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Industries Pharmaceutical Regulatory Documentation
Regulatory Documentation
PM Dimensions regulatory experts have a thorough understanding of the market dynamics and requirements. They prepare documents / dossiers after a detailed review of processes / product documents and then accurately compile the relevant documents leading to guaranteed approval of the dossiers.
Overview
- High quality dossier preparation (CTD / eCTD / ACTD)
- Drug Master Files (DMF)
- Certificate of Suitability (COS / CEP)
- Technical data packages
- Writing product development reports
- Translation of Regulatory documents
Scope of work
- Speedy preparation / compilation and filing of dossiers for regulated. semi regulated and non regulated markets
- Free consultation for pre-product registration
- Validating dossiers prior to submission to the agency
- Prepare expert reports for pre – clinical and clinical data
- Project Management for BA/BE studies, clinical trials, validation & stability studies
- Liaison for process validation, analytical validation, stability studies and related reports
The PM Dimensions Advantage
- Guaranteed approval of dossiers / documentation with the relevant regulatory authorities
- Provide low cost and high quality dossiers in short time frames
- Complete support / guidance for Regulated, non regulated and Semi regulated countries
- Support in go-to-market strategy (market intelligence) & identification of business partners in various markets
- Facilitate partnerships for international bio-equivalence / clinical research studies
- Connect to manufacturers in regulatory markets for importing drugs
Contact Us
To discuss how we can help your organization with your engineering services and workforce development needs, call us on +91 22 67349800 or email us on sales@pmdimensions.com or use this form.