Analytical & Regulatory Science Consultancy
Compliance is a conclusion.
We provide the evidence and support global regulatory submissions.
Bhairvision Private Limited partners with qualified analytical laboratories and specialist institutes to deliver scientific insight and regulatory confidence across industries. With deep regulatory expertise, we support the full arc of a submission, from DMF compilation through lifecycle management, helping build dossiers that are scientifically defensible and ready for regulators.
From complex analytical questions to defensible scientific and regulatory decisions, Bhairvision Private Limited turns chemistry into evidence, and evidence into regulatory readiness, across six industries and major global regulatory markets.
Where we work
Our positioning — origin to destination
Who We Are
Decades of leadership. One scientific standard.
Bhairvision Private Limited was founded by a team of experts carrying over 100 combined years of R&D and industrial analytical leadership — backed by 23 patents, 28+ publications, and deep, practical expertise in global regulatory filings with the FDA, EMA, and PMDA, advanced separation science, and food contact compliance.
We started as the people who built, ran, and were accountable for analytical and regulatory functions inside global organizations. That is why every solution we deliver is scientifically rigorous and aligned with applicable global regulatory requirements, never one traded off against the other.
Collective expertise
Analytical Science Leadership
Chromatography, spectroscopy, elemental analysis & separation science — from method development to IP investigations.
Laboratory Leadership
Designing, establishing, and managing advanced labs, with green analytical chemistry embedded in everyday practice.
Regulatory Strategy
DMF compilation, lifecycle management, dossier defense, and nitrosamine and genotoxic impurity risk assessment.
Our Expertise
Analytical rigor. Regulatory clarity.
Every dossier we build rests on the same foundation: analytical science conducted with rigorous method performance and technical control, and communicated in language a regulator, an auditor, or a board can act on immediately.
Typical capabilities accessible through our laboratory network
Method Development
Custom method development and validation for complex, non-standard matrices — built to applicable ICH guidelines, regulatory requirements, and compendial requirements.
Extractables, Leachables & Migration
Analytical strategies for extractables, leachables, migration and potentially significant chemical constituents across healthcare, pharmaceutical packaging, and food-contact applications.
Nitrosamine & Genotoxic Impurity Risk Assessment
Analytical risk assessment, strategy, and testing coordination for nitrosamines, NDSRIs, and genotoxic impurities, with specialist support coordinated where the scope requires broader toxicological or regulatory assessment.
Root Cause Investigation
Of plant, customer, and device or material failure issues, plus technical evidence supporting IP investigations and infringement disputes.
Regulatory & Dossier Strategy
Support from DMF compilation and submission through lifecycle management.
Polymer & Materials Characterization
Polymer identification, molecular-weight and thermal characterization, additive/degradation assessment, and material equivalence — for polymers, packaging, medical devices, and advanced materials.
Access to advanced instrumentation
Because Bhairvision works through a curated network of appropriately qualified partner laboratories rather than a single fixed facility, clients gain access to a broad range of specialized analytical instrumentation — matched to the question, selected according to project scope and technical requirements.
Industries
Six sectors. One scientific foundation.
Our expertise is not defined merely by the industry. It is defined by the scientific problems we solve across polymeric and other materials that contact medicines, medical devices and food, and in the food and seafood products that cross borders. Every sector has its own rulebook, but the same underlying question: can the data survive an inspection? We build programs engineered to answer yes, sector by sector.
Pharma & Drug Substances
- Method development & validation (ICH Q2/Q14)
- Stability program design (ICH Q1)
- Impurity profiling & genotoxic risk assessment
- Compendial testing (USP/EP/JP)
- Dossier support (ANDA/NDA/MAA)
- Nitrosamine & NDSRI testing for dossier compliance
- Bioanalytical testing & gap analysis
Healthcare, Packaging & Food Contact Materials
One materials science platform. Three applications.
