The success of regulatory affairs strategy depend on how they are interpreted, applied, and communicated throughout the pharmaceutical value-chain. We use all collected and filtered data during discovery and development stages in order to register the drug and then market it.
Setting up right strategic plan
Regulatory Affairs plays a critical role in the pharmaceutical industry and is engaged in all phases of drug design, production, growth, after-drug-agreement and marketing.
We provide Regulatory
Affairs Technical Support in:
- Drug Substance Preparation and Drug product registration dossier
- Dossier Preparation & Submissions Support in CTD [(Electronic Common Technical Document (drug registration)] / eCTD
- eCTD electronic Submissions , formats to different Health Authorities of Regulated and Semi-Regulated markets like US-FDA, Health Canada, Europe, UK-MHRA, , ASEAN countries
- Drug Firm Establishment Registration with SFDA [Saudi Arabia’ Food and Drug Administration]
- Drug Listing
- Medical Devices registration