FDA Consulting - INGENES

Medical devices continue to play a vital role in the advancement of modern medicine - from neurostimulators and joint replacements to implantable defibrillators, stents, coils and screws - medical devices are everywhere, constantly evolving to incorporate new technologies and always adapting to ever-changing standards of care.

The Medical Device development and regulatory approval processes are both complex and highly nuanced. Ingenes Regulatory Service consulting is a medical device consulting firm with extensive experience in providing regulatory, product development and quality systems consulting services to manufacturers of medical device products.

Our team of consultants is comprised of former FDA reviewers, managers or high level officials, all with extensive experience in every aspect of the medical device regulatory and product development process, from nonclinical testing and verification through manufacturing, design and evaluation of clinical trials to commercialization. This includes expertise in each of the following elements of the product development process: pharmacology/toxicology, software, quality management, product manufacturing, medical device biocompatibility, clinical trial design and evaluation, immunogenicity assessment, statistics, GTP, GMP, GLP and GCP regulatory compliance, and U.S. Agent Services.

Our team’s knowledge and hands-on experience with successful PMAs, 510(k)s, HDEs, pre-Subs, IDEs, 513gs and other submissions spans the full spectrum of medical device product development pathways. We are intimately aware of the intricacies associated with each pathway – expertise that positions our clients for the most successful outcome possible.

Ingenes Regulatory Service consulting offers more than consulting services and regulatory support to its clients. Our team provides a full complement of medical device development consulting services to support your product development process. Ingenes Regulatory Service consulting’s expertise extends from medical device design, verification and validation testing through clinical trial design, oversight and submission preparation, and FDA support services. In each client engagement, we view ourselves as a success partner and a member of the medical device development team.

Our mission is to provide guidance and value at every step of the device product development process, from concept to clinical trials to commercialization. Regardless of the current stage of your product development, the Ingenes Regulatory Service consulting team brings the scientific knowledge, regulatory know-how and industry experience necessary to step in and provide hands-on assistance to your team.

Our experts will collaborate with your team to assess your product development plan, define all applicable scientific and regulatory requirements, and craft a customized product development and testing strategy that minimizes cost and time to clinical trials, regulatory approval and commercialization. Whether your proposed device is an improvement on an existing product or a revolutionary breakthrough requiring a full PMA submission, our team brings decades of FDA and product development experience.

Ingenes Regulatory Service consulting team will work with your team to identify the appropriate pathway for approval, whether it be a 510(k) submission, HDE application, de novo petition, or PMA. Once a plan of action has been established, Ingenes Regulatory Service consulting will be with you every step of the way to manage preliminary documentation and testing, provide hands-on leadership at meetings with the FDA and support your regulatory submission with advice to ensure the best possible submission. Our goal is to craft a document that meets the FDA’s expectations, leading to an efficient and timely review process.

Once your IDE application has been submitted (if your device type requires an IDE), we will support your product development team with advice during the IDE review and approval process. Our consultants leverage their unique “insider” perspective to interpret Agency requests as well as to provide guidance on the latest Agency thinking, giving you the best chance for a successful outcome while eliminating the guesswork and costly delays that plague many Agency interactions.

Once an IDE approval has been secured, the Ingenes Regulatory Service consulting team supports your clinical trial efforts with clinical consulting services tailor-made to your product. From organizing trials to analyzing data generated and auditing returns, the Ingenes Regulatory Service consulting team brings the scientific knowledge and proven industry experience necessary to ensure your trials are effective and efficient. We also know how to translate clinical trial results into compelling stories that resonate with the FDA, NIH and RAC – putting your product in the best possible position for rapid approval and delivery to market.

In addition to our expertise in nonclinical testing, clinical trial design and FDA submission support services, Ingenes Regulatory Service consulting employs a team of experts in all aspects of testing, manufacturing, storage, and distribution, so you can rest assured that all aspects of your operation are fully compliant with FDA regulations and 21 CFR 820 requirements.

Our team is well positioned to assist your organization in preparing and submitting your application. During the submission preparation process, we provide hands-on support and guidance in interpreting CDRH, CDER and CBER interactions. Our team can help translate raw nonclinical and clinical data into a compelling story that will resonate with FDA reviewers, and lead to the best possible outcomes for your medical device application.

