Regulatory Consulting
- Ray provides regulatory services through a highly efficient team of specialists and industry experts.
- Highly customized regulatory consultations & solutions.
- Providing regulatory strategy & analysis.
- Partnership through all of steps of the project till obtaining market authorization license.
- Assessment of New molecules & acquisition opportunities.
- Studying agreements & contracts.
- Medical translation & legalizations.
- Review and submission of technical and administrative documents/dossiers to health authorities.
- Maintenance activities (variations and renewals preparation and submission).
- Pricing strategy & assessment.
- Creation of CTD & e-CTD.
- Creation of SOPs and providing the necessary training for implementation.
- Safety & Labelling, revision & submission.
- Promotional Material revision & submission.
- Drug supply & importation processes.
- Audit & GxP support.
- Couching & Training.
- Consistent alignment between Regulatory, CRO, PSP & Pharmacovigilance Teams.
- Bio equivalence studies , In-vitro studies.
- Creation of complete stability studies.
- Finalizing good releases and custom logistics.
- Licensing of warehouses, scientific offices & factories.
- Preparation &submission of company profiles & importation record.
- Preparation & submission of importation plans & requests.
Confidentiality:
- Client confidently is crucial. Protecting clients’ information is legally guaranteed.
Compliance:
- One of our main priorities is to ensure compliant ways of working through well trained and highly professional team.
Meet Our Team:
- Our DRA team is a highly professional team with over 20 years of Regulatory experience.
- Our team is fully aware of health authorities’ regulations & dynamics.
- Our team is well trained and highly qualified and is perfectly capable of implementing best practices & GxP guidelines.
- Our team has a long term experience of partnering with multinational companies & health authorities.
- Client objectives will be achieved through compliant & confidential best practices and in efficient timelines
- Our team has the regulatory experience in Biologics, Medical devices, nutritional, OTC, orphan drugs, pharmaceutical & cosmetic Products.
- Our team is aware of ICH, FDA & EMA processes.