MedPharm offers a suite of expert services designed to support clients at every strategic and operational phase of pharmaceutical development to give you enhanced clarity, confidence, and compliance.  

Consultancy

With decades of specialized experience in topical, transdermal, and complex drug delivery systems, MedPharm’s consultancy services are grounded in scientific rigor and real-world success. Our experts collaborate with clients to define optimal development strategies, troubleshoot technical challenges, and identify opportunities for innovation and efficiency.  

Our consultancy services include: 

• Feasibility assessments and early development planning 

• Formulation and product lifecycle strategy 

• Device-drug combination guidance 

• Support for business development, licensing, and M&A evaluations

We don’t just advise—we solve, support, and accelerate your path to success.  

GAP Assessment

Uncover Weaknesses. Unlock Opportunities. 

A thorough GAP Assessment is essential for identifying discrepancies between your current development or documentation state and industry or regulatory expectations. MedPharm’s approach is both systematic and insightful, leveraging our quality and compliance expertise to align your project with global standards.  

Our GAP assessments cover: 

• Documentation and data completeness 

• Regulatory submission readiness 

• Process and methodology gaps 

• Validation and verification protocols

We help you bridge the divide between where you are and where you need to be—efficiently and effectively. 

Risk Assessment

De-risking Development with Science and Precision 

In the high-stakes world of pharmaceutical development, anticipating and mitigating risks can mean the difference between delay and delivery. MedPharm conducts comprehensive, scientifically grounded risk assessments to identify vulnerabilities in your product design, development processes, and regulatory plans.  

Key areas we evaluate include: 

• Formulation performance and stability 

• Manufacturing scalability and process transfer 

• Regulatory hurdles and approval timelines 

• Clinical trial material readiness

Every assessment is customized and actionable, giving you the foresight to plan confidently and pivot when needed.  

Regulatory Support

Global Expertise. Local Insight. 

Navigating regulatory pathways is a cornerstone of MedPharm’s value. With a successful track record across the FDA, EMA, MHRA, and other international bodies, our regulatory support services are designed to streamline submissions and reduce time to approval.  

Our regulatory services include: 

• IND, IMPD, and CTD documentation preparation 

• Data package development and review 

• In vitro bioequivalence strategy and justification 

• Post-submission query resolution and support

Whether launching a novel therapy or a complex generic, we guide you through every regulatory milestone with clarity and confidence.