With only 1 in 10,000 compounds reaching clinical trials, staying ahead is a necessity. High failure rates demand a data-backed approach to molecule selection.
We leverage AI/ML for predictive modeling and competitive analysis. Our strategy identifies the shortest regulatory pathways to optimize your investment.
About us
Shaping Global PV Strategy. Accelerating Market Success.
Founded by Dr Shripadaraja R, an industry leader with over 18 years of hands-on experience, GPLACO SOLUTIONS provides specialized advisory for Marketing Authorization Holders (MAHs) and Sponsors. Our expertise is rooted in shaping global Pharmacovigilance strategies across the US, UK, EU, and APAC regions.
With a proven track record of managing over 250+ products, we help our clients implement robust PV Quality Management Systems (QMS) and streamline complex processes. By establishing global ICSR case management, Literature surveillance, proactive Signal Detection, and Risk Management Plans (RMP) we identify early risks and mitigate them effectively contributing for Benefit-Risk and directly accelerating product approvals and commercialization.
Diverse Therapeutic Expertise:
Our strategic oversight spans a vast array of complex therapeutic areas, ensuring tailored safety solutions for every asset:
Oncology & Immuno-Oncology: Navigating complex safety signals in advanced cancer therapies.
Neurology & CNS: Specialized monitoring for chronic and degenerative conditions.
Cardiovascular & Metabolic: Managing high-volume data for global patient populations.
Rare Diseases & Orphan Drugs: High-touch safety strategies for small, critical patient cohorts.
Infectious Diseases & Vaccines: Rapid-response PV for emerging global health needs.
Immunology & Rheumatology: Long-term safety oversight for biologics and biosimilars.
Our Mission
Empowering Success in Pharma and Biotech Ventures
We are on a mission to transform the landscape of pharmaceutical and biotech market entry. Through the strategic application of AI/ML, we aim to expedite the journey from product development to market penetration, providing our clients with a competitive edge in the dynamic and evolving life sciences sector.
Our Vision
Pioneering a Future of Seamless Innovation in Life Sciences
At GPLACO Solutions, we envision a future where innovation in the life sciences industry is not just a goal but a seamless reality.
Our vision is to be at the forefront of transformative advancements, driving positive change and accelerating the journey from scientific breakthroughs to global impact.
Why us
Each client we engage with poses the most important question: “What sets GPLACO Solutions’ AI/ML Integrated Services apart?”
Here is what we say on call: If your organization aspires to achieve strategic goals and aim for:
Phase I–IV leadership ensuring signal detection and Risk identification is integrated from Clinical Trials through to post-marketing.
Deep regulatory intelligence for US (FDA), UK (MHRA), EU (EMA), and Japan (PMDA) markets.
200+ GVP audits executed, preparing MAHs & Sponsors for successful global regulatory inspections with no critical findings.
Comprehensive Safety Evaluation & Risk Management to identify and mitigate risks early.
Establishing robust Quality Management Systems and PSMF frameworks for global compliance.
Strategy for 250+ products, accelerating approvals and ensuring long-term license integrity.
Ensuring that tasks are performed to high standards and in compliance with industry regulations.
Efficiency and automation lead to substantial cost savings across various operational aspects
Benefits and values
Why Engage with GPLACO SOLUTIONS?
Global Drug Safety & PV Expertise – FDA, EMA, MHRA, PMDA and TGA
ICSR Case Management (End-to-End)
•98%+ QA-verified ICSR quality, assuring high quality
•24–72 hour expedited reporting for 7/15 days timelines
Literature Monitoring & Surveillance
•100% screening for valid ICSRs, Signals and Risks
•AI-enabled dual screening & QC, for compliance
Aggregate/Periodic Reports (PADER/ PSUR / PBRER / DSUR)
•ICH E2C/E2F compliant reports accepted by global regulators
•100% on-time high-impact and quality reports submissions
Signal Detection & Management
•ICH E2E & GVP Module IX aligned global signal process
•Statistical analysis and validation from medical experts
RMPs Vs REMS expertise
•Global RMPs & REMS with minimal HA queries
•Proactive risk minimization and mitigation strategies supporting global approvals for products
PSMF Development & Maintenance
•Inspection-ready PSMFs aligned to EMA & MHRA expectations
•Zero critical inspection findings across global audits
PV QMS & GVP Audits Excellence
•Robust global PV QMS enabling risk-based compliance for MAHs, Sponsors, CROs and partners
•200+ global PV audits executed resulting in Zero critical findings during regulatory inspections
•Risk-based assessment and global audit plan strategy tailored to your portfolio
Choosing GPLACO SOLUTIONS means gaining a strategic partner who goes far beyond support in discovery and clinical trials.
