ProPharmaCon
ProPharmaCon is a pharmaceutical, device, and cosmetic consulting business established in 2001, providing expertise in regulatory strategy, technical writing, due diligence, quality systems, and promotional reviews. The company aims to offer flexible, high-quality services tailored to client needs, acting as an integral part of their organization to meet aggressive goals.
Industries
Nr. of Employees
small (1-50)
ProPharmaCon
Products
CMC Strategy
Provide strategies for development, CMC changes to approved products, and authoring CMC sections for submissions including INDs, IMPDs, annual reports, and eCTDs.
CMC strategy and support
Chemistry, Manufacturing, and Controls strategy and support consulting services.
Advertising and Promotional Reviews
Review requirements for drugs (Rx/OTC), biologics, devices, and cosmetics, along with promotional strategy assessments and product launch support.
Regulatory Strategy and Submissions
Strategic team leadership for drug and device submission planning, document review, and creation of regulatory SOPs.
Promotional reviews and labeling
Consulting services covering promotional reviews and labeling for drugs, devices, and cosmetics.
Due Diligence
Activities including technical, business, regulatory (including GMP audits), CMC and clinical assessments of products and technologies.
CMC Strategy
Provide strategies for development, CMC changes to approved products, and authoring CMC sections for submissions including INDs, IMPDs, annual reports, and eCTDs.
CMC strategy and support
Chemistry, Manufacturing, and Controls strategy and support consulting services.
Advertising and Promotional Reviews
Review requirements for drugs (Rx/OTC), biologics, devices, and cosmetics, along with promotional strategy assessments and product launch support.
Regulatory Strategy and Submissions
Strategic team leadership for drug and device submission planning, document review, and creation of regulatory SOPs.
Promotional reviews and labeling
Consulting services covering promotional reviews and labeling for drugs, devices, and cosmetics.
Due Diligence
Activities including technical, business, regulatory (including GMP audits), CMC and clinical assessments of products and technologies.
Services
Consulting on CMC development, perform gap analyses and author CMC sections and supporting protocols and reports for regulatory filings.
Strategic leadership for regulatory planning and preparation of submission dossiers, document review and creation of regulatory standard operating procedures.
Conduct cGMP audits and GMP gap analyses; advise on quality system setup, batch review, product release, change control and validation program review.
Prepare scientific and regulatory writing including abstracts, publications, presentations and specialized regulatory submissions.
Technical, regulatory and business due diligence on products and technologies, including follow-up transitional support post-acquisition.
Regulatory review and risk assessment of promotional materials and labeling; copy review and approval and support for launch campaigns and related policies.
Consulting on CMC development, perform gap analyses and author CMC sections and supporting protocols and reports for regulatory filings.
Strategic leadership for regulatory planning and preparation of submission dossiers, document review and creation of regulatory standard operating procedures.
Conduct cGMP audits and GMP gap analyses; advise on quality system setup, batch review, product release, change control and validation program review.
Prepare scientific and regulatory writing including abstracts, publications, presentations and specialized regulatory submissions.
Technical, regulatory and business due diligence on products and technologies, including follow-up transitional support post-acquisition.
Regulatory review and risk assessment of promotional materials and labeling; copy review and approval and support for launch campaigns and related policies.
Expertise Areas
- Regulatory strategy and submissions for drugs, devices and combination products
- CMC strategy, documentation and CMC gap analysis
- Quality systems, cGMP audits and SOP development
- Medical and technical writing for regulatory and scientific communications
Key Technologies
- Electronic regulatory submissions (eCTD)
- CMC documentation and stability protocol design
- cGMP audit methodology
- Quality system and SOP development