Regulatory Services

Navigating the complexities of regulatory requirements can be daunting for pharmaceutical companies and drugstores. We can offer comprehensive support to streamline the process, ensuring your products meet all necessary standards and gain market access swiftly.

Our Regulatory Services include:

  • CTD (Common Technical Dossier) Filing: We guide you through preparing and filing your CTD, ensuring that your documentation is complete, compliant, and ready for review.
  • Regulatory File Review: Whether for initial registration or re-registration, we meticulously review your regulatory files in line with CTD requirements to ensure they meet all regulatory standards.
  • E-Submission Support (eCTD): With our expertise in electronic submissions, we help you navigate the eCTD process efficiently, ensuring your electronic documents are properly formatted and submitted.
  • Response to Regulatory Authorities: Receive expert assistance in addressing and responding to deficiency letters from regulatory authorities, ensuring your responses are timely and effective.
  • Stability Study Review and Justification: We offer a thorough review and justification for your stability studies, providing the evidence needed to demonstrate the quality and shelf-life of your products.

Why Choose Our Regulatory Services?

  • Expertise: Our team is equipped with in-depth knowledge of regulatory requirements and best practices to ensure your success.
  • Efficiency: We streamline the regulatory process, reducing delays and helping you achieve faster market access.
  • Support: We’re here to support you from start to finish, offering guidance and solutions tailored to your needs.

Product Development Services

Innovating in the healthcare industry requires a partner who understands product development and shares your commitment to excellence. We specialize in transforming ideas into market-ready products that meet the highest quality and efficacy standards.

Our Product Development Services encompass:

  • Innovative Product Creation: From concept to commercialization, we work with you to develop groundbreaking medical devices, supplements, cosmetics, and personal care products. Our expertise spans formulation development, prototype creation, and scaling up for manufacturing.
  • Troubleshooting Expertise: Encountering challenges during product development is common. Our team excels in identifying and resolving these issues, ensuring your project remains on track. We have the solutions, whether formulation stability, regulatory compliance, or performance optimization.
  • Regulatory Navigation for Post-Approval Changes: Regulations and your products must evolve. We guide you through the process of implementing post-approval changes, ensuring your products continue to meet regulatory standards and market expectations.

Why Partner with Us for Product Development?

  • Comprehensive Expertise: Our team brings together specialists in various healthcare and beauty product development fields, ensuring a holistic approach to your project.
  • Customized Solutions: We understand that each product is unique. Our services are tailored to meet your project’s needs and challenges, ensuring optimal outcomes.
  • Speed to Market: Leveraging our industry experience and regulatory insights, we accelerate the development process, helping you introduce innovative products to the market faster.

Acting As a Responsible Person Services

Entering the Jordanian market with your products can be a seamless process with our help. Suppose you’re a company based outside of Jordan looking to introduce medical devices, supplements, cosmetics, or personal care products into the Jordanian market. In that case, our ‘Responsible Person‘ services are designed to help you. We provide a comprehensive suite of services to ensure your products meet the Jordan Food and Drug Administration (JFDA) standards and thrive in the local market.

Our Services Include:

  • Authorized Representation: We act as your official representative with the JFDA, ensuring your products comply with local regulations.
  • Registered Address Provision: Utilize our local presence as your registered address for JFDA correspondence.
  • Pre-Registration Reviews: Before applying to the JFDA, we meticulously review your products to ensure they meet all regulatory requirements.
  • Technical Documentation Management: We update your technical documentation, ensuring it’s always current and compliant.
  • Technical Documentation Review: Our experts provide detailed assessments of your technical documentation, ensuring accuracy and compliance.
  • Labeling Compliance Advisory: Receive expert advice on labeling requirements, including compliance with local language mandates.
  • Incident Reporting & Complaint Handling: We manage incident reports and customer complaints, ensuring they are addressed per JFDA regulations.
  • Conformity Assessment & Certification Support: We guide you through the conformity assessment and certification processes, ensuring your products meet all regulatory standards.
  • Post-Marketing Safety Surveillance: Stay ahead with our support on safety surveillance activities post-market launch to ensure ongoing compliance and product safety.
  • Jordan Trademark Submissions: We assist with submitting trademarks in Jordan, safeguarding your brand identity.
  • Analytical Activities Follow-Up: Our team manages and follows up on all required analytical testing and activities within Jordan, ensuring your product’s integrity.

Why Choose Goodness Care?

With Goodness Care, you gain a reliable partner who acts as an extension of your team in Jordan. Our in-depth understanding of the JFDA regulations and our commitment to your product’s success makes us the ideal partner for navigating the Jordanian market. Let us handle the regulatory complexities so you can focus on what you do best – creating exceptional products for your customers.

Training Services

Goodness Care is dedicated to advancing the knowledge and skills of professionals in the pharmaceutical industry. We understand the importance of staying updated with industry standards, regulations, and best practices. That’s why we offer a diverse range of in-house and online training workshops tailored to meet the needs of industry professionals, from beginners to experts. Our workshops are designed to provide practical insights and hands-on experience, ensuring participants are well-equipped to excel in their fields.

Explore Our Featured Workshops:

  • Quality Metrics in the Pharmaceutical Industry: Dive deep into the key quality metrics that drive excellence in pharmaceutical manufacturing and quality assurance.
  • Technical Aspects of the Pharmaceutical Industry and Regulatory Affairs: Gain comprehensive insights into the technical intricacies and regulatory landscape affecting the pharmaceutical sector.
  • Cleaning Validation for Cosmetics and Medical Device Manufacturers: Understand the critical importance of cleaning validation and how to implement effective strategies for cosmetics and medical devices.
  • Introduction to ISO 17025 Training: Get introduced to the ISO 17025 standard, focusing on the general requirements for the competence of testing and calibration laboratories.
  • Method of Analysis Development Training: Learn the systematic approach to developing and implementing robust analytical methods tailored to your products and processes.
  • Analytical Methods Validation Training: Master the principles and practices of validating analytical methods to ensure the reliability and accuracy of your testing results.

