Introduction

JUNTOSVIDA (Lifescience) is a multidisciplinary pharmaceutical company focused on the development and global supply of high quality medicines. Our core strength lies in end to end finished product development for high potential molecules, from concept to commercialization, with complete technical support and licensing partnerships for generic supplies. With deep, proven expertise in new product and generic development, technology transfer, and troubleshooting, we help partners bring robust, compliant products to market efficiently.

We provide a wide range of quality, affordable healthcare products including Human and Veterinary medicines, Dental products, Surgical items and Diagnostic's trusted by pharmaceutical wholesalers across geographies.

Quality and Compliance

We operate a comprehensive quality control ecosystem aligned with current Good Manufacturing Practices (cGMP). All essential analytical instruments and data systems undergo full qualification and validation to ensure accuracy and reliability. Quality is our first principle. We have successfully completed multiple customer and regulatory audits and continue to build long-term relationships with domestic and international partners through professional service and uncompromising quality standards.

Product Development

Our development philosophy integrates intellectual property evaluation, patent non infringing strategy, and best in class formulation science. We perform IP landscaping and seek final IP clearances through attorneys for both drug substances and drug products, select API manufacturers capable of supplying patent compliant materials, and design pre formulation and formulation programs aimed at patent non infringing outcomes. Using QbD principles, Design Expert or Minitab, and rigorous analytical support, we define QTPP, CQAs, and risk assessments to deliver optimized, reproducible formulations with clear development reports.

Co Development Expertise

JUNTOSVIDA focuses on niche generic formulations and affordable, life enhancing products manufactured to the highest quality standards. Our leadership brings over 25 years of R&D experience across major markets, including US filings (FTF, ANDA), UK national submissions, and EU DCP applications, with hands on exposure to approximately 500 drug products.

API Development and Commercialization

We support the full API lifecycle, route design and optimization, analytical method development, scale up, technology transfer, and commercialization, ensuring robust, scalable, and compliant processes that integrate seamlessly into downstream product manufacturing.

Analytical Services

We provide comprehensive analytical solutions spanning compendial (USP, BP, EP, JP, ChP), client supplied, and laboratory developed methods. Our capabilities include pharmacopoeial compliance testing, method development, transfer and validation, stability studies, impurity profiling and identification, packaging compatibility studies, polymorphism evaluation, and quality consistency assessment for generics. We test a wide range of sample types, including drug substances, raw materials, QC samples, multiple dosage forms, strengths, and stability samples.

Regulatory Affairs and Operations

Our CMC regulatory team offers strategy, authoring, dossier review, and post marketing lifecycle management across global markets. We provide operational support for submission planning, compilation, publishing, and labeling (SmPC, CDS, CCDS, CCSI, PM), and manage large scale data programs. We enable fully validated, internationally compliant eCTD submissions with proven publishing software and best practices.

Pharmacovigilance

We offer end to end pharmacovigilance support, including QPPV/PvOI services, Article 57(2) electronic submissions, creation and maintenance of PSMF/PvMF, and pharmacovigilance QMS set up and oversight, ensuring safety governance aligned with global regulatory expectations.

Supply Chain Management

Our supply chain services cover demand planning and forecasting, pre launch coordination, production planning, international forwarding and shipping of raw materials and finished products, and data driven performance reporting, enabling reliable, cost effective delivery to market.

Contract Manufacturing and Technology

Transfer We identify and onboard manufacturing partners based on capacity, quality systems, and Ministry of Health approvals in target markets. Our scientific team executes seamless technology transfers and provides on site support at customer designated facilities, addressing technical queries and ensuring rapid scale up to commercial readiness. We work with multiple WHO/EU GMP/USFDA/TGA approved sites for pilot and validation batches.

Clinical and Bioequivalence Study Management

Our in house experts collaborate closely with CROs to design scientifically rigorous and regulatory compliant clinical and BE protocols for India and international markets. Leveraging our strong CRO network, we plan cost effective pilot and pivotal BE studies and coordinate bioanalytical activities to de risk timelines and outcomes.

Medical Writing

We deliver high quality medical writing, including clinical study reports, investigator brochures, and comprehensive medical and scientific literature reviews, ensuring clarity, consistency, and regulatory alignment.

Business Development and Program Management

We tailor partnership models to unlock growth for our clients and partners. Our dedicated project management team drives programs from development through validation, coordinating seamlessly with CROs and CMOs for technology transfer and execution. We embed with client teams to align on culture, processes, and performance metrics, accelerating time to market.

