Custom Formulation Development:
Innovating for Excellence
Our team of experienced formulation scientists work closely with you to develop innovative and effective formulations for your products. We excel at designing and optimizing formulations for various dosage forms and applications, ensuring optimal stability, efficacy, and consumer appeal. With a focus on quality, safety, and compliance, we deliver exceptional results tailored to your specific needs.
Comprehensive Solutions for Your Formulation and Regulatory Needs
At Eastern Pharma, we understand the complexities of the pharmaceutical, nutraceutical, cosmetic, nutritional, pet food and pet supplement industries. Our team of industry professionals has the knowledge and experience to provide customized solutions that cater to your unique needs. With our comprehensive range of services, we aim to become your trusted partner for all your formulation and regulatory requirements.
Regulatory Affairs & Compliance
Navigating the Complex Landscape
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Regulatory:
Navigating the ever-evolving regulatory environment can be challenging. Our regulatory affairs specialists are well-versed in the latest guidelines and requirements for various industries, particularly those set by the Therapeutic Goods Administration (TGA) and the U.S. Food and Drug Administration (FDA). We ensure your products comply with all relevant regulations, from product registration and dossier preparation to compliance with TGA and FDA guidelines. With Eastern Pharma, you can confidently bring your products to market, knowing they meet the highest standards of regulatory compliance.
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TGAC Compliance:
As qualified specialists with the Therapeutic Goods Advertising Code (TGAC), we are equipped to ensure your advertising and marketing campaigns align with regulatory standards. We can assist in creating compliant advertising content for various platforms, including social media, providing you with the confidence that your marketing efforts meet all necessary guidelines.
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Label Claims:
At Eastern Pharma, we understand the importance of accurate and compliant product claims in line with TGA or FDA regulatory guidelines. Our team can assist in drafting standard claims that align with these guidelines, ensuring your product messaging is both effective and compliant. Additionally, we offer services to review your product labels and claims, providing you with the assurance that your product information adheres to all relevant regulations.
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Listing and registration:
We also specialize in product registration, catering to both regular listed TGA products and new, innovative products backed by substantial scientific studies and evidence. Our team navigates the complex registration process on your behalf, ensuring your products meet all the necessary requirements for market authorization. Whether you're introducing a standard product or a ground-breaking innovation, Eastern Pharma is equipped to guide you through the regulatory landscape with confidence and ease.
Consulting Services:
Empowering Your Business with Expert Insight
Our consulting services provide you with access to a wealth of industry knowledge and experience. We offer guidance on a range of topics, including regulatory strategy, product development, and best practices. Whether you need assistance with a specific issue or are looking for ongoing support, our consultants are here to help you make informed decisions that drive your business forward.
Pharmacovigilance:
In addition to our broad range of services,
we offer specialized pharmacovigilance programs for companies seeking Therapeutic Goods Administration (TGA) listing for their products.
Our team expertly manages the TGA's stringent safety monitoring requirements, including adverse event reporting, safety signal detection, and risk management.
With Eastern Pharma, you can confidently meet the TGA's safety standards and maintain your product's market authorization.
we offer specialized pharmacovigilance programs for companies seeking Therapeutic Goods Administration (TGA) listing for their products.
Our team expertly manages the TGA's stringent safety monitoring requirements, including adverse event reporting, safety signal detection, and risk management.
With Eastern Pharma, you can confidently meet the TGA's safety standards and maintain your product's market authorization.
Certification Mastery:
We understand that each client has distinct requirements and challenges. That's why Eastern Pharma offers a range of customized services designed to address your specific needs. Whether you require assistance with intellectual property, Kosher certification, Halal certification, ISO 13485 (Medical Devices), ISO 22716 (Cosmetics - Good Manufacturing Practices), TGA GMP compliance, or HACCP (Hazard Analysis and Critical Control Point) for food safety, our team is equipped with the specialized expertise you need to achieve your goals. We're committed to helping you navigate the complexities of various industry standards and certifications, ensuring your products meet all necessary requirements for market success.
Quality Control & Assurance
Upholding the Highest Standards
Quality is at the heart of everything we do at Eastern Pharma. Our quality control and assurance experts work diligently to establish and maintain robust quality management systems and processes that adhere to industry best practices. From raw material sourcing to finished product testing, we ensure that your products meet the highest standards of safety, efficacy, and quality.
Training & Educational Programs
Navigating the Complex Landscape
Eastern Pharma is committed to empowering our clients with the knowledge and skills they need to succeed in the competitive marketplace.
We offer a variety of training and educational programs on industry trends, regulatory updates, and best practices. Delivered through webinars, workshops, or customized online sessions, our programs ensure your team stays up-to-date and equipped to excel.