With 18+years of deep global experience, we help life sciences organizations plan, de-risk, and execute across the entire product lifecycle — from early development to post-approval.
Our core strength lies in world-class pharmacovigilance, reinforced by robust regulatory strategy and quality assurance frameworks. We proactively assess safety, efficacy, effectiveness, benefit–risk balance, and risk mitigation, enabling informed decision-making at every critical milestone.
By embedding compliance, scientific rigor, and governance early, we help you:
Reduce downstream regulatory risk
Avoid costly delays and rework
Strengthen inspection readiness
Accelerate approvals, pricing, and market access
Our ultimate focus is simple and measurable: delivering safer, higher-quality medicines that meet global regulatory expectations and succeed in the real world.
Data accuracy and precision screening across clinical trials and Post-approval safety reporting
Assured Safety profiles with 100% DLP Regulatory submission and minimal Health Authority (HA) queries
Early detection of safety concerns with effective risk minimization measures ensuring product safety
Zero critical observations for MAHs and Sponsors across Regulatory inspections for FDA, EMA, MHRA, PMDA and TGA
Few Remarkable Accomplishments & Distinguished Milestones
Exploring GPLACO’s Commitment to Safer Medicines and Industry Advancements
Achieved a breakthrough by introducing process automation and innovative problem-solving strategies.
Demonstrated leadership in successfully spearheading complex projects, showcasing proficiency in resource and budget management.
Has innovatively used automation, artificial intelligence, and machine learning to address critical industry pain points.
Recognized for his profound expertise in addressing challenges related to data quality, adverse event management, signal detection, and risk assessment in the pharmaceutical domain.
Efficient Outsourcing Solutions
The company specializes in streamlining outsourcing processes for pharma and biotech companies, effectively addressing pain points associated with quality and compliance.
Whether you are planning R&D, drug discovery, clinical trials, pharmacovigilance, or AI-enabled pharma and biotech transformation, engaging GPLACO SOLUTIONS as your strategic partner is a decisive first step toward success.
Explore our expert insights to understand why leading organizations choose us.
How do we bring it to fruition?
Our comprehensive suite of services is meticulously crafted to address the unique challenges of the pharmaceutical industry. Through collaborative partnerships and cutting-edge technologies, we bring your vision to life, revolutionizing the way you operate, innovate, and succeed.
#1
Predictive Modeling and analytics
Anticipate Industry Trends: Our predictive modeling identifies emerging trends, enabling proactive decision-making in the rapidly evolving pharmaceutical and biotech landscape.
Early Identification of Breakthroughs: Stay ahead in innovation by leveraging predictive modeling to identify potential breakthroughs, facilitating early adoption and strategic positioning.
#2
Market Intelligence and Competitive Analysis
Informed Decision-Making: Comprehensive market intelligence provides a clear understanding of the competitive landscape, empowering informed and strategic decision-making.
Competitive Advantage: Gain a competitive edge with detailed analyses of market trends, competitor activities, and key opportunities that shape the pharma and biotech industry.
#3
Data-Driven Strategies
Strategic Alignment: Develop tailored strategies based on robust data insights, aligning your goals with market demands and ensuring a focused and effective approach.
Precision in Resource Allocation: Utilize data-driven strategies to optimize resource allocation, enhancing efficiency and maximizing returns on investment.
#4
Market Access
Strategic Market Entry: Our comprehensive approach ensures that regulatory compliance aligns with market access strategies, facilitating a smooth entry into the market.
Sustainable Success: Achieve and sustain market access by combining predictive modeling, market intelligence, and data-driven strategies for a holistic and enduring impact on the pharma and biotech industry.