Industries
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Pharmaceuticals
We focus on high-barrier generics in the wide range of therapeutic areas including cardiovascular, oncology, immunology, respiratory, diabetes, HIV, neurology, men’s and women’s health and orphan diseases.
We also support and collaborate with biotechnology companies which create novel medicines addressing the most challenging clinical conditions.
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Medical Technologies
Our key areas of interest comprise IVD medical devices for diagnostics of infection diseases and non-communicable diseases (oncology, cardiovascular, chronic respiratory diseases and diabetes), as well as imaging systems used in diagnostics and surgery.
That includes both stationary medical systems and mobile point-of-care devices, equipment for professional use at hospitals, laboratories and mobile emergency units, and devices suitable for non-professional use at workplace, public transportation, other public areas and at home.
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Telehealth
In Telehealth we focus on point-of-care solutions and platforms for remote monitoring of chronic and post-operational patients, general health monitoring, conducting medical exams on-demand (medical check-ups) and supporting patients’ compliance to treatment. Those solutions integrate secure collection and storing of medical data, flexible design, high levels of compatibility with hospitals information systems and AI functionality for detection of critical medical conditions.
Some of those systems are designed for fast deployment and adaption in the field and in ad hoc hospitals and capable to support provision of most of primary care services. Such solutions are suitable particularly in emergencies and for efficient expansion of medical services in hard-to-reach regions.
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Nutraceuticals
In the field of dietary supplements we specialize in nutraceuticals with proven medicinal benefits, supported by clinical studies and recommended by medical practitioners.
Those products usually would combine original formulations, developed by biotech experts and medical professionals, with active ingredients of pharmacopeial quality and advanced dosage forms for increased bioavailability. Production quality is ensured through implementing full scale QA and QC procedures at GMP-certified manufacturing facilities. Notably, such products would frequently utilize patented technologies confirming their uniqueness and novelty.
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Wellness Technologies
Wellness industry rests on broad spectrum of health technologies, varying from smart personal devices and digital assistants to integral platforms and services, helping individuals and organizations to efficiently identify and mitigate health risks, create safer environment, and motivate to healthier behaviors.
We work with products and services that address the needs of both the individuals and organizations which seek to create safe and healthy environment.
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Cosmeceuticals
Cosmeceuticals have both therapeutic and cosmetic uses, providing substantial health benefits and targeting specific conditions of skin, hair and mucosa, such as acne, dermatitis, psoriasis, eczema, hyperpigmentation and others.
The medicinal qualities of cosmeceuticals go far beyond those of conventional cosmetics and are achieved through complex formulations of high-quality active ingredients including peptides, antioxidants, probiotics, botanical extracts, hydroxy acids, vitamins and others. Most of those ingredients are well known in pharmaceutical industry for being used regularly in pharma grade products.
Notably, therapeutic claims of cosmeceutical products are expected to be supported by clinical evidence, although normally that would not be included as a mandatory requirement under the applicable regulatory frameworks.
What we do
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Technology Scouting & Audit
For each technology, product or service we develop, structure and execute full scale scouting and audit process.
Such scouting and audit process comprises the following stages: (1) technology search, (2) technical audit, (3) review of the technology source and origin, (4) developer’s team expertise, (5) product pipeline and technology applications, (6) IP protection considerations, (7) manufacturing capacities and quality standards, (8) technical file (dossier) quality, clinical validations and product registrations, (9) commercial track record of the technology, (10) primary regulatory requirements (country-wise), (11) optional marketing strategies, and (12) developing a draft business case (market-wise).
Through the comprehensive audit algorithm we ensure that the relevant technology is being landed in the market with the right partner. The marketing aspects are crucial for the successful introduction and utilization of a new technology. Hence those are included as an integral part of the audit process.
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Tech Transfer Support
Each technology transfer project is unique: it requires adaptation of the licensed technology and the production processes to new facilities, different raw materials, other regulatory environment, market conditions and the scale of the expected production. Those aspects are linked directly to the specific business model developed for each project and the applicable contractual terms. We assist the parties engaged in the tech transfer project to make sure that all aspects are aligned and build the joint workflow.
In particular, we assist in preparation of the feasibility assessment for the proposed tech transfer, drafting the project road map, describing and allocating the transferred stages of production, conducting the audit of the transferee’s facilities (equipment, infrastructure requirements, production laboratory capacities, quality management systems, environmental compliance, staffing requirements), sourcing the raw materials and equipment, planning the training programs and defining the scope of the technical support.
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In-Licensing & Out-Licensing
Our global partnerships with the trusted pharmaceutical manufactures, biotech companies and leading distributors ensure availability for licensing of a wide pipeline of generic and original drugs in the key therapeutic areas.
We design and support licensing project from the initial introduction of the candidate and till the pharmaceutical product is registered and released to the market. In particular, we conduct dossier assessments, evaluate market potential, review applicable regulatory requirements, assist with the registration strategy design, draft the business case and advise on the licensing deal structure. If required, we assist in obtaining GMP certifications required for the target market and support technology transfer.
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Product Development
We offer product development, consulting & management services from the very early stages of concept development and prototyping to release of finished products. We design development plan and manage projects for our clients, working closely with their R&D, manufacturing and marketing teams. We also engage and manage suitable contractors and assume responsibility for the development project till its completion. Thereafter, we advise on scale-up and technology transfer, as well as on sourcing the components and raw materials, as might be required.
Our product development services relate mainly to the segments of Medical Devices, Nutraceuticals, Cosmeceuticals and Wellness.
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Route-to-Market
We provide full marketing support for technology companies interested to introduce their products and services to new markets, from the initial review of the available market opportunities through drafting a detailed marketing plan and until the product is launched to the market.
If required, we also identify potential partners for commercializing of the technology in the market of interest, assist in deal structuring and negotiations with such candidates through closing.
While creating the marketing strategy, we take into consideration clinical aspects of the technology, regulatory requirements, available registration options, standards of care applicable in the healthcare system, as well as legal standards governing promotion and advertisement of a product or a service. We also initiate and assist in preparing programs for clinical validations and technical assessments of the new technology as might be required for efficient promotion in a specific market.
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Assitance in Regulatory Affairs
We assist in shaping an efficient regulatory strategy for the full life-cycle of a product or a service that is being introduced to the market.
That includes advice on the registration and certification options to ensure the shortest time-to-market periods, broader clinical application and suitability for the existing standards of care, flexibility for the potential follow-up registration amendments, compliance with the public procurement requirements and most importantly – securing that the unique qualities of the product are reflected properly in the registered documents. Where appropriate we also suggest amendments to the technical file (dossier) of a product and advise on additional clinical and technical trials.
We support on-going commercial operations in establishing and managing mechanisms for compliance with the post-launch regulatory standards and, where applicable, the product disposal requirements.
We also assist in certification of production facilities for compliance with GMP, ISO 13485 and other standards, assessing and establishing QA and QC systems, all as might be required by the applicable regulations to ensure sustainable and efficient operation.