Once your device application has been approved and your product is ready to go to market, the Ingenes Regulatory Service consulting team is able to provide assistance in overseeing manufacturing and quality control, drafting requested periodic updates for the FDA (if required) and assisting your team through additional development and commercialization processes.

Ingenes Regulatory Service consulting team has extensive experience in providing regulatory, product development and quality systems consulting services to developers and manufacturers of pharmaceutical products.

Our team of pharmaceutical consultants brings decades of experience at every stage of the pharmaceutical regulatory and product development process, from nonclinical testing and verification through manufacturing, design and evaluation of clinical trials to commercialization. This includes expertise in each of the following elements of the product development process: pharmacology/toxicology, quality management, product manufacturing, medical device biocompatibility, clinical trial design and evaluation, statistics, GMP, GLP and GCP regulatory compliance, and U.S. Agent Services. For each engagement, we leverage our knowledge and hands-on experience in creating product development pathways and maneuvering through the relevant nuances to position our clients for successful outcomes and regulatory approvals.

Ingenes Regulatory Service consulting is proud to offer more than consulting services and regulatory support to our clients – once we are on-board, we view ourselves as your success partner. Our mission is to provide guidance and value at every step of the drug development process, from conception to clinical trials to commercialization. Regardless of the stage of your product’s development, the Ingenes FDA Regulatory Service consulting team brings the scientific knowledge and industry experience necessary to step in and provide hands-on support to your team.

Ingenes Regulatory Service consulting 's pharmaceutical consultants will collaborate with your team to assess your product development plan, identify the appropriate pathway for approval, define all applicable regulatory requirements and craft a customized product development strategy that minimizes time to clinical trials and regulatory approval.

Ingenes Regulatory Service consulting will collaborate with your product development team to manage preliminary testing, request, prepare for and attend meetings with the FDA and other key stakeholders, as well as assist with pre-IND and IND consulting for your new product.

Once your IND application has been submitted to the FDA, Ingenes Regulatory Service consulting will support your product development team with advice every step of the way through the IND review process. Our consultants leverage their unique "insider" perspective to interpret Agency requests and communications as well as provide guidance on the latest FDA thinking, thereby positioning your new product for successful outcomes.

Once an IND is allowed to proceed, the clinical stage of development begins. During this stage, the Ingenes Regulatory Service consulting team supports your clinical trial efforts with quality/CMC and clinical consulting services customized to your product. From designing Phase 1 protocols, to the oversight of clinical trials conducted by CROs, to a "FDA-type" review of data generated by Phase 3 studies, our clinical trials oversight group brings scientific insights, medical and clinical operations knowledge and industry experience necessary to ensure your trials are successful and part of an efficient overall regulatory strategy.

In addition to our expertise in nonclinical, clinical and quality/CMC consulting, Ingenes Regulatory Service consulting got a team of expert consultants in product manufacturing and testing requirements for all classes of pharmaceuticals - knowledge that we leverage to bolster your chances of a successful ANDA or NDA application regardless of the development pathway. The Ingenes Regulatory Service consulting team, together with your product team, will ensure that all aspects of testing, manufacturing, storage, and distribution are fully compliant with constantly evolving FDA regulations.

With multiple submissions to FDA in the past three years, the Ingenes Regulatory Service consulting team is well positioned to assist your organization in preparing and submitting your marketing application, regardless of pathway. During the application process, we provide hands-on support, preparation for Agency meetings and guidance in interpreting feedback from CDRH, CDER and CBER. Our team can help translate raw clinical data into a compelling story that will resonate with FDA reviewers, evaluate labeling options and review marketing collateral to ensure accuracy, compliance and the best possible outcome for your product's application.

Once your product marketing application has been approved and your product is ready to go to market, the Ingenes Regulatory Service consulting team is able to provide assistance in overseeing manufacturing and quality control, drafting required periodic safety updates for the FDA, and assisting your team throughout the product lifecycle and commercialization processes, including re-positioning the FDA application for international regulatory approvals.

Unlike a traditional, stand-alone biologic, the development of a biosimilar product presents a distinctly different set of nonclinical, clinical and regulatory expectations as well as substantial scientific and manufacturing challenges. The goal of the biosimilar application is to provide a comprehensive demonstration of biosimilarity in addition to overall safety and efficacy of the product.

