❓FAQ📝
Answer: Our main focus is on providing comprehensive API sourcing solutions for small- and medium-sized generic pharmaceutical manufacturers. We connect clients directly with vetted manufacturers to ensure optimal pricing, quality, regulatory compliance, and supply reliability without intermediary markups.
Q1: What is the main focus of your API sourcing services?
Answer: Unlike traditional procurement methods that often rely on intermediaries or non-specialized teams, our approach emphasizes direct connections with manufacturers, in-depth supplier vetting, and local expertise in key API manufacturing regions. This ensures more transparency, better pricing, and greater supply security.
Q2. How do you differentiate your sourcing process from traditional procurement methods?
Answer: Small- and medium-sized generic pharmaceutical companies, particularly those without dedicated in-house sourcing teams, benefit most from our services. We also support larger companies that require strategic sourcing assistance for specific API projects.
Q3. Which types of pharmaceutical companies benefit most from your services?
Answer: Our supplier vetting process goes beyond basic checks and includes an evaluation of GMP certifications, regulatory compliance, production capabilities, financial stability, and potential risk factors. We also organize GMP audits and assess suppliers for long-term reliability and sustainability.
Q4. What makes your approach to supplier vetting comprehensive?
Answer: We ensure compliance by working only with suppliers that meet stringent GMP and regulatory standards. Our experts in key manufacturing regions stay updated on evolving regulations and conduct thorough audits, sometimes partnering with independent GMP-certified auditors for added assurance.
Q5. How do you ensure compliance with GMP and regulatory standards?
Answer: Our global network includes experts in China, India, Taiwan, South Korea, the EU, and Latin America. This coverage allows us to access reliable local insights, navigate regulatory landscapes, and diversify sourcing options, which reduces supply chain risks and ensures the best supplier fit for each project.
Q6. What regions does your global network cover, and why is this important?
Answer: Yes, we have helped clients achieve cost savings of up to 40% through strategic sourcing. For example, in one critical and time-sensitive project, we identified alternate API sources for a Taiwanese client whose API supplier faced compliance issues – and we helped them not only qualify two alternate suppliers for that API, but also reduce their material costs by 38%.
Q7. Can you share examples of the cost savings your clients have achieved?
Answer: We manage sourcing risks by conducting thorough supplier vetting, ensuring compliance with GMP standards, diversifying sourcing across regions, and maintaining open communication with clients. Additionally, our team stays proactive in assessing geopolitical and economic factors that may impact supply stability.
Q8. What steps do you take to manage and mitigate sourcing risks?
Answer: We specialize in managing complex projects involving custom API development. Our process includes defining requirements, engaging niche developers globally, negotiating development agreements, organizing GMP audits, and overseeing progress from concept to DMF filing to ensure quality and compliance.
Q9. How do you support companies that need custom API development?
Answer: Direct access to manufacturers eliminates intermediary markups and ensures that clients receive the best possible pricing. It also fosters stronger supplier relationships, improves communication, and reduces the risk of supply chain misunderstandings.
Q10. Why is direct manufacturer access beneficial for clients?
Answer: These companies often lack the specialized expertise needed for comprehensive supplier due diligence, leading to dependency on traders and higher costs. We address these challenges by leveraging our industry knowledge, global network, and thorough vetting process to ensure that clients find the best API sources at competitive prices.
Q11. What challenges in API sourcing do small and medium-sized companies typically face, and how do you address them?
Answer: We prioritize transparency by keeping clients informed at every stage of the process. We provide detailed reports on supplier evaluations, negotiate on the client’s behalf without hidden fees, and maintain open communication to ensure clients know exactly how their sourcing strategy is being executed.
Q12. How do you maintain transparency throughout the sourcing process?
Answer: After the initial supplier selection, we continue to support clients with supplier relationship management, regular performance reviews, and proactive issue resolution. This ensures that supplier partnerships remain strong and aligned with the client’s needs over the long term.
Q13. What type of ongoing support do you provide after the initial supplier selection?
Answer: We are experienced in managing urgent requests and last-minute changes by leveraging our global network to quickly identify alternative suppliers. Our structured yet flexible approach allows us to adapt and respond rapidly, minimizing disruptions and ensuring that clients stay on track with their timelines.
Q14. How do you handle urgent sourcing needs or last-minute API changes?
Answer: Our risk assessment process involves evaluating each potential supplier’s history, compliance status, production capabilities, financial health, and location-specific risks. This comprehensive