INGENES™ LLC helps pharmaceutical, biotechnology, medical device, and cosmetic companies avoid costly FDA setbacks — Refuse to File letters, Additional Information requests, Clinical Holds, and Warning Letters — with a clear, de-risked regulatory pathway to market.
IND, NDA, BLA regulatory packages, preclinical study design, CMC support and GMP compliance consulting.
510(k), PMA, De Novo submissions, DHF/DMR preparation, combination product strategies, ISO 13485 QMS.
BLA preparation, biosimilarity studies, immunogenicity assessments, CBER regulatory pathways.
NIH SBIR/STTR, BARDA, state and nonprofit grant application strategy and writing services.
If any of these are slowing down your program, INGENES™ can help you get back on track — with a clear, FDA-aligned strategy built around your specific submission.
Your NDA, BLA, or 510(k) was rejected before substantive review. We help you identify the gaps and rebuild a submission FDA will accept.
FDA has paused your clinical trial over safety, design, or data concerns. We help you respond, resolve the hold, and restart enrollment.
FDA issued an Additional Information request on your 510(k) or PMA. We help you craft a complete, well-supported response on the first try.
An FDA inspection flagged quality system or GMP gaps. We help you build a CAPA and remediation plan that satisfies FDA and protects your timeline.
Your NDA or BLA received a CRL. We help you analyze FDA's concerns and build a resubmission strategy aimed at approval.
Not sure when or how to request a Pre-Sub or Type B meeting? We help you plan the right FDA interaction at the right time.
510(k), De Novo, PMA, IND, NDA, ANDA, 505(b)(2), or BLA — not sure which applies to you? We map the fastest, lowest-risk pathway for your product.
Worried your quality system won't hold up to an FDA inspection? We run gap assessments against 21 CFR 820 and ISO 13485 before FDA does.
From early-stage discovery through post-market surveillance, INGENES™ provides integrated regulatory strategy, quality management, and contract research services tailored to your pipeline.
IND/NDA/ANDA filing, preclinical safety packages, GLP toxicology, ADME, bioanalytical services, and regulatory strategy.
BLA preparation, biosimilarity studies, immunogenicity, cell and gene therapy regulatory pathways, CBER submissions.
510(k), PMA, De Novo, DHF/DMR, ISO 13485 QMS, combination products, design controls, and post-market surveillance.
Safety assessments, labeling compliance, FDA/EU regulatory strategy, ingredient safety dossiers, and MoCRA compliance.
RFD filings, primary mode of action analysis, and integrated CDER/CBER/CDRH regulatory strategy for drug-device and biologic-device products.
End-to-end support across all stages — from target identification through regulatory submission and post-market compliance.
Target ID, lead optimization, in vitro biology, ADME screening, medicinal chemistry, hit-to-lead programs.
GLP toxicology, safety pharmacology, pharmacokinetics, dose range finding, IND-enabling study packages.
IND/CTA preparation, clinical trial monitoring, bioanalytical support, PK/PD modeling, regulatory affairs.
Complete regulatory dossier, CTD/eCTD format, non-clinical for NDA/BLA, pre-submission FDA meetings.
INGENES™ combines deep regulatory science expertise with hands-on project management. Our multidisciplinary team of PhDs, regulatory specialists, and industry veterans deliver accelerated timelines and FDA-aligned quality.
IND, NDA, BLA, 510(k), PMA — full submission lifecycle management.
ISO 13485, 21 CFR Part 11, GMP/GLP/GCP compliance and audit readiness.
Contract manufacturing oversight, CRO selection and performance management.
NIH, BARDA, state and nonprofit grant applications with high success rates.
Before you submit to FDA, make sure you've covered the basics. Our free checklist walks you through the critical regulatory, quality, and documentation requirements that most commonly trigger Refuse to File letters, AI requests, and review delays — across IND/NDA, 510(k)/PMA, BLA, and cosmetics submissions.
12-page PDF · Updated for 2026 FDA guidance · Free instant download
Talk to a regulatory strategist about your product, your timeline, and the fastest compliant path to FDA clearance or approval — no cost, no obligation.
A trusted partner in life sciences regulatory consulting, contract research, and quality management — advancing your pipeline from discovery to approval.
INGENES™ LLC was founded by a multidisciplinary team of regulatory scientists, pharmacologists, and quality assurance experts with decades of combined experience navigating the complex landscape of FDA regulatory submissions and life sciences product development.
We serve innovators across pharmaceutical, biotechnology, medical device, and cosmetics sectors — from emerging startups to established multinationals — providing the expertise and strategic guidance needed to bring safe, effective products to market efficiently. Based in Rockville, Maryland, we are strategically positioned near FDA headquarters and NIH.
