Quality & Compliance
Safety & Vigilance
31 january 2023
Introduction: The competitive start-up environment
There is no dearth of innovation thanks to myriad technological advances in the healthcare industry. So much so that it is predicted that the biotech market would be worth USD 2.8 trillion by 2028, with reports stating there are more than 33,000 med-tech companies in Europe itself 95% of which are start-ups. Start-ups with their vision to integrate innovative technologies to solve real-life problems, with an agile task force, are a force to reckon with in current times.
However, the road to innovation is laden with operational challenges, apart from other funding-related hassles. More so with the ongoing pandemic, the fight for resources to fuel these very innovations in healthcare and med-tech has intensified. Added to this, there are challenges pertaining to market research and penetration regarding the launch of innovative products, intellectual property (IP)-related issues, clinical trials and gap analysis, regulatory documentation, and most importantly – hiring a skilled workforce to solve these pertinent issues. The rise of competitor organizations also makes it imperative for each organization to have a tailored approach to product development and launch.
At Product Life Group (PLG), our mainstay is to assist innovators in the biotech and med-tech space, helping them overcome the related challenges to enable them to deliver their best. PLG has both administrative & technical teams to assist the innovators in different stages of the product life cycle – be it strategy, pre-clinical, clinical, quality, manufacturing, regulatory, market access, pharmacovigilance, IT, supply chain etc. PLG also has the capability to connect professionals with varied skill sets across the globe through its strategic partnerships in order to bring the best of all worlds when it comes to launching a new product in the healthcare ecosystem.
We are adequately equipped to support biotech and med-tech start-ups right from a consulting phase, market and regulatory analysis and application dossiers for new products, gap analysis, product life cycle management, preclinical and clinical trial roadmap assessment, regulatory compliance, and through product launch. In its pursuit of excellence to deploy the best possible solutions, PLG is now powered by improved, automated, artificial intelligence (AI) enabled tools for data analysis and management and implementing strategic solutions. Strategic partnerships with organizations like EIT Health help PLG provide a detailed, effective, risk-proof, compliant, and personalized approach to meander through all strategic and regulatory hurdles and launch a product successfully in the market.
Regulatory & Market Strategy:
The first step to succeed at any innovation is to have a go-to-market strategy like no other. The target audience, the key stakeholders, appropriate pricing and reimbursement according to country-specific norms, and intellectual property-related concerns are the keys towards having a clear roadmap. A specific branch of the Group, ProductLife Consulting, has a panel of experts to help with global regulatory, IP & market assessment to define the prospects for the target product.
PLG’s team of experts conducts Health Technology Assessments (HTAs) to capture the pulse of the problem that can be solved by the target product. PLG also assists with Scientific Advice Meetings (SAM) registrations to streamline existing Government norms into the client’s roadmap.
A Delphi panel of technical experts within PLG’s newly minted Research & Innovation division, assist in conducting a structured and exhaustive search on the regulatory & market consensus based on all available data on competitor products. Experts within our Consulting unit conduct budgeting and reimbursement iterations to prepare all applicable dossiers, ensuring the most cost-effective strategies for launching the innovation in the market. The presence of regional teams across countries and continents helps to expedite all registration processes and their compliance in respective countries, and the capability to manage multiple registrations at the same time.
Global strategic alliances allow PLG to help with IP-related concerns, ensuring the target product is secured in every way. Sales and marketing teams ensure there exists a robust promotional strategy for the product once it is launched, by tying up with eminent KOLs in every country along with all key hospitals and medical centers where potentially the product may be of use.
Preclinical, Clinical, Regulatory & Life Cycle Management: From Lab to Market
Traversing the preclinical and clinical aspects of any innovation or entry-level product is laden with challenges. Our teams carry out all the necessary due diligence for any target product, a comprehensive analysis of all related products and competitors alike. For innovations like a drug to combat rare diseases or niche medical devices, or any advanced therapy medicinal products (ATMP), PLG will conduct feasibility checks and prepare all necessary dossiers (TPP/IND/CTA/PIP MDR/IVDR), especially if there are first-in-human trials involved. Alongside, there will be a team to prepare every safety and efficacy document, toxicology report, and CEP, CTR, and CER and even assist physically in targeted meetings with regulatory bodies.
PLG also provides operational support during experiments and clinical trials for any product. Overlooking the entire process, preparing SOPs for specific studies and adhering to applicable GMP/GLP/CGP guidelines. If the clinical trials are outsourced to CROs, PLG will also suggest the best ones in business for your specific needs. We adhere to strict quality assurance (QA) and control (QC) measures throughout the process to ensure the products are as per international standards (ISO/FDA/EMA).
PLG ensures a smooth transition from laboratories to the market. Regulatory documents for both biotech and med-tech start-ups, including all forms of validation and compliance tests, CMC dossiers, risk assessment reports, and technical documents (CTDs) for every stage of the manufacturing process for the product (adhering to ICH guidelines) are provided by a specialized task force. Moreover, PLG also has strategic partnerships with select contract development and manufacturing organizations (CDMO) to partner with start-ups should there be a need.
Even after production, PLG also acts as a facilitator of product licensing as well should the clients so require. Trust PLG’s able team with all NDA/MAA/BLA submissions to regulatory bodies.
IT Support & Post Market Surveillance
PLG has strategically acquired Pharma IT to provide all the necessary IT-based compliance services for start-ups. Being a start-up, there are multiple constraints, and developing physical networks is a major bottleneck when it comes to augmenting resources in order to get the job done. Considering there is a lot going on in data privacy and security when there are clinical trials and patient data involved, PLG uses its strategic partnerships to provide cost-efficient secured cloud-based IT solutions for optimal security, data management, and quality compliance (GDPR, DPO). All solutions provided are scalable to suit a company’s growth and expansion in the times to come.
PLG’s journey with a start-up does not end with its product launch. Adhering to its commitment to providing end-to-end support, PLG also assists in preparing post-market surveillance (PMS) data, periodic safety update reports (PSUR), and post-market clinical follow-up studies (PMCF), to ensure that its clients are always at the top of their game when it comes to product iteration and quality enhancement.
PLG has successfully handled multiple start-ups and innovations in the past. Some of the most noteworthy ones are providing market access for the launch of a novel, diagnostic blood test to detect bipolar disorder, ensuring a seamless market access solution for reimbursing a digital health solution that allows early detection of risks of recurrence or complications for lung cancer patients, among others. Additionally, PLG has helped in conducting due diligence and end-to-end clinical project management for a New Chemical Entity (NCE) for a start-up that targeted Non-Alcoholic Fatty Liver Disease (NAFLD) & Steatohepatitis (NASH), provided scientific advisory and market intelligence to a start-up in getting regulatory approval for a monoclonal antibody targeting multiple sclerosis (MS) – both the cited cases are in the EU. But not only in the EU, PLG has been instrumental in assisting organizations to achieve market access and regulatory clearance for biomolecules in multiple countries, globally.
If you are focusing on innovation, consider PLG as a long-term partner. Be it strategy, product development, quality, and/ or regulatory matters. If you have a start-up that has just been incubated or have secured a project to grow your footprint or have an innovation to address key challenges in the existing healthcare repertoire, look no further. PLG’s holistic solutions and multidisciplinary expertise connect people globally to come forth and accelerate start-ups as one team – a way to give back to the community through effective and enriched access to high-quality healthcare.
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