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Regulatory Solutions for Middle East, North Africa, and Europe

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Project Information

  • Name Regulatory
  • Delivery Time: 75 Day
  • Client : Pharma
  • Skills : Regulatory

Regulatory Solutions for Middle East, North Africa, and Europe

Client Challenge
A pharmaceutical company looking to expand its market presence in the Middle East, North Africa (MENA), and Europe faced significant regulatory hurdles. Each region had unique pharmacovigilance and regulatory requirements, and the client lacked the expertise to navigate these complexities. They needed a partner to provide tailored regulatory solutions to ensure compliance and facilitate market entry.

PVigi’s Solution

PVigi delivered customized regulatory solutions to address the client’s needs across the MENA and European markets. Our approach included:

Regulatory Strategy Development:

Conducted a comprehensive analysis of regulatory requirements in key markets, including:

Middle East: Saudi Arabia, UAE, Qatar, Kuwait, Oman, Bahrain, Jordan, Lebanon, Iraq, Iran, Yemen.

North Africa: Egypt, Morocco, Algeria, Tunisia, Libya, Sudan.

Europe: Turkey, Germany, France, UK, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Poland.

Developed a tailored regulatory strategy for each region, ensuring alignment with local and international guidelines.

Pharmacovigilance System Setup:

Established compliant pharmacovigilance systems in each region, including:

Appointment of QPPVs (Qualified Persons for Pharmacovigilance) and LCPPVs (Local Pharmacovigilance Contacts).

Implementation of safety databases and processes for adverse event reporting.

Ensured compliance with EU GVP, ICH guidelines, and country-specific regulations.

Documentation and Submissions:

  • Prepared and submitted regulatory documents, including:
  • Marketing Authorization Applications (MAAs).
  • Risk Management Plans (RMPs).
  • Periodic Safety Update Reports (PSURs).

Managed interactions with regulatory authorities to address queries and ensure timely approvals.

Training and Support:

Outcome
Successful Market Entry: The client achieved regulatory approval and market entry in all targeted regions.

Full Compliance: Tailored solutions ensured compliance with local and international pharmacovigilance regulations.

Efficient Processes: Streamlined regulatory workflows reduced time-to-market and operational costs.

Strong Regulatory Relationships: The client built strong relationships with regulatory authorities, facilitating smoother future interactions.

Client Satisfaction: The client praised PVigi’s expertise and customized approach, leading to a long-term partnership.