Bridging Science and Business in Regulatory Affairs

At Pharma Consult Pro, we specialize in providing tailored regulatory affairs consultancy services for pharmaceutical products, vaccines, biosimilar, over-the counter (OTC) medicines, and animal health products. Our approach integrates scientific expertise with business acumen, guiding clients through the regulatory landscape to facilitate product authorization and ensure compliance throughout the product lifecycle.

Employing a distinctive “Transformation from Science to Business” methodology that integrates services across the entire health value chain, we can construct a roadmap to facilitate product authorization, compile dossiers and provide continuous post-authorization support. 

Pre-Submission preparation: 

Regulatory Strategy Development

We collaborate with clients to develop comprehensive regulatory strategies, outline, critical pathways and objectives. This foundational planning ensures efficient product development, market entry, and long-term sustainability.

Dossier Auditing

Our team conducts meticulous audits for products dossiers, verifying alignment with current regulatory standards and International Council for Harmonization (ICH) guidelines. We assess documentation formats such as the Common Technical Document (CTD) and Non-eCTD electronic Submissions (NeeS), ensuring compliance with quality and pre-clinical data requirements.

Dossier Compilation and Submission

Comprehensive Dossier Preparation

Leveraging our regulatory strategy insights, we assist in compiling dossiers tailored to both regulated and non-regulated markets. Our experience encompasses pharmaceutical products, dietary supplements, and medical devices, ensuring readiness for submission.

Submission Coordination

We provide end-to-end support for international regulatory submissions, including:

• Electronic Common Technical Document (eCTD) compilation and publishing 
• Submission through various regulatory portals
• Management of deficiency letters and responses

Post-Authorization Support

Lifecycle Management

Understanding the importance of ongoing compliance, we offer services to support products post-authorization:

• Managing variations, renewals and withdrawals
• Reviewing promotional materials, labels and packaging
• Ensuring accurate summaries of product characteristics and patient leaflefts
• Manage and monitoring commercial status

At Pharma Consult Pro, we are committed to building long-term partnerships, providing continuous support to navigate the evolving regulatory environment effectively.