TOSALL Regulatory Affairs and Operations Services aids throughout the development, approval, and post-approval stages of a product’s lifecycle. Our team have extensive experience helping companies achieve the necessary preparation and compliance as required by the FDA, EMEA and other global regulatory bodies. Solutions are customized to suit each client; ranging from supplementary support to a client’s existing team through to a complete outsourced regulatory affairs function.
We do help throughout the development, approval, and post-approval stages of a product’s lifecycle.
- Global Regulatory and Safety Strategy Development Review and Assessment
- Quality and Regulatory Compliance Audits and Training
- Identification, Inspection and Due Diligence
- Reviewing and Assessing Clinical and BE Study Protocols
- CMC, non-Clinical, Clinical Data Review
- Gap Analysis
- Liaison Services with Global Regulatory Agencies
- Translation of Technical Documents Dossier Management
- Project Management
Regulatory Medical and Technical Writing
Our in-house team of domain specific subject matter experts help clients produce clear and suitable regulatory documents, detailing all aspects of the drug development process and CMC. Our experts have experience writing clinical study reports, NDA’s, ISS/ISE’s, and IND applications (including eCTD format).
- Nonclinical and Clinical Overview Writing
- CTD Summary Writing
- Literature Review for Quality/BE studies / Clinical /Non-Clinical Overviews
- Preparation of Summary of Product Characteristic (SmPC), Pack Insert, and Product rationale
- Proficiency in creating detailed NDA, ANDA, ISS, ISE, and IND applications (Module 1, 2, 3, 4 and 5)
- Customized Dossier writing
- Pharmaceutical Development Report (PDR) writing
- Expert Technical Reports on Quality Module 2.3
- Dossier updating from old EU format to CTD/eCTD
- Literature and Brochure for medical devices
- Annual Safety Report Writing
TOSALL’s highly efficient team serves clients with superior quality eCTD and dossier publishing services through a combination of on-shore and off-shore outsourcing. Our solutions highlight the benefits of, and support the transition to, a complete electronic submission strategy.
- Quality and Technical Review
- Conversion of Source Documents to eCTD Standards
- Creation of Navigation Tools
- Consultancy on Country Specific Requirements
Strategic Labeling solutions help companies to effectively complete labeling activities for their products, ensuring regulatory and legal compliance as well as competitive labeling for marketing purposes.
- Labeling and Updates
- Harmonization of Labels
- Readability testing for PIL, Package inserts
- Translation Capabilities with proof reading
- Labeling for Medical Devices
Regulatory Global Submissions
We serve our clients throughout the development, MA approval, and post-approval (variations, updates, notifications, etc.) phases by helping prepare, submit, and follow-up on all submission content to applicable regulatory bodies. Our teams are highly knowledgeable of national and international standards which ensures an efficient process to bring products through approval and to market.
- Abridged Applications, ANDA, OTC, health supplements, complementary medicines application submissions
- Marketing Authorization Applications
- Filing Variation IA, IB and Type II through MRP, DCP or National Procedures
- Renewal Applications
- Global Clinical Trial Applications Phase I to Phase IV
- Medical Devices Dossier Submissions
- Dossier filing through MRP, DCP and National procedures
- Managing Product Life Cycle throughout its shelf-life
- Import and Export License applications (Clinical trial Drugs, Biological Samples)