Industries We Serve
Built for the
Complexity of Your Industry.
Our integrated model is tailored for three distinct life-sciences verticals — each with its own regulatory landscape, clinical complexity and market-access dynamics. One quality system, three deeply specialised practices.
Why Industry Specialisation Matters
One Integrated Model. Three Deeply Specialised Practices.
A small-molecule oncology asset, a Class III implantable, and an ultra-rare gene therapy don't share an evidence playbook. Vigilare staffs each industry vertical with named senior experts who understand the agency, payer and clinical realities specific to that space — backed by one shared quality system.
Phase I–IV+ Full Lifecycle
Industry 01
Pharmaceutical & Biotech
Small Molecule Biologics Cell & Gene Generics
From IND-enabling studies and Phase I through global NDA/MAA submissions, post-market PV, and HTA strategy — Vigilare delivers the full regulatory and clinical lifecycle for emerging biopharma, mid-size specialty pharma and global innovators who need end-to-end support without enterprise overhead.
- IND, NDA, BLA, MAA, ANDA, 505(b)(2) submissions across five agencies
- Phase I–IV trial operations, CDM, biostatistics and SAS programming
- Pharmacovigilance with EU QPPV cover and 24/7 multilingual case intake
- HTA dossiers (NICE, HAS, IQWiG, PBAC) and HEOR from Phase II
CE-MDR+ FDA + CDSCO
Industry 02
Medical Devices & IVD
Class I–III IVD A–D SaMD Combination Products
CE-MDR transition, FDA 510(k) and PMA submissions, CDSCO device registrations, clinical evaluation reports, and post-market clinical follow-up across jurisdictions — delivered under a single ISO 13485-aligned quality system. Predictable cost, predictable timeline.
- EU MDR + IVDR technical files and notified body liaison (BSI, TÜV SÜD, DEKRA)
- FDA 510(k), De Novo, PMA and IDE submissions
- CDSCO device and IVD registrations with Indian authorised agent services
- Clinical Evaluation Reports (CER), PMCF, vigilance and FSCA reporting
ODD+ Adaptive Designs
Industry 03
Rare Disease & Specialty
Orphan Drug Breakthrough PRIME Ultra-Rare
Orphan drug designations, breakthrough therapy programs, adaptive trial design, HEOR for ultra-rare indications, and named-patient & early-access strategies. Built for the unique evidence challenges of small-N populations where every patient counts and every endpoint matters.
- Orphan Drug Designation (US + EU), Breakthrough Therapy and PRIME applications
- Adaptive, basket, platform and master-protocol trial design for small-N populations
- HEOR with synthetic comparators, MAIC, and ultra-rare disease modelling
- Named-patient supply, ATU (France), expanded access (US) and EAP programmes
3Specialised Verticals
30+Markets Served
5Major Agencies
10+Years Cross-Industry
Why It Works Across Industries
Specialised Where It Matters. Shared Where It Counts.
Four reasons sponsors across pharma, MedTech and rare disease consolidate their CRO + regulatory work with Vigilare.
One Quality System Across All Verticals
ISO 9001:2015 certified, externally audited annually. Same SOPs, same training matrix, same CAPA framework — whether you're a biotech, device manufacturer or rare-disease sponsor.
Named Senior Leads. By Vertical.
You work with the senior expert whose career is in your industry — not a generalist who context-switches between a Class III implant and an oncology MAA.
Multi-Jurisdiction From Day One
Every vertical's lead is fluent in FDA, EMA, MHRA, TGA and CDSCO requirements — global submissions designed in parallel, not serially.
Integrated Service Bundles
PV + RA + CRO + MA + Quality + Device — bundle as needed, scaled to your stage. No vendor sprawl, no integration tax at submission time.
FAQs
Industry Coverage, Answered.
01
Do you support combination products (drug-device)?
Yes. Combination products are handled by joint engagement between our pharmaceutical and device practices — submitted via the primary mode of action pathway (FDA OCP, EMA borderline) with constituent-part documentation aligned to both drug and device requirements. Common engagements include drug-eluting devices, prefilled syringes and biologic-delivery systems.
02
Can you support a biotech with no in-house regulatory team?
Yes — this is one of our most common engagement models. We act as the full outsourced regulatory + clinical + PV function for emerging biotechs, from first IND through approval. Named senior leads embed into your team, so it functions as if you had in-house staff without the fixed cost.
03
What's different about rare-disease trial design?
Small-N populations require non-traditional designs: basket trials, platform trials, master protocols, single-arm with synthetic controls or historical comparators, adaptive Bayesian designs, and N-of-1 approaches. Our rare-disease practice has direct experience across rare oncology, neurology, metabolic and genetic indications.
04
Do you handle SaMD (Software as a Medical Device)?
Yes — IEC 62304 software lifecycle, IMDRF SaMD framework, FDA pre-cert pilot alignment, AI/ML device guidance and EU AI Act overlap. We support stand-alone SaMD, embedded device software, and clinical decision support tools across both EU and US pathways.
05
Which industry verticals do you NOT serve?
We focus exclusively on regulated life-sciences: pharmaceuticals, biologics, medical devices, IVDs, and combination products. We do not serve consumer health (non-Rx), dietary supplements, cosmetics or veterinary medicines — these have very different regulatory regimes and we believe in deep specialisation over surface breadth.
Our Services
Six Service Pillars. Mix as Needed.
Engage Vigilare across one workstream or as your end-to-end CRO + regulatory partner.
Whatever your vertical — let's map the right pathway.
Speak to an industry-matched senior lead — not a sales rep. We'll scope your stage, map the gaps and propose a path in one focused call.