Medical Devices
- Polymer & materials characterization
- Chemical characterization
- Extractables & leachables
- Degradation & failure investigations
Pharmaceutical Packaging
- Container-closure systems
- Extractables & leachables
- Material compatibility
- Packaging related impurities
Food Contact Materials
- Polymer/additive characterization
- Migration & NIAS investigations
- Chemical safety
- US FDA / EU food-contact support
Polymers & Petrochemicals
- Material & polymer characterization
- Molecular weight and molecular architecture characterization
- Catalyst profiling, activity & selectivity testing
- Process and product root cause investigations
- Structure and property correlation
- Customer complaint & performance investigations
- IP / technical support
- Environmental fate & regulatory studies
- REACH / OECD submissions
Agrochemicals
- Environmental fate & regulatory studies
- REACH / OECD submissions
- Residue analysis (LCMS, GCMS)
- Stability & shelf-life studies
- Impurity & degradation profiling
- OECD / FAO dossier preparation
Textiles & Cosmetics
- Chemical safety testing
- Extractables & leachables studies
- Regulatory compliance (EU, US-FDA, BIS)
- Quality assurance programs
- Beauty & personal care compliance testing
Food, Seafood & Export Compliance
- Specialized analytical and regulatory support for global seafood exporters, testing laboratories, certification bodies and regulatory agencies
- EU seafood compliance testing programs
- PFAS (forever chemicals) monitoring
- Dioxins, furans and PCB risk assessment
- Veterinary drug residue monitoring
- Heavy metals and environmental contaminants
- Analytical strategy for international market access
- Regulatory interpretation and compliance consulting
- Accredited laboratory network management
Partner Laboratory Accreditations & Regulatory Recognitions
Recognitions that belong to our partner labs.
Our partner laboratories hold accreditations, certifications, licences and regulatory recognitions relevant to their specific testing activities — including recognitions from NABL, FSSAI, the Tea Board of India, CPCB, BIS, and the Karnataka Drugs Control Department, spanning pharmaceuticals, food, tea, environment, and packaged water. These recognitions belong to the individual laboratories, not to Bhairvision; where accredited testing is required, we select laboratories whose current scope and status are appropriate to the assignment.
Strategic Pillars
Four pillars. One standard of rigor.
Beyond industry solutions, Bhairvision is defined by four strategic pillars that strengthen scientific capability, embed sustainability, build laboratory ecosystems, and enable global regulatory readiness — ensuring clients are not only compliant today, but prepared for tomorrow.
Regulatory Enablement
Global dossier confidence, built on strategy driven by chemistry.
We connect chemistry, analytical science and regulatory strategy from early development through submission and lifecycle management.
- DMF Compilation & Submission Support — FDA, EDQM, PMDA, ANVISA, Health Canada and TFDA
- Lifecycle Management — new submissions, revisions and renewals
- Regulatory Strategy Grounded in Chemistry — integrating chemistry and analytical considerations into regulatory planning
- Dossier & Regulatory Response Support — scientific support for regulatory queries, deficiency letters and audits
Training & Capability Building
Developing people and processes to meet global expectations.
We help organizations strengthen internal analytical and quality capabilities through practical, science-led training designed around real-world laboratory challenges and regulatory expectations.
- Method Validation & Compliance Training — aligned with applicable ICH guidelines and FDA/WHO regulatory expectations
- QC/QA Team Training — building quality-system awareness and audit readiness
- Capability Building — supporting small and growing pharma and regulatory-driven organizations
- Practical Scientist Training — practical guidance in method development, troubleshooting and analytical problem-solving
Green Analytical Chemistry
Embedding sustainability into analytical science.
We integrate sustainability into analytical decision-making — helping organizations reduce environmental impact, resource consumption and cost without compromising scientific rigor or fitness for purpose.
- Greenness Assessment — applying recognized approaches to evaluate the environmental impact of analytical methods
- Sustainable Method Development — embedding sustainability principles into method development and validation
- Eco-Efficient Strategies — reducing solvent consumption, waste and resource use while maintaining analytical performance
Analytical Lab Strategy & Partnerships
Shaping laboratory infrastructure and connecting technology with industry needs.
We help organizations build future-ready analytical capabilities — from laboratory strategy and independent technology assessment to facility establishment and technology partnerships.