Our mission is to provide counsel and critical insights into FDA thinking throughout the biosimilar product development lifecycle, from concept to clinical trials to commercialization. At every stage of the process, you’ll have the confidence of knowing that an industry thought leader in the development and production of biosimilar products is at your side, providing the focused guidance and counsel necessary to position your new product for success.

Our team brings decades of experience at every stage of the biologic regulatory and product development process, from nonclinical testing and verification through manufacturing, design and evaluation of clinical trials to commercialization. This includes expertise in each of the following elements of the product development process: pharmacology/toxicology, quality management, product manufacturing, clinical trial design and evaluation, statistics, GMP, GLP and GCP regulatory compliance.

Our regulatory consultant will collaborate with your team to assess your biosimilar development plan, define all applicable scientific and regulatory requirements, and craft a customized product development strategy that minimizes cost and time to clinical trials, regulatory approval and commercialization.

At the core of any successful biosimilar application (i.e. a 351(k) BLA) is a demonstration of comparability with a reference product. This starts with a comprehensive structural and functional characterization of the proposed product. Our team of world-renowned scientists and former FDA reviewers bring an insider perspective into the latest in Agency thinking – allowing your team to focus on gathering and presenting the scientific data regulators want to see. Our regulatory team can assist your product development team in every aspect of the characterization and analysis process, from understanding the molecule and its function to assessing variability and quality between your proposed product and a reference biologic.

For a successful biosimilar, one must be able to demonstrate comprehensive analytical similarity, from molecular structure and stability through receptor binding and functional activities. Our team can help to design, monitor, interpret and audit the analytical testing process, ensuring that your development plan remains on-track and scientifically valid. Our extensive research & development and product evaluation expertise allows us to recommend strategies that minimize a product’s time to market and maximize the breadth of patient access.

Following a successful demonstration of structural and functional similarity, it is necessary to demonstrate the safety and equivalent efficacy of the proposed biosimilar in a nonclinical setting through the use of animal toxicity studies, PK/PD studies and other testing as necessary. Our Pharmacology/Toxicology team brings an unparalleled level of expertise to this phase of the biosimilar product development process, helping your team to address any residual uncertainties which may be generated during Phase 1 and Phase 2 clinical studies. As former FDA officials and industry leaders, we understand what FDA’s Pharm/Tox reviewers will be expecting from a successful application and we can provide guidance on which approaches, studies and tests will best alleviate the Agency’s concerns while minimizing development costs and time to market. We pride ourselves on understanding the factors involved in the FDA decision-making process at every stage of the product development process and leverage that expertise to position our clients for successful outcomes.

Ingenes Regulatory Services Consulting team consist of clinical experts with regulatory, clinical trial, and clinical operations experience in designing, planning, monitoring, interpreting, and auditing clinical trials for bioequivalence. Our experts will help you design and manage clinical trial program that demonstrates safety, PK/PD, immunogenicity, and efficacy similarity between your product and its reference product.

In addition to assisting clients through the design and implementation of their clinical trial, Ingenes Regulatory Services also provides assistance in properly framing the data gathered and developing justifications for any results that deviate from accepted inferiority and superiority margins.

One of the goals of any biosimilar product development plan is to receive approval for the greatest number of possible conditions with the minimum amount of testing and trials, while ensuring product safety, efficacy and stability. Throughout your product development process, we focus on helping our collaborators & partners to design processes that gather the molecular, nonclinical and clinical data necessary to justify extrapolation to other clinical indications, thereby maximizing your market opportunity while lowering development costs.

The Biologic product development framework is replete with regulatory complexity and nuance as well as substantial scientific and manufacturing challenges unseen in traditional Pharmaceutical product development. Ingenes Regulatory Service consulting has extensive experience in providing successful advice on regulatory, product development and quality systems, to manufacturers of biologic products.

