Regulatory affairs services, Regulatory affairs consulting services, Regulatory affairs consultants

Navigating Global Pharma Regulatory Affairs Success

Partner with us to streamline your regulatory processes, mitigate risks, and achieve regulatory success with expert Global Pharma Regulatory Affairs services for seamless compliance.

Our Expertise

Comprehensive Global Regulatory Affairs Services

Our Regulatory Affairs Services cover the entire spectrum of regulatory requirements, from the R&D stage through to post-commercialization of your product. We offer comprehensive support across various facets of regulatory affairs, including white paper preparation, controlled correspondence, submission gap analysis, and dossier compilation with life-cycle management. Our tailored solutions are designed to ensure compliance and regulatory success at every step.

Regulatory Expertise

Trusted Guidance in Regulatory Matters

Benefit from our team's deep knowledge of guidance’s and expertise in Global Regulatory Affairs, ensuring compliance with complex regulations and maximizing your chances of regulatory success with first cycle approval of your drug product from global health authorities within stipulated timeline. We navigate the complex regulatory landscape, guiding pharmaceutical companies through the intricate processes to facilitate approvals and market access for their products.

Proven Track Record

Delivering Results with Confidence

With a proven track record of successful regulatory submissions and approvals, we instill confidence in our clients, demonstrating our ability to navigate regulatory pathways effectively. Our expertise encompasses diverse aspects, including submissions, compliance, strategy development, and liaison with global regulatory authorities.

Tailored Regulatory Solutions

Customized Strategies for Your Needs

We understand that each client's and health authorities regulatory requirements are unique. Our team develops tailored regulatory strategies to address specific challenges and maximize the regulatory compliance to navigate the submission for fast track approval.

Regulatory Compliance Assurance

Ensuring Adherence to Regulations

We offer extensive regulatory compliance support, encompassing meticulous regulatory document due diligence, audits of manufacturing sites, scientific assessments of submitted dossiers, and planned changes in submissions such as variations, annual reports, renewals, supplements, PADER/PSUR for global health authorities.

Building Relationships

Building Trust and Collaboration

Benefit from our established connections and strong relationships with our clients and health authorities. We foster open communication and collaboration, facilitating smoother interactions and faster regulatory processes.

Our Services

Comprehensive Global Regulatory Affairs Services

Regulatory White Paper Preparation

Regulatory White Paper serves as a vital tool for pharma clients, guiding them through the intricate stages of product development from R&D to manufacturing site transfer. By providing comprehensive guidance early in the process, our white paper helps mitigate potential queries from health authorities and streamlines technology transfer to Contract Manufacturing Organizations (CMOs). Included in the white paper are insights into the validation, characterization, and bioavailability/bioequivalence (BA/BE) studies. It serves as a comprehensive guide, empowering clients to navigate regulatory hurdles efficiently and effectively.

USFDA Controlled Correspondence

Our experienced team helps pharmaceutical companies efficiently draft, review, and submit Controlled Correspondence to the USFDA, authorized by a US Agent, to secure concurrence from the USFDA before developing generic drug products. Masuu has filed a wide array of Controlled Correspondence including Q1/Q2 sameness with Reference Listed Drug (RLD), Chemistry Questions, RS Designation, MDD of Drug Product, Alternative BE Approach, Bioequivalence Questions, Inactive Ingredients, Formulation/Overage, Device Evaluation, Guidance Clarification, Drug Shortage, RLD Assignment/Availability/Status, Retention Samples, Labeling Questions, Combination Products, Dissolution Specification, Filing, and more. Trust us to streamline your regulatory communication process and ensure clarity and compliance every step of the way.

Regulatory Due Diligence

Masuu is specialize in Pharma Regulatory Affairs Due Diligence services tailored to meet pharmaceutical and lifescience industries specific needs. Our Regulatory Affairs SMEs conducts comprehensive assessments to evaluate regulatory practices, identify potential gaps or risks, and provide strategic recommendations to enhance compliance and streamline regulatory processes. We help in regulatory compliance assessment, documentation review, strategic recommendations, compliance monitoring as per health authorities regulations, standards, and guidelines.

Regulatory GAP Analysis

Our experts conduct comprehensive Pharma Regulatory Affairs Gap Analysis to assess the regulatory practices at pharmaceutical and lifescience industry and identify areas for improvement and regulatory compliance enhancement. Our comprehensive approach involves review of regulatory documentation, gaps in submission/dossier documentation, assessment of current practices, identification of missing regulatory data, documentation, or processes and regulatory compliance enhancement strategies.

Regulatory Strategy and Dossier Filing

Our Regulatory Affairs SMEs works closely with pharmaceutical and lifescience industry for navigating regulatory pathways throughout the product lifecycle, addressing compliance challenges, or optimizing approvals. Our regulatory SMEs handles all aspects of dossier filing, from preparation to submission. Our Regulatory CMC, Labeling and Clinical SMEs compile all required documentation in CTD, eCTD, ACTD and country specific format’s, ensuring accuracy, completeness, and compliance with global health authorities regulatory requirements. Whether it's for ANDA, NDA, 505(b)(2), IND, ANDS, NDS, MAA, DMF, CEP, ASMF and 510(k) for new product approvals, variations, renewals, or supplements, we ensure your dossier is well-prepared and optimized for fast track and first cycle approval.

Regulatory Scientific Package Preparation

Our specialized team excels in crafting tailored scientific packages designed to support regulatory submissions. The pharmaceutical companies, upon securing approval for their products from a global health authority, can optimize the regulatory filing process through our scientific package preparation approach. This approach enables expedited submissions to additional regulatory bodies by providing a dossier filing rationale without the need for duplicative bioavailability/bioequivalence (BA/BE) studies. Instead, our approach incorporates a bridging study, dissolution justification, and method validation verifications and transfers, allowing for the efficient reuse of approved documentation.

Regulatory Review, Authoring & Dossier Compilation for Global Health Authorities

Masuu Global is excel in Regulatory Review, Authoring & Dossier Compilation services tailored for global health authorities. Our Regulatory SMEs meticulously review supporting raw documents, ensuring justifications align with health authority requirements and compiling a list of documents needed for the dossier (Module 1 to Module 5). Masuu Regulatory CMC project manager prepares comprehensive gap analysis reports, tracking changes in documents to maintain compliance and collaborate closely with clients, sharing draft dossiers for review, incorporating feedback and updates based on client comments followed by conducting standard and peer reviews by internal CFTs (Labeling, IPR, Analytical, Operations, CMC, Clinical and eCTD Publishing teams), addressing all queries and open issues before finalizing the dossier for eCTD conversion and submission to the health authority.

Regulatory Dossier Queries Management

Masuu Global is specialize in Regulatory Dossier Queries Management, ensuring efficient handling of queries received from health authorities. Upon receiving queries, our team of Subject Matter Experts (SMEs) conducts a thorough regulatory assessment to determine the required documents for response and collaborate closely with various departments within pharmaceutical companies to gather the necessary revised documents then prepare proper justifications against each query, ensuring compliance with regulatory requirements. The Regulatory CMC Project Manager prioritize timeliness, ensuring that responses are submitted to the agency before the due date to maintain the product approval goal date.

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