- Lab Assessment & Evaluation — independent, evidence-based guidance for laboratory acquisition, technology selection and investment decisions
- New Lab Design & Establishment — end-to-end support in planning, designing and establishing future-ready analytical laboratories
- Technology Partner Development — supporting selected international analytical technology providers seeking technically credible market development and collaboration opportunities in India
- Technology Roadmapping — developing future-ready instrumentation strategies, digital integration and automation pathways
How an Engagement Runs
From scientific question to regulatory-ready outcome.
We follow a structured, risk-based approach — tailored to your product, your existing data, your analytical requirements, and your target markets.
Scope & Gap Assessment
Scope & Gap Assessment
We understand the scientific and regulatory question in the context of your industry. Available data is reviewed, evidence gaps are identified, and a strategy is defined against global regulatory expectations.
Analytical Strategy & Method Development
Analytical Strategy & Method Development
Fit-for-purpose methods are designed, developed, and validated in line with applicable ICH guidelines, regulatory guidance, and compendial requirements — with green analytical chemistry built in from the outset.
Laboratory Execution & Technical Review
Laboratory Execution & Technical Review
Testing is performed by appropriately qualified partner laboratories, selected according to project scope, technical requirements and applicable regulatory expectations, under our direct coordination and critical review. Where required, Bhairvision consultants may witness testing on-site, providing an additional layer of technical oversight and transparency beyond the final analytical report.
Technical & Regulatory Documentation
Technical & Regulatory Documentation
Scientific rationale, analytical results, and supporting evidence are brought together into documentation that is clear, traceable, and defensible before regulators from the first draft.
Regulatory Enablement & Lifecycle Management
Regulatory Enablement & Lifecycle ManagementOngoing
OngoingOngoing regulatory support for DMF submissions, revisions, and renewals — plus regulatory strategy and agency interactions across FDA, EDQM, PMDA, ANVISA, Health Canada, and TFDA — helping clients maintain and expand their position as products and markets evolve.
Why Bhairvision
Evidence that withstands scrutiny.
One Partner, Every Discipline
Most clients juggle separate vendors for method development, training, sustainability consulting, and regulatory strategy. We coordinate analytical, laboratory and regulatory capabilities through one integrated consulting interface — one consistent standard of rigor, from first method validation to final dossier and regulatory response support.
Global Fluency in Regulatory Science
Our regulatory grounding spans FDA, EDQM, PMDA, ANVISA, Health Canada, and TFDA — plus materials and device frameworks including ISO 10993, ISO 14971, ISO 13485, and Indian MDR 2017/CDSCO. Wherever you file, Bhairvision builds evidence aligned with the standard each agency expects — never adapted after the fact.
Accredited, Traceable Data
Testing is performed through appropriately qualified partner laboratories, selected according to the accreditation, regulatory recognition, technical scope and project requirements each engagement calls for — so every dossier rests on data appropriate to its intended use.
Extended Instrumentation Access
Our laboratory partner network gives clients access to a broader base of chromatographic, spectroscopic, and elemental instrumentation than a single facility could sustain.
Sustainability by Design
Green analytical principles are weighed alongside analytical performance, fitness for purpose, safety, cost, and regulatory requirements in our method development work. Sustainability is considered, never imposed at the expense of scientific rigor.
From Material to Evidence
The same disciplined chain, whether the starting point is a drug substance or a medical-grade polymer.
Core Team
Global leaders in analytical innovation and regulatory science.
Experts who have built advanced laboratories, led cross-functional teams across continents, and supported regulator-ready dossiers across major global markets.