Portfolio Management

We help organizations optimize their pipeline through data driven portfolio evaluation, candidate selection, prioritization, and ongoing optimization, linking scientific value to commercial outcomes to maximize return on investment.

Formulation Reverse Engineering

Our reverse engineering services include qualitative and quantitative composition analysis (API and excipients), assay of API content, packaging evaluation with extractables/leachables studies, impurity characterization with structural elucidation, polymorph quantification, and comprehensive assessment of complex formulations. Comparative studies versus RLD and generics provide a clear roadmap for equivalent performance.

Toxicology and Risk Assessment

We provide toxicological assessments, including PDE/ADE and OEL determinations, and conduct or manage genotoxic impurity risk assessments under GLP and non GLP environments. Capabilities span analytical support, general and genetic toxicology, toxico/pharmacokinetics, bioanalysis, biosimilars, nutraceuticals, and herbal products, aligned with global regulatory guidance.

Infrastructure and Equipment

Our laboratories are equipped with HPLC, GC, UV/VIS and differential refractive index detectors, FTIR, Karl Fischer titrators, multiple USP dissolution apparatus, and qualified stability chambers/rooms. We maintain robust formulation equipment including RMG, extruder spheronizer, mills and sifters, FBD, coaters, compressors, and more—supported by an experienced technical team and validated systems.

Stability Studies

We provide end to end stability program management under ICH and customized conditions, including protocol design, matrixing/bracketing, trend analysis, and shelf life prediction. Our stability infrastructure features real time temperature and humidity monitoring, independent controllers and alarms, UPS and generator backup, and fully validated (DQ, IQ, OQ, PQ) chambers/rooms. Conditions supported include 40°C/75% RH, 25°C/65% RH, 30°C/65% RH, photostability, and stress studies. Stability control software and processes are periodically upgraded to remain fully compliant with ICH guidance. Our team of experienced scientists provides responsive technical support throughout the program lifecycle.

At JUNTOSVIDA (Lifescience)

we are committed to scientific rigor, regulatory excellence, and dependable delivery, partnering with you to transform complex development challenges into successful, sustainable products.

JUNTOSVIDA (IN-VITRO)

offers an integrated suite of in vitro scientific services spanning IVRT, IVPT, BCS classification, in vitro binding assays, and specialized studies on nitrosamines and elemental impurities. Designed to support high value needs in pharmaceutical R&D and quality assurance, our models combine robust science, regulatory alignment, and flexible commercial structures to accelerate development, enable filings, and sustain compliance across the product lifecycle.

Our IVRT and IVPT capabilities are built for topical product development, ANDA submissions, formulation optimization, and post approval change management. We deliver end to end support, including method development and validation, routine release and comparability testing, sameness verification against reference products, and scale up validation. Studies are conducted using industry standard systems such as Franz diffusion cells and leverage expertise across human/animal tissue and synthetic membranes. Engagements may be project based or structured as ongoing partnerships providing continuous analytical support to R&D and manufacturing teams.

BCS services focus on in vitro and in silico assessments of solubility and permeability to inform biowaiver strategy, streamline development, and guide regulatory interactions. Our offerings include dissolution and permeation testing, transport studies, and preparation of regulatory documentation for waiver submissions. By grounding decisions in high quality in vitro evidence, we help reduce the need for costly in vivo studies while maintaining regulatory confidence.

In vitro binding assays support early discovery and preclinical evaluation through high throughput screening and targeted binding studies. These services are suited to mechanism of action exploration, candidate triage, and biosimilar characterization. Engagement models range from per assay and per target arrangements to integrated discovery packages tailored to program needs.

With increasing regulatory scrutiny, our nitrosamines and elemental impurities services address both detection and risk mitigation. We provide advanced analytical testing, such as LC MS/MS for nitrosamines, alongside comprehensive risk assessments aligned with ICH M7 and ICH Q3D, technical audits, root cause investigations, and reformulation guidance. Programs can be scoped per analysis, as full projects that include regulatory reporting, or via retainer for continuous QA oversight.

JUNTOSVIDA serves innovators, generic manufacturers, and contract organizations, aligning every study with current FDA, EMA, and other global regulatory expectations for bioequivalence, product quality, and risk management. Our differentiators include deep regulatory expertise, advanced instrumentation, rapid turnaround, and the ability to bundle complementary services across verticals to drive speed, consistency, and value.

By uniting scientific rigor with flexible business models, JUNTOSVIDA (IN VITRO) functions as a one stop partner for critical in vitro work that underpins regulatory approval, market access, and ongoing compliance.

For inquiries, please contact: info@jv-lifescience.in and info@jv-IN-VITRO.in