Regulatory Consultants one stop solution for a new pharmaceutical product development and covers the array of service under one roof. We are your partner for the development, marketing authorization and registration of quality pharmaceutical, herbal, cosmetics, biological, medical devices and biotechnology products in India and many other countries. We support numerous clients for registration of New Drugs covering Regulatory Consulting, Bio-Equivalence Studies, Clinical Trials, Formulation Development, Stability Studies, Analytical Development & Validation and GCP, cGMP, GLP audits.
Regulatory Consultants is consultancy solution who works with the experts of different fields and offering services as per the requirements of industry. We have kept ourselves updated with current regulatory requirements and our relationship with the experts is due of long term association with them in respective field. We are associated with CROs, SMOs, BA/BE Center, Preclinical Facilities, Analytical Laboratories, Formulation Development R&Ds, Regulatory, Institutes and individual consultants to offer these services. We have multiple partners for one service with different level of understanding so that we can serve in different region of country and also serve from very basic requirements to requirement as per global standard. Our pricing for services are again dependent on the kind of requirement and level of understanding to meet such requirement. Our team has through practical understanding of all these offerings and very well differentiates in need of different customers. We have tried to cover most of the services for development of new pharmaceutical and biotech products and keep on adding the number of services as per need to our customers.
We can be contacted for any of the following services and detail of the same is available in respective section
- Preclinical or Animal studies in GLP or Non-GLP setup
- Formulation Development
- Bio-availability/Bioequivalence Studies
- Phase I to IV Clinical Trial Management
- Analytical Development and Validation
- Stability Studies
- Regulatory Application and Filing with CDSCO
- Site Management Services
- Regulatory Dossier for Export
- Ethics Committees Registration and Accreditation