Every recommendation is grounded in evidence-based science and current regulatory expectations.
We function as an extension of your team, aligning our expertise with your organizational goals.
Transparent, compliant, and ethical guidance at every stage of product development.
Responsive, timeline-driven project management for fast-moving drug and device programs.
"Science without strategy is just data. Strategy without science is just guesswork. INGENES brings both."
Former FDA reviewers and senior regulatory professionals with expertise across all major submission types and product categories.
PhD toxicologists, pharmacologists, and study directors with GLP-compliant research experience across multiple species and routes.
QA/QC specialists certified in ISO 13485, 21 CFR Part 820, and pharmaceutical GMP with audit and inspection readiness expertise.
PMP-certified program managers ensuring timelines, budgets, and deliverables are met for complex regulatory programs.
Facing an IND clinical hold, a CRL, or uncertainty over IND vs. NDA vs. 505(b)(2)? INGENES™ provides regulatory, preclinical, and CMC services that keep small molecule and biologic programs moving — from IND-enabling studies through NDA/BLA filing.
INGENES™ provides full project management of IND-enabling preclinical programs including GLP-compliant toxicology studies in rodent and non-rodent species, genotoxicity assessments, safety pharmacology panels (cardiovascular, respiratory, CNS), and DART studies. We coordinate with qualified CROs to deliver complete IND packages satisfying 21 CFR Part 312 requirements.
We identify, qualify, and manage CDMOs and CROs on your behalf — ensuring GMP/GLP compliance, study integrity, and on-time delivery. Vendor oversight services cover audits, technical due diligence, and ongoing performance management.
For end-to-end formulation development, GMP analytical testing, ICH stability studies, and cGMP contract manufacturing, INGENES™ partners with INGENESIS® — a dedicated pharmaceutical CDMO delivering integrated development and manufacturing from pre-formulation through commercial-scale production.
For dedicated CDMO/CRO formulation development and cGMP manufacturing, visit our partner: INGENESIS® — Pharmaceutical CDMO Services ↗
Navigating CBER review timelines, an immunogenicity question, or a biosimilarity gap? INGENES™ provides specialized regulatory and development consulting for monoclonal antibodies, vaccines, gene therapies, cell therapies, and biosimilars.
Biologics CMC is among the most complex regulatory domains. INGENES™ provides expert guidance on manufacturing process characterization, analytical method validation, container closure integrity, formulation development, and cell banking strategies — aligned with ICH Q5A–Q5E, Q6B, and ICH Q11 guidelines.
As cell and gene therapies rapidly evolve, INGENES™ provides regulatory strategies tailored to these novel modalities, including Phase I/II IND preparation, FDA pre-IND meeting support, RMAT designation applications, and risk-based CMC strategies for autologous and allogeneic platforms.
Got a 510(k) AI letter, a Not Substantially Equivalent (NSE) decision, or an inspection-readiness gap? INGENES™ provides end-to-end regulatory consulting for FDA Class I, II, and III devices — from concept through 510(k), PMA, De Novo, and combination products.
For deep-dive 510(k), PMA, De Novo, and device Quality Management System (ISO 13485 / 21 CFR 820) engagements, INGENES™ partners with MEDEVICE™ — a firm dedicated exclusively to medical device and combination product regulatory consulting.
INGENES™ implements FDA QSR (21 CFR Part 820) and ISO 13485:2016-compliant quality management systems. Services include QMS gap assessments, SOP development, CAPA systems, complaint handling, internal audit programs, and FDA inspection readiness preparation. For dedicated device QMS build-outs and remediation, see our MEDEVICE™ partner page → — or explore our own Quality Management System services →.
We develop and maintain complete DHF documentation packages including design inputs/outputs, design verification and validation (V&V), design transfer, and design reviews — all traceable through a design history supporting 510(k) and PMA technical files.
Developing a drug-device combination product? See our dedicated Combination Products page → for RFD filings, primary mode of action analysis, and integrated CDER/CDRH regulatory strategy.
For specialized 510(k)/PMA submissions and device-specific QMS support, visit our partner: MEDEVICE™ — Medical Device & Regulatory Consulting ↗
Bridging FDA's CDER, CBER, and CDRH centers is one of the most complex regulatory challenges in life sciences. INGENES™ provides integrated combination product regulatory strategy — from classification and Request for Designation through coordinated drug and device submissions.
