U.S. FDA Regulatory Science · Medical Technologies · Regulatory Strategy
The regulatory strategy your device deserves — built by scientists who know exactly how FDA reviews it.
Tacticity Advisors is an India-based regulatory science practice helping medical device, IVD, and SaMD companies navigate U.S. FDA — with strategies grounded in technical evidence, product risk, and direct knowledge of how FDA reviewers evaluate submissions.
Founded by a former FDA scientist
Tacticity was founded by a former U.S. FDA CDRH scientist and lead reviewer — someone who spent years on the other side of the table, evaluating how evidence is assembled, how risk-benefit arguments hold up under scientific scrutiny, and what separates a submission that clears from one that stalls. Based in Pune, India, Tacticity brings that firsthand U.S. FDA perspective directly to the Indian and global medtech ecosystem — where it is needed most. Every recommendation we make is grounded in that direct experience: we understand not just what U.S. FDA requires, but why each requirement exists and how a reviewer will interpret the evidence you provide.
- Medical Devices · IVD · SaMD
- 510(k) · De Novo · PMA · Q-Submissions
- Biocompatibility · ISO 10993
- Chemical Characterization · E&L
- Performance Testing Strategy
- CRO Test Protocol & Report Review
- Assessing Data Integrity
- FDA Deficiency Response
Regulatory strategy shaped by science and FDA review experience.
We support medical technology companies across U.S. FDA pathway strategy, evidence planning, submission preparation, and review response — from first concept through post-market compliance.
Who We Work With
Indian MedTech Companies
Indian manufacturers and startups seeking U.S. FDA clearance or approval — including 510(k), De Novo, and PMA — who need a regulatory partner with direct FDA experience.
International Companies
Global medical device companies — including U.S., European, and APAC manufacturers — seeking support with U.S. FDA submissions, testing strategy, and CRO coordination for India-based studies.
CROs & Testing Laboratories
Contract research organisations and testing labs in India seeking scientific protocol design, regulatory alignment review, and expert guidance on what FDA actually requires from their studies.
Startups & Deep-Tech Ventures
Early-stage medical technology companies — including those in deep-tech incubators and innovation programs — building their regulatory strategy from the ground up, often for the first time.
Principle 01
Define the right regulatory question before generating the evidence.
Principle 02
Match evidence to risk — not to convention or volume.
Principle 03
Anticipate the reviewer's lens at every stage of the program.
Principle 04
Present the case as a technical argument that withstands expert review.
Because FDA review is not just document review.
Tacticity helps companies define the right questions early, generate the right evidence, and present the case clearly.
The strength of a submission is determined by how clearly the evidence answers the relevant risk questions — not by its volume.
We explain the science, not just the requirement.
Most regulatory consultants tell you what FDA needs. We tell you why — and what it means for your specific device, your data, and your timeline.
01
You will always know how your file will be read
We have reviewed submissions like yours from inside FDA. We know what a reviewer looks for first, where arguments typically break down, and how scientific gaps become deficiency letters. That knowledge is applied to your program from day one — so there are no surprises after you submit.
02
Every requirement comes with a rationale
We do not ask you to run a test or produce a document without explaining what scientific question it answers and why FDA expects it. You will understand the logic behind each element of your regulatory strategy — which means better decisions, fewer unnecessary studies, and a team that is genuinely prepared for the questions that follow.
03
Science-led, not process-led
Strong scientific rationale is not just good practice — it is the most practical tool a device company has. When the underlying science is sound and clearly reasoned, regulators ask fewer questions, additional information requests are avoided, and testing can be scoped to exactly what the submission requires. We help you identify which studies are genuinely necessary and build the scientific case that makes each one count.
04
Honest assessment at every stage
If your evidence has gaps, we identify them early and explain precisely what it would take to address them. Our value is in the accuracy of the assessment — not in telling you what you want to hear.
FDA regulatory support, from first submission to full lifecycle management.
Every engagement is defined by the technology, the regulatory stage, and what the program actually needs. We work across the full device development lifecycle — from early pathway strategy through post-market compliance — and across all major device categories, including implantables, IVDs, SaMD, and combination products. Whether the need is targeted and specific or end-to-end, the depth of engagement is the same.
