Regulatory Strategy Consulting Services

Maximize your product’s global success with X Pharma Plus. Our regulatory strategy consulting delivers efficient compliance and a smooth pathway to international market entry.

Regulatory Strategy Consulting Services – Overview

Pharmaceutical companies often face challenges in optimizing time, resources, and regulatory strategies to ensure compliance while achieving business goals. Expert regulatory strategy consulting is essential for navigating product commercialization and drug development successfully. Key challenges include:

Addressing drug development issues, such as impurities, analytical concerns, stability, and container-closure system matters
Planning regulatory strategies for high-volume work arising from acquisitions or business integrations
Designing global clinical trial strategies during drug development
Strategically planning regulatory submissions with limited data or anticipated regulatory risks
Managing Reference Medicinal Product (RMP) challenges across multiple markets
Supporting Complete Response Letter (CRL) submissions or responses to Health Authority queries
Facilitating the expansion of approved products from one region to other regulated markets (e.g., USA to Europe and vice versa)

A trusted regulatory affairs consulting partner is critical to the successful commercialization of medicinal products. X Pharma Plus combines deep expertise, global market knowledge, and a proven track record to guide pharmaceutical and biotechnology companies through complex regulatory requirements, ensuring efficient, compliant, and successful product development and market entry.

Services

“Regulatory Strategy Consulting Services help pharmaceutical and biotech companies navigate complex global regulations by providing expert guidance, submission planning, and compliance solutions to achieve timely product approvals and market access.”

Strategic planning and submission of regulatory applications across global markets
Regulatory compliance consulting to address Health Authority (HA) queries and Complete Response Letters (CRLs)
Preparation and submission of BLAs (Biologics License Applications) and MAAs (Marketing Authorization Applications) for recombinant therapeutic proteins, vaccines, and advanced therapy products, including stem cells and tissue-based products
CMC consulting for preparation and submission of regulatory dossiers, such as INDs, NDAs, ANDAs, MAAs, NDS, ANDS, DMFs, ASMFs, IMPDs, and more
Regulatory strategies for drug expansion into new markets
Post-approval change management and regulatory compliance consulting
Pre-submission interactions and guidance with Health Authorities
Competitor landscape evaluation and development of regulatory strategies or mitigation plans, including expedited program requests
Consulting for Orphan Drug Designation (ODD) applications and other accelerated regulatory programs
CMC support for Quality by Design (QbD) protocols and reports
Development of biosimilars and biological products
Pharmaceutical regulatory consulting for market entry and cross-border registrations
Regulatory guidance for combination products (Device + Drug/Biologic)
Evaluation of pharmaceutical excipients against the IIG database (Inactive Ingredient Guide Database)
Defining tests and risk assessments for genotoxic and elemental impurities
CMC consulting for stability studies, including bracketing and matrix approaches
Identification of Reference Medicinal Products (RMPs) and regulatory pathways in global markets
Selection of Reference Member State (RMS) for European submissions
Guidance on responding to HA queries and dossier amendments
Support for formulation or route-of-administration changes and regulatory registration (e.g., 505(b)(2), hybrid applications)

Access to regulatory consultants up-to-date with global regulatory changes
Full compliance with international Health Authority requirements
Experienced team of pharmaceutical regulatory professionals
Customized, strategic regulatory planning to optimize approvals and market entry

Clinical Trial Application (CTA) Submissions