At PharmaConsultPro, we provide services in Regulatory Affairs with Global turnkey solutions for Pharmaceutical products, Vaccines, Biosimilars, OTCs and Animal Health. 

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

At PharmaConsultPro, we devise a foundational document clearly outlining the critical regulatory pathways and objectives ensuring adequate planning to bring new products to market, as well as the overall sustainability and the product end of life. 

Dossier audit

We perform audits for products or active substances, which include verification of its contents with the current regulatory standards and the ICH guidelines. We also perform dossier audits (CTD, NeeS Format) with attention to the smallest details, using appropriate standards implemented within the company. We take great care to ensure that the content of the dossiers complies with International or national guidelines on the quality data as well as pre-clinical data of original, generic and well-established medicinal products.

Dossier compilation

Understanding the regulatory strategy, our team have extensive experience in preparing dossiers suited to the regulated and non-regulated markets with a strong competency in pharmaceutical products, dietary supplements, and medical devices.

Submission

Our experts will plan and coordinate every detail of a clear and complete International regulatory dossier submission. We’ll utilize our extensive regulatory and scientific experience engaging with regulatory authorities to optimize the submission process. Our team of experts will work with clients ensuring successful:

• eCTD compilation and publishing 
• Submission of eCTD using various portals
• Support and management of deficiency letters

Post-authorization

We understand the importance of building a long-term relationship with clients and supporting them during the full lifecycle of a product (from concept to launch and post-marketing). Our team at PharmaConsult Pro will ensure that appropriate measures are taken for product regulatory compliance by contributing to the:

• Full lifecycle support
• Variations
• Renewals
• Withdrawals
• Reviewing promotional materials
• Finalizing labels, a summary of product characteristics, leaflet,
• Reviewing packaging material
• Manage commercial status