Regulatory Submission

M22 Pharma has several years of experience in interacting with regulatory agencies such as FDA, health Canada, EMEA. We have a group of talented regulatory experts with experience in different therapeutic areas. Moreover, we are committed to working with you to help guide and position your compound regulatory path leading to wiser decisions which will yield to a successful product approval.

Our team will assess your regulatory needs to successfully prepare and submit your application to regulatory agencies. We start by listening to you and determining where you need to be through a gap analysis and setting a plan in place. We provide sound analysis, recommendations and are proactive to guide in preparing agency communications and provide representations at health authority meetings. We respect the electronic Common Techinical Document (eCTD) format and ensure your application which includes but not limited to, IND, NDA, BLA agrees with all regulatory agency requirements to facilitate a positive technical validation and available to agency reviewers within an ample time frame. Summarily, our process includes:

1. Gap Analysis: Detail review of your Nonclinical and clinical studies and assess for additional documentation for your therapeutic area submission for a successful application approval.
2. Interact with Health agencies: Our highly experience regulatory, clinical and biostatistical scientist starts their involvement with the gap analysis and work with you to develop your submission strategy, agency communication, and accompany you to meet with regulatory authorities
3. Application fillings: We do not end with the initial submission of your application. We work closely with you to address agency responses and requirements as your application is reviewed. We keep your application current and compliant, filing all required submissions such as meeting requests and briefing packages, initial IND and follow-up submissions, protocol amendments, safety reports, annual reports, and other submissions as needed through the application lifecycle such as, for example, special protocol assessments, requests for advice, and cross-application submissions.
4. Scope of our regulatory submission support: Medical and Scientific Writing, and Biostatistics. Our Medical and Scientific Writing department is accustomed to supporting regulatory submissions. We follow ICH Guidelines in writing and publishing eCTD compliant submission documents such as protocols, CSRs, and briefing packages. Our Biostatistics and Statistical Programming department is proficient in supporting submissions from strategic planning, statistical planning for the overall clinical program, and protocol design, sample size determination, and statistical authoring, to performing integrated analyses and production of CDISC compliant submission ready dataset packages (SDTM/ADaM Reviewers Guides and Define.xml files, and SDTM Annotated CRF) and tables/listings/figures.
5. Submission method: We send submissions directly to regulatory agencies on behalf of our clients, using submission gateways where available. 6) Submission experience: M22 Pharma has successfully supported hundreds of submissions to regulatory agencies with zero technical validation findings to date.