europe based large biotech
Regulatory Manager
Regulatory Manager