Other Mandate-driven Services: Health Authority Directives

Other Mandate-driven Services: Health Authority Directives

Templarpharma is a regulatory solutions and services company that helps clients navigate complex regulatory frameworks and Other Mandate-driven Services. With a focus on meeting stringent regulatory mandates, Templarpharma offers a range of support services to help clients ensure compliance with regulatory requirements.

Stability Data Services

One of the key services offered by Templarpharma is stability data services. This service involves conducting stability tests to estimate the stable shelf life of a product. Templarpharma offers both real-time and accelerated stability testing services up to shelf life data submissions for three validation batches for Europe. These services are critical for ensuring the safety and efficacy of biopharmaceutical products, which deteriorate and become unstable over time.

Regulatory Submissions of Periodic Safety Update Reports (PSUR)

Another health service offered by Templarpharma is regulatory submissions of Periodic Safety Update Reports (PSURs). Once the product’s registration is complete the PSUR submission becomes an immediate matter to addresses. These reports provide periodic updates on product safety and contain all information regarding the active ingredient, components, combinations, formulation, dosage, indications, and more for diverse populations.

Commitments Made to Health Authority

Templarpharma also offers commitment services, which help clients fulfill commitments made to health authorities. These commitments are mandatory and often relate to the lack of data at a particular point in time. Fulfilling these commitments is essential for gaining marketing approval and ensuring the safety, effectiveness, and recommended usage of a product.

First Time Renewals

In addition to the above services, Templarpharma can help with first-time renewals, which are mandatory in Europe. Marketing authorization (MA) is initially valid for five years, after which we can renew it on the basis of re-evaluation of the benefit-risk balance. Once renewed, the MA is usually valid for an unlimited period of time. However, health authorities may decide to proceed with one additional five-year renewal on justified grounds related to pharmacovigilance.

Additional Renewals in Other Mandate-driven Services

Templarpharma provides a range of support services to help clients comply with regulatory mandates and meet regulatory requirements. Our services include stability data services, PSURs, commitments to health authorities, and first-time renewals. We have a team of experienced regulatory experts who are committed to helping clients overcome regulatory hurdles and achieve their business objectives. Our services include:

  1. Comprehensive regulatory support services tailored to meet your specific needs
  2. A team of experienced regulatory experts with extensive knowledge of global regulations
  3. Assistance with product development and commercialization strategies
  4. Support with regulatory submissions and compliance requirements
  5. Advice on regulatory strategy and risk management
  6. Assistance with GxP compliance and audits
  7. Guidance on clinical trial design and conduct
  8. Support with pharmacovigilance and safety reporting
  9. Assistance with regulatory intelligence and competitor analysis
  10. Support with medical writing and document preparation
  11. Expertise in post-marketing surveillance and vigilance
  12. Assistance with labeling and package insert development
  13. Assistance with electronic submissions and regulatory information management
  14. Guidance on global product registration and market access
  15. Expertise in dealing with regulatory agencies and health authorities worldwide.

We are committed to ensuring that our clients are fully compliant with regulatory requirements and are able to navigate complex regulatory frameworks. We understand that regulatory compliance can be challenging, but with our expertise and commitment to excellence, we can help you achieve your regulatory goals.