Our team brings decades of experience at every stage of the biologic regulatory and product development process, from nonclinical testing and verification through manufacturing, design and evaluation of clinical trials to commercialization. This includes expertise in each of the following elements of the product development process: pharmacology/toxicology, quality management, product manufacturing, medical device biocompatibility, clinical trial design and evaluation, immunogenicity assessment, statistics, GTP, GMP, GLP and GCP regulatory compliance, and U.S. Agent Services. Our knowledge and hands-on experience in hundreds of successful applications and regulatory submissions, including BLAs, 510(k)s and INDs spans the full spectrum of biologic product development pathways. Our breadth of experience allows us to develop comprehensive strategies and product development plans to position clients for successful product outcomes and regulatory approvals. Ingenes Regulatory Service Consulting is proud to offer more than consulting services and regulatory support to our clients by providing a full scope of biotech product development consulting services. Our expertise extends from product development and manufacturing to GLP consulting and GMP consulting, clinical trial management and BLA submission support services. In short, we are your success partner at every point in the product development continuum for your biologic product.

Our mission is to provide guidance and value at every step of the biologic product development process, from conception to clinical trials to commercialization. Regardless of the current stage of your product development, the Ingenes Regulatory Service Consulting team brings the scientific knowledge and industry experience necessary to step in and provide hands-on assistance to your team.

Ingenes Regulatory Service Consulting has extensive experience in providing regulatory, product development and quality systems consulting services to developers and manufacturers of pharmaceutical products.

Our team of consultants brings decades of experience in quality management, regulatory affairs, product manufacturing and testing, pharmacology/toxicology, clinical trial design and implementation, statistics, and GMP, GLP and GCP compliance. For each engagement, we leverage our knowledge and hands-on experience in creating product development pathways and maneuvering through the relevant nuances to position our clients for successful outcomes and regulatory approvals.

Ingenes Regulatory Service Consultants will collaborate with your team to assess your product development plan, identify the appropriate pathway for approval, define all applicable scientific and regulatory requirements, and craft a customized product development strategy that minimizes cost and time to clinical trials, regulatory approval and commercialization.

Ingenes Regulatory Service consultants will work with your team to manage preliminary testing, provide hands-on leadership at meetings with the FDA, OBA, RAC advisory committees as well as support your regulatory submission with pre-IND and IND consulting to ensure the best possible submission.

Once your IND application has been submitted to the FDA, Ingenes Regulatory service consultants will provide your product development team with advice every step of the way during the IND review process. Our consultants leverage their unique “insider” perspective to interpret Agency requests and communications as well as to provide guidance on the latest Agency thinking, positioning your new product for a successful outcome. Our team prides itself on quickly and accurately interpreting Agency requests and comments, eliminating the guesswork and costly delays that plague many Agency interactions.

Once an IND is allowed to proceed, the clinical stage of development begins. During this stage, the Ingenes Regulatory Service consulting team supports your clinical trial efforts with quality/CMC and clinical consulting services customized to your product. From designing Phase 1 protocols to the oversight of clinical trials conducted by CROs, to a “FDA-type” review of data generated by Phase 3 studies, our clinical team brings scientific insights, medical and clinical operations knowledge and industry experience necessary to ensure your trials are successful and part of an efficient overall regulatory strategy.

In addition to our expertise in nonclinical, clinical and quality/CMC consulting, Ingenes Regulatory Service Consulting also has a team of experts in product manufacturing and testing requirements for biologics – knowledge that we leverage to boost your chances of a successful BLA application. Successful applications that require GLPs and GMPs are strictly adhered to throughout every step of the application process to ensure every sample is substantially equivalent, safe and effective. The Ingenes Regulatory Service Consulting team brings decades of experience in all aspects of testing, manufacturing, storage, and distribution, so you can rest assured that all aspects of your operation are fully compliant with FDA regulations.

With multiple regulatory submissions to FDA in the past three years, the Ingenes Regulatory Service Consulting team is well positioned to assist your organization in preparing and submitting your BLA. During the application process, we provide hands-on support, leadership at Agency meetings and guidance in interpreting CBER, CDER and CDRH interactions. Our team can help translate raw clinical data into a compelling story that will resonate with FDA reviewers, evaluate labeling options and review marketing collateral to ensure accuracy, compliance and the best possible outcomes for your submission.

Once your product has been licensed and is ready to go to market, the Ingenes Regulatory Service consulting team is able to provide assistance in overseeing manufacturing and quality control, drafting required periodic safety updates for the FDA and assisting your team through additional development and commercialization processes, including re-positioning the FDA application for international regulatory approvals.