Regulatory Strategy & Pathway
From first classification decision to submission-ready plan
- FDA pathway strategy and submission planning
- Device classification, product code assessment, and 510(k) exemption analysis
- Combination product determination and RFD support
- Applicable consensus standards identification and Declaration of Conformity
- Predicate search, intended use alignment, and substantial equivalence narrative
- Breakthrough Device Designation — request preparation and FDA engagement
- 513(g) — Request for Classification Information
FDA Premarket Submissions
Full preparation and support for every premarket pathway
- 510(k) — Traditional, Abbreviated, and Special
- PMA — Premarket Approval Application and supplements
- De Novo — Classification request preparation
- Q-Sub / Pre-Sub — written feedback and meeting requests
- IDE — Investigational Device Exemption
- Change assessment memos — determining whether a modification triggers a new submission
Biocompatibility & Materials Evaluation
Risk-based biological safety grounded in materials science
- ISO 10993 strategy and biological evaluation planning
- Biological evaluation plans (BEP) and reports (BER)
- Chemical characterization — systematic identification and quantification of chemical substances released from device materials, including extractables and leachables
- Toxicological risk assessment and materials justification
- CRO protocol scientific review and study design alignment
- Report adequacy review before submission
Testing Strategy & Evidence Planning
Designing the evidence before committing the budget
- Testing matrix recommendation and gap analysis
- Performance test design aligned with FDA-recognized standards
- Sterilization, shelf-life, packaging, and usability testing strategy
- CRO engagement support and report adequacy review
- Labeling review — FDA requirements, UDI compliance (21 CFR Part 830), and IFU review
- Applicable consensus standards mapping and Declaration of Conformity
Quality System & Compliance
Regulatory obligations beyond the submission
- FDA QSR (21 CFR Part 820) / ISO 13485 gap assessment
- Design controls review and documentation support
- Establishment registration and device listing (21 CFR Part 807)
- UDI system compliance review
- Post-market surveillance plan development
- Post-approval study (PAS) design for PMA holders
- MDR (Medical Device Reporting) advisory — reportability determinations and 21 CFR Part 803 obligations
FDA Enforcement Response & Remediation
Strategic and scientific support when FDA has questions
- FDA deficiency and Additional Information (AI) response strategy
- Warning Letter response — root cause analysis, CAPA, and response drafting
- FDA Form 483 response — observation-by-observation strategy
- Recall strategy, classification planning, and FDA coordination
- Field Safety Corrective Action (FSCA) planning and documentation
- Consent Decree advisory and Import Alert response strategy
- Lifecycle management — modifications, line extensions, and new indications
From early development to FDA response.
Stage 01
Early Strategy
Pathway, intended use, claims, classification, predicate landscape, and early evidence planning.
Stage 02
Pre-Testing
Protocol design, test selection, sample justification, CRO review, and standards alignment.
Stage 03
Submission
510(k), De Novo, PMA, Q-Sub, eSTAR, technical documentation, and scientific narrative.
Stage 04
Post-Submission
Additional Information responses, deficiency remediation, FDA communication, and evidence gap closure.
Tanmay Jain, PhD
Founder & Principal
Former U.S. FDA CDRH Scientist & Lead Reviewer
Polymer Scientist
Founded by a scientist who has reviewed from the FDA side.
Tacticity Advisors was founded by Tanmay Jain, PhD, a polymer scientist and former U.S. FDA CDRH scientist and lead reviewer, now based in Pune, India.
His work at U.S. FDA's Center for Devices and Radiological Health included scientific review of premarket submissions, regulatory science research, materials evaluation, biocompatibility, chemical characterization, performance testing, and standards-related work — including development of ASTM F3718.
After years at FDA, Tanmay returned to India with a deliberate purpose: to bring the scientific rigour and regulatory depth of the U.S. FDA review process directly to the Indian medtech ecosystem — an industry with immense promise that deserves access to the same quality of regulatory expertise as companies in the U.S. and Europe. Tacticity was built to close that gap.
That dual background — deep scientific training in polymer materials and direct experience evaluating how U.S. FDA interprets evidence — shapes how Tacticity works: regulatory strategy is not paperwork. It is a structured technical argument that must withstand expert review.
Beyond client work, Tanmay has delivered lectures and workshops at Venture Center Pune, IIT Bombay SINE, IIT Mandi Catalyst, and several medical device companies — helping engineers, product teams, and entrepreneurs understand U.S. FDA regulatory requirements and the science behind them. These engagements reflect a broader commitment to building regulatory literacy across the Indian medtech ecosystem.
Engage
Know what FDA is looking for — before you submit.
Whether you are an Indian company pursuing U.S. FDA clearance, a global manufacturer managing an India-based regulatory program, or a CRO seeking expert scientific alignment — we help you build a U.S. FDA regulatory strategy grounded in evidence, scientific logic, and direct reviewer experience.
Contact Tacticity Advisors