Navigating the complex landscape of drug regulatory compliance is crucial to ensuring the safety, efficacy, and legality of pharmaceutical products. Protheragen-ING Lab specializes in providing comprehensive regulatory support solutions at all key stages of the drug life cycle, from initial development to post-market surveillance. Our team of experienced professionals is dedicated to helping pharmaceutical companies meet regulatory requirements and achieve successful product approvals.
Professional and customizable drug regulatory compliance services
We offer a range of professional and customizable regulatory compliance services to support pharmaceutical companies throughout the drug development and approval process.
Investigational New Drug (IND) Application
We assist in preparing and submitting IND applications to regulatory authorities, ensuring compliance with all necessary guidelines and regulations. Our team helps streamline the IND process, facilitating the initiation of clinical trials and enabling efficient progression of drug development.
Non-Disclosure Agreement (NDA)
We provide guidance and support in drafting and reviewing non-disclosure agreements to protect sensitive information during interactions with regulatory authorities, partners, and third parties. Our services help safeguard valuable data and maintain confidentiality throughout the drug life cycle.
Abbreviated New Drug Application (ANDA)
For generic drug manufacturers, we offer regulatory consulting services for the preparation and submission of ANDAs. Our experts assist in ensuring compliance with the regulatory requirements set forth by agencies such as the FDA, facilitating the approval and market entry of generic pharmaceutical products.
Biologics License Applications (BLA)
We provide comprehensive support in compiling and submitting BLAs for biologics, including monoclonal antibodies, vaccines, and cell therapies. Our team assists in navigating the intricate regulatory landscape specific to biologics, ensuring compliance and accelerating the approval process.
Comprehensive industry solutions
Our regulatory consulting solutions cater to a wide range of drug types and therapeutic areas. We have extensive experience supporting pharmaceutical companies in various sectors, including:
- Small molecule drugs.
- Biologics and biosimilars.
- Generic pharmaceuticals.
- Over-the-counter drugs.
- Orphan drugs.
- Specialty pharmaceuticals.
- Combination products, such as drug-device combinations.
Regardless of the drug type or therapeutic area, our regulatory experts possess the knowledge and expertise to provide tailored solutions that meet the unique requirements of each project.
Technical service capabilities
Our team combines regulatory expertise with technical proficiency to deliver comprehensive support throughout the drug development process.
Our capabilities include:
- Regulatory Strategy Development: Developing customized regulatory strategies to streamline the approval process and maximize the likelihood of regulatory success.
- Regulatory Submissions: Assisting with the preparation, review, and submission of regulatory documents.
- Compliance Audits: Conducting comprehensive audits of existing regulatory processes and documentation to identify areas for improvement and ensure compliance with applicable regulations.
- Labeling and Advertising Review: Providing expert review and guidance on drug labeling, promotional materials, and advertising campaigns to ensure compliance with regulatory requirements.
Contact us today to learn more about how we can support your regulatory needs throughout the drug life cycle.