Determining which FDA center has primary jurisdiction over your combination product — and which center provides consult review — shapes your entire regulatory strategy. INGENES™ helps you analyze your product's primary mode of action, prepare a Request for Designation when classification is unclear, and navigate FDA's intercenter agreements.
A combination product submission must satisfy the regulatory requirements of each constituent part while presenting a single, coherent regulatory story to FDA. INGENES™ coordinates drug, biologic, and device regulatory workstreams — aligning CMC, device design controls, risk management, and clinical data into one integrated submission package.
Combination products require a quality system that satisfies both drug cGMP (21 CFR Parts 210/211) and device QSR/QMSR (21 CFR Part 820) requirements under 21 CFR Part 4. INGENES™ helps manufacturers design quality systems that meet both sets of requirements without duplicative, conflicting documentation.
Looking for standalone device 510(k)/PMA or QMS support? See our Medical Devices page → or our Quality Management Systems page →.
For specialized device constituent part support on combination products, visit our partner: MEDEVICE™ — Medical Device & Regulatory Consulting ↗
Behind on MoCRA facility registration, unsure if your product is a cosmetic or an OTC drug, or facing an FDA adverse event reporting question? INGENES™ provides FDA regulatory compliance, safety assessment, and labeling consulting for cosmetics and personal care products.
The Modernization of Cosmetics Regulation Act of 2022 significantly expanded FDA's authority over cosmetics. INGENES™ guides cosmetic companies through mandatory facility registration, product listing, Good Manufacturing Practice (GMP) compliance, serious adverse event reporting, and safety substantiation requirements.
Our safety assessment services include toxicological risk assessment of individual ingredients and finished formulations, assessment of dermal absorption, sensitization potential, mutagenicity, and reproductive toxicity — supporting both domestic and international market compliance.
Worried your QMS won't survive an FDA inspection, or starting from scratch and don't know where to begin? INGENES™ designs, implements, and remediates quality management systems aligned to 21 CFR Parts 210/211, 21 CFR Part 820 (QSR/QMSR), and ISO 13485:2016 — for pharmaceutical, biologic, device, and combination product manufacturers.
An FDA Form 483 or Warning Letter is urgent — and how you respond shapes the agency's view of your entire quality culture. INGENES™ helps you investigate root cause, draft a defensible CAPA plan, implement corrective actions, and prepare the written response FDA expects within 15 business days.
For startups and early-stage companies, we build a right-sized QMS scoped to your product, stage of development, and regulatory pathway — avoiding the trap of either an under-built system that fails inspection or an over-engineered system that slows you down.
FDA's Quality Management System Regulation (QMSR) now incorporates ISO 13485:2016 by reference. INGENES™ helps device manufacturers harmonize their existing ISO 13485 QMS with QMSR requirements, update documentation, and prepare for the transition with minimal disruption to operations.
For full-scope ISO 13485 / QMSR quality system builds, DHF remediation, and mock FDA inspections specific to medical devices and combination products, INGENES™ partners with MEDEVICE™ — a firm dedicated exclusively to medical device and pharmaceutical regulatory consulting.
For pharmaceutical cGMP quality systems tied to contract manufacturing — 21 CFR Parts 210/211, ICH Q10, and batch release — INGENES™ partners with INGENESIS®, a pharmaceutical CDMO with integrated quality systems supporting clinical and commercial manufacturing.
Regulatory guidance documents, white papers, and case studies to support your life sciences development programs. Access expert insights from the INGENES™ team.
A 12-page checklist covering the documentation, quality system, and pre-submission requirements that most often trigger Refuse to File letters, AI requests, and review delays.
A comprehensive walkthrough of the 510(k) premarket notification process, from predicate device selection through clearance — including common deficiency responses and FDA communication strategies.
Download PDFHow INGENES™ coordinated a multi-CRO GLP toxicology program and delivered a complete IND package within 14 months for a Phase I oncology study targeting solid tumors.
Read Case StudyAn in-depth analysis of the Modernization of Cosmetics Regulation Act and its implications for facility registration, product listing, GMP, and adverse event reporting obligations.
Read White PaperKey regulatory and scientific considerations for developing a successful biosimilar program, including totality-of-evidence approach, analytical similarity, and FDA/EMA regulatory differences.
Download GuideA 12-month QMS implementation project that prepared a startup medical device company for CE marking and FDA registration, including design controls and risk management.
Read Case StudyStrategies for securing NIH SBIR/STTR Phase I and Phase II funding, including specific aims structure, significance assessment, and innovation narrative development.
Read White PaperTell us about your product and your biggest FDA challenge. A regulatory strategist will review your situation and respond with a clear path forward — free, and with no obligation.
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