Regulatory Affairs

Clinical regulatory services are an important support for all phases of Clinical Trials. With interdisciplinary teams and extensive internal resources companies are flexible and responsible for the smooth running of Clinical Research. The team of regulatory investigators responds to any demand and crisis to avoid issues with non compliances associated with a clinical study. Some major regulatory affairs services are Clinical trial authorizations (CTA), Competent authority meetings, Due diligence, IND/IDE/BLA applications, Local representative, Pediatric investigation plans (PIP), Product labeling, Regulatory consultancy, Reimbursement, Safety risk minimization plans, Scientific advice, protocol assistance, Suitability for registration. A regulatory clinical consultancy monitors the clinical environment, keeping track of any changes in guidelines, regulations and local legislation. Regulatory experts provide country specific support, initial submission, substantial amendment submission, notifications and applications for Managed Access Programs (Medical Need and Compassionate Use Programs) to regulatory bodies for clinical trials in drugs (proof of concept, first in men studies, Phase I to IV trials, registries and non-interventional studies, PAES/PASS studies, academic research, managed access programs, ATMPs,…) devices (clinical investigations pre- and post- CE label) and IVDs (performance evaluations). Companies have experiences in conducting clinical trials complying with regulatory agencies, including FDA, EPA, USDA, OECD, ICH, and JMHW. A Regulatory Outsourcing Services include both pre-approval and post-approval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports and other product lifecycle maintenance tasks. Professional writers can assist clients with regulatory writing such as protocols and protocol amendments, patient information leaflets (PIL), clinical study reports, participant narratives, investigator brochures, integrated summaries of safety and efficacy, literature review summaries, clinical expert reports, Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), Clinical Trial Applications (CTAs), and Module 2 summary documents, IND and NDA annual reports, safety aggregate reports such as Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Experience Reports (PADERs), clinical trial registry synopses, scientific manuscripts; abstracts, posters, eCTD Services, CMC Services etc. Clinical Research Organizations (CROs) supports covers all types of clinical trials covering complex therapeutic areas and studies with sophisticated designs. A niche CRO covers Document Management, Project Management, Clinical Trial Monitoring, Regulatory Affairs Management, Quality Assurance Services, Internal audits/assessments, External audits/assessments, Preparation for FDA audit, Trial master file (TMF) and electronic management. Regulatory and Clinical Trial Support expertise to perform clinical trial monitoring to guarantee that the trial data is accurate, complete and verifiable in agreement with ethical and scientific norms. A team provides independent monitoring and auditing services for clinical and bio-analytical phases of the BA BE study through its highly qualified and experienced monitors. Monitoring services assist as Quality Control (QC) in clinical trial to maintain the integrity of the trial as per the specific standard like ICH Good Clinical Practice (GCP), United States Food and Drug Administration (USFDA), EMEA, ANVISA regulations etc. Pharmaceutical Consulting & Clinical Trial Consulting Services offers regulatory expertise with experience in effective and diplomatic liaison with the concerned committees to support trials in various issues. Clinical strategy and trial support expertise obtain authorization to conduct studies in countries within individual regions for the import of clinical trial supplies and export of samples.