Strategic BioPharmaceutical Leadership for Clinical Development, Medical Affairs & Pharmacovigilance
Europe-based. Globally experienced.
Ways to Work with Reguclin Consulting
Global Clinical Development Strategy
Need an experienced pharmaceutical physician to shape or challenge your development strategy?
- Reguclin supports TPP development, clinical strategy, evidence planning, programme governance and development-pathway optimisation from early development through registration and lifecycle management.
Medical Affairs & Evidence Generation
Need to build an evidence strategy that connects clinical development, Medical Affairs and market needs?
- Support spans Integrated Evidence Planning, RWE, KOL strategy, scientific engagement, medical launch preparation and lifecycle evidence generation.
Portfolio & Asset Decisions
Considering an acquisition, licensing opportunity, new indication or development investment?
- Reguclin provides independent clinical and scientific assessment, due diligence, portfolio prioritisation and development-risk analysis.
Regulatory & Scientific Strategy
Facing regulatory uncertainty or a complex development pathway?
- Reguclin provides scientific and regulatory strategy, health-authority engagement, scientific advice preparation and deficiency-response support.
Patient Safety & EU QPPV
Need experienced pharmacovigilance leadership or independent oversight?
- Support includes EU QPPV, safety governance, RMP strategy, GVP compliance, inspection readiness and remediation.
Fractional / Interim R&D Leadership
Need senior R&D leadership without committing to a permanent appointment?
- Reguclin can provide fractional, interim or project-based physician leadership across Clinical Development, Medical Affairs and Patient Safety.
Who We Work With
Biotech & Emerging Pharma
Independent senior clinical and medical expertise without the cost of building a full internal function.
Established Pharmaceutical Companies
Specialist leadership and strategic support for complex programmes, portfolio decisions and lifecycle opportunities.
Companies Entering Europe
European clinical, medical, PV and regulatory expertise for development and commercialisation.
Investors & Licensing Teams
Independent clinical and scientific due diligence for acquisition, licensing and portfolio decisions.
CROs & Development Partners
Senior physician expertise for programme strategy, scientific credibility and client-facing engagements.
Trusted by Pharmaceutical & Biotech Leaders
Client Case Studies
Rapid FDA Response Strategy
Dr. Siddharth Chachad is a truly outstanding resource for us at Catawba Research and I am delighted to enthusiastically endorse him. One example of his outstanding work happened recently when we needed an extra assistance in addressing an FDA inquiry concerning an NDA we were supporting. Under high pressure to swiftly respond to the FDA's inquiry, Siddharth's ability to deliver a comprehensive and thoroughly researched document in just two days was a key component of our successful response to the inquiry. Siddharth’s commitment to excellence, rapid delivery, and profound understanding of the subject matter played a pivotal role in the overall success of our response.
Dr. Chachad’s proficiency and dedication shone brilliantly as he crafted an exceptional document that not only met but exceeded our expectations. Siddharth's professionalism and collaborative spirit were evident throughout the process. He approached the task with meticulous attention to detail, ensuring accuracy and clarity in every sentence. His adeptness at translating complex scientific concepts into showcased his exceptional communication skills.
Without a doubt, Dr. Chachad’s exceptional performance significantly contributed to our ability to meet the tight deadline and present a well-crafted response to the FDA's question. His dedication and expertise make him an invaluable asset, and I wholeheartedly recommend Siddharth for any future projects that demand excellence, precision, and an unwavering commitment to success.
Andy Silverman, PhD
CEO, Catawba Research
+1 (512) 897-8943
Clinical & Regulatory Strategy for Complex Therapeutic Development
At Koru Lifescience, we have worked with Dr. Siddharth Chachad on multiple early-stage development programs and continue to benefit from his deep expertise in clinical and regulatory strategy. His guidance has been instrumental in shaping clear, risk-mitigated pathways for complex generics, biologics, and novel therapies.
Through Reguclin, Dr. Chachad brings a unique blend of industry and agency perspectives, offering strategic clarity and actionable insights that accelerate development timelines while maintaining regulatory rigor.
We consider Dr. Chachad a trusted partner and highly recommend him to any organization seeking experienced, forward-thinking support in global drug development.
Akhil Jain
CEO, Koru Lifescience
+64 27 882 5555
