Our team has experts who have good writing skills, relevant medical/scientific education, and experience to produce expertly-written documents – on time. We strive for clarity, efficiency of presentation, and scientific accuracy. All of our medical writing deliverables undergo a rigorous quality editing and QC review to ensure they look good, read well, accurately interpret the study results, and comply with regulatory and stylistic guidelines.
In addition we have dedicated resources which provide regulatory solutions to support clients’ product development programs. We can also provide on-going regulatory support once your product is registered. Our broad functional and therapeutic area expertise enables us to provide specialized inputs to clients according to their needs. We have substantial experience in European regulatory arena.
We provide following services:
Simulated case report
Patient education material
Slide kits for CMEs, training and product launch
Systemic review and meta-analysis
Common Technical Document (CTD)
Quality Review Documents (QRD’s)
Clinical expert statement (CES)
Regulatory assistance for EU (EMEA) compliance to Pharmacovigilance.
Regulatory strategic inputs for Food Supplement/Neutraceutical Development Plan in:
Federal Trade Commission, FTC – USA
Food & Drug administration, FDA – USA
European Food & Safety Authority, EFSA - Europe
Natural health product directorate, NHPD – Canada
Therapeutic Good Administration, TGA – Australia
Food Standards Authority – New Zealand
National Pharmaceutical Control Bureau – Malaysia
Preparation of Product Registration applications, Drug Master Files and Post –approval regulatory submissions (renewals and variations).
Project Management and co-ordination of registration applications including interfacing with Regulatory Authorities on behalf of clients.