Dr. Arun Kumar
Founder & Principal Consultant — Analytical Leadership
PhD, Chemical Sciences — Manipal University
- 30+ years leading analytical science across pharmaceuticals, petrochemicals, catalysts, polymers, and advanced materials
- Senior Manager, Chemical Characterization at GE Plastics and SABIC R&T Centres (Bengaluru & KSA); led cross-functional teams supporting R&D, plant operations, regulatory submissions, and marketing
- Designed and established advanced characterization labs at GE India, GE Silicones, GE Healthcare, and SABIC Bengaluru
- Specialist in chromatography, spectroscopy, catalyst science, and polymer characterization
- 6 patents, 16 peer-reviewed publications
- Recipient of global technology awards at GE and SABIC for analytical innovation and leadership
Ganesh Shivaram Bhat
Principal Consultant — Analytical Science
MSc, Inorganic Chemistry — Karnataka University, Dharwad
- 35+ years as a subject matter expert in analytical R&D across polymers, petrochemicals, fertilizers, pharmaceuticals, fine chemicals, and catalysts
- Staff Scientist specializing in elemental and wet chemistry analysis at SABIC, GE, and leading Indian chemical companies
- Developed analytical methodologies supporting R&D advancement, plant operations, regulatory submissions, and market development
- Certified quality systems expert — GLP QA Manager, ISO 17025 & ISO 9001 internal auditor
- Recognized authority in food-contact polymer compliance across FDA, EU, and Japan PFS regulatory frameworks
- Intellectual portfolio — 6 patents, 20+ technical reports, and peer-reviewed publications
Dr. T. Tilak Raj
Principal Consultant — Regulatory Science
PhD, Organic Chemistry — University of Mysore; postdoctoral research at Georgetown University & the University of Mississippi (USA)
- 35+ years of R&D leadership across pharma, fine chemicals & consulting
- Expert in synthetic organic chemistry — API process development & scale-up
- Dossier compilation & DMF submissions — EMA, FDA, ANVISA, TFDA, Korea, Japan
- Deep GMP expertise — impurity profiling, nitrosamines & genotoxic risk
- 11 US & WO patents · 12 publications
- Trusted advisor to Resonance Laboratories & Combiotech Pvt Ltd
Bhairvision Digital & Innovation
From information and technology to business intelligence.
Bhairvision Digital & Innovation is a separate business vertical of Bhairvision Private Limited. We help organisations turn data into trusted insight, put AI to work responsibly, reach more customers through social media, and build the skills their people need for data-driven work.
Leaders need a clear, shared view of performance and opportunity. We connect data, AI, social media marketing and capability so that every investment in information and technology ends in better decisions and stronger growth.
Our Expertise
Four practices. One aim: decisions you can trust.
Each practice can be engaged on its own or combined into a single programme.
Data Analytics & Business Intelligence
We turn scattered data into trusted insight, giving leaders a clear, shared view of performance and opportunity.
Business value: Faster, better-informed decisions and a single version of the truth.
Key services
- Data strategy and governance
- BI dashboards and executive reporting
- Predictive and statistical analytics
Artificial Intelligence & Machine Learning
We identify where AI creates real value, then design, build and govern solutions responsibly.
Business value: AI investment tied to measurable outcomes, with ethical safeguards.
Key services
- AI readiness and use-case assessment
- Machine learning model development
- Responsible AI governance
Strategic Communications & Social Media Marketing
We create compelling promotional videos and content for Instagram, YouTube, Facebook and other social platforms, helping clients reach more customers and grow sales.
Business value: Wider market reach, stronger brand visibility, and more enquiries and sales.
Key services
- Creative promotional and advertisement videos
- Reels, short-form videos and social media posts
- Social media campaigns and paid advertising on Instagram, YouTube and Facebook
Professional Training & Capability Building
We build practical skills in data, analytics and AI for leaders, professionals and students.
Business value: A workforce ready for data-driven work, with less reliance on outside expertise.
Key services
- Executive and AI literacy workshops
- Data science and analytics programmes
- Customised corporate learning
Clarity
A single version of the truth, so leaders decide faster and on better information.
Accountable AI
AI spend tied to measurable outcomes, governed with ethical safeguards.
Reach
Wider market reach, stronger brand visibility, and more enquiries and sales.
Self-reliance
Teams ready for data-driven work, with less dependence on outside expertise.
A separate vertical. Bhairvision Digital & Innovation operates independently of the Analytical & Regulatory Science consultancy, with its own team, services and engagements.
Get in Touch
Tell us what needs to hold up.
Send us the material, the market, and the deadline. We'll come back with a scoped plan — including where your existing data already covers you.
Phone
+91 88848 87700Office
# 790, Ideal Homes, RR Nagar, Bengaluru, Karnataka, India
Laboratory Partners
Building a network of accredited partner labs. If your laboratory holds recognized accreditation and you're interested in joining our partner network, we'd like to hear from you.
Submit a partner enquiry →