Why Choose Our Training Services?

  • Expert Instructors: Our workshops are led by industry experts with years of practical experience and deep knowledge in their respective fields.
  • Flexible Learning Options: With both in-house and online formats, our training programs are designed to fit your schedule and learning preferences.
  • Practical & Interactive: We emphasize hands-on learning and real-world applications, ensuring you can immediately apply the knowledge gained.
  • Certification: Participants receive a certificate of completion, validating their expertise and commitment to professional development.

Whether you’re looking to enhance your expertise, stay compliant with industry regulations, or simply broaden your knowledge base, Goodness Care’s training services are your gateway to professional growth in the pharmaceutical industry. Join us and take the next step in your career with confidence.

Reporting Services

We understand the critical role of accurate and comprehensive reporting in the success of pharmaceutical, medical device, and cosmetic products. Our specialized reporting services are designed to support companies in meeting regulatory requirements, making informed decisions, and ensuring product safety and efficacy. Leveraging our expertise, we provide detailed reports that comply with regulatory standards and offer valuable insights for your business.

Our Reporting Services Include:

  • Pharmaceutical Expert Reports: Receive in-depth analysis and documentation covering your pharmaceutical products’ clinical and non-clinical aspects. Our expert reports are tailored to support product development, registration, and post-marketing surveillance efforts.
  • Pharmacokinetics and Bio-Waiver Reports: Our team delivers comprehensive pharmacokinetics reports, including bioavailability, bioequivalence studies, and bio-waiver justifications. These reports are crucial for demonstrating the efficacy and safety of your pharmaceutical products without the need for extensive clinical trials in certain cases.
  • Cosmetic Product Safety Reports: Ensure the safety and compliance of your cosmetic products with our detailed safety reports. These documents thoroughly assess your product’s ingredients, formulations, and potential health risks, fulfilling regulatory requirements and reassuring consumers about product safety.

Pharmacovigilance Services

Our team ensures that your pharmacovigilance system meets and exceeds the stringent requirements of global regulatory authorities. From system setup to ongoing reporting, we provide a full suite of services designed to monitor, evaluate, and improve the safety profile of your medicinal products.

Our Pharmacovigilance Services Include:

  • Pharmacovigilance System Setup: We establish a robust system tailored to your needs, ensuring full compliance with regulatory standards. This comprehensive system includes the development of approved procedures for adverse drug reaction (ADR) reporting, Periodic Safety Update Report (PSUR) development, and the integration of a qualified person for pharmacovigilance (QPPV) with a clear job description. Additionally, we provide targeted training for your staff, equipping them with the knowledge and tools needed to implement and maintain your pharmacovigilance system effectively.
  • PSUR Reporting: Our team prepares Periodic Safety Update Reports (PSURs) for human medicinal products, a critical component of post-market surveillance. This service encompasses:
    • Literature Review: A comprehensive examination of scientific literature and medical sources to stay informed on the latest research and findings.
    • Adverse Drug Reaction (ADR) Assessment: Evaluation and processing of suspected ADRs, ensuring thorough investigation and documentation.
    • Data Analysis: Detailed analysis of your company-specific data to identify trends, risks, and safety concerns.
    • PSUR Preparation: Crafting a customized PSUR, ready for submission, that communicates the safety profile of your products based on rigorous analysis and evaluation.

Sites Inspection and Qualification Services

We provide top-tier auditing and certification services tailored to healthcare product manufacturers. We aim to ensure your manufacturing facilities and analytical labs comply with and exceed safety and quality standards. Leveraging our expertise, we offer comprehensive gap analyses, pre-inspection audits, and support services designed to navigate the complex landscape of regulatory requirements easily.

Our Services Include:

  • Gap Analysis for Pharmaceuticals and Cosmetics: We conduct detailed evaluations of your site against GMP (Good Manufacturing Practice) requirements. This includes thoroughly reviewing your Quality Management Systems (QMS), Standard Operating Procedures (SOPs), and their implementation to identify and address any discrepancies.
  • Gap Analysis for Analytical Labs: Our team assesses your lab’s compliance with ISO 17025 standards, focusing on your quality system and SOPs to ensure best practices in testing and calibration.
  • Pre-Inspection Audits: For sites or labs anticipating regulatory inspections, we offer rigorous pre-inspection audits to prepare you effectively, ensuring you meet all regulatory expectations.
  • Cosmetic Manufacturing Facility Upgrades: We assist in upgrading your cosmetic manufacturing facilities to meet the requirements for registration at the Ministry of Health for General Sales List Products (GSL), ensuring your products meet national safety and quality standards.
  • Manufacturing Facility Compliance with ISO 13485: Our services extend to upgrading your manufacturing facilities to comply with ISO 13485 standards, a prerequisite for the production of medical devices.
  • Site Master File (SMF) Preparation Support: We provide expert guidance in preparing your Site Master File, an essential document that outlines the production and control of pharmaceutical manufacturing operations.
  • Standard Operating Procedures (SOPs) Preparation: Our team aids in developing specific SOPs, ensuring they are tailored to meet your operational needs and regulatory requirements.

Start Your Project Today

Contact us below, and we will get in touch and kick off the discussions on how to work together.