PharmAlliance.com provides consulting services to the pharmaceutical industry
Title
PharmAlliance
Description
PharmAlliance provides a full line of specialized consulting services to national and international clients in the pharmaceutical, biopharmaceutical, API (active pharmaceutical ingredient), medical device and allied industries, which include:
1) Complete services (including project/engineering consulting services) for conceptualizing, designing and setup of cGXP (GMP, GLP, GCP) compliant manufacturing, testing, or research facilities (new or upgrading)
2) Developing in-house quality systems (operating systems, SOPs, documentation and record-keeping) to help clients achieve cGXP approvals from agencies such as the FDA (USA), EDQM, European national authorities, TPD (Canada), TGA (Australia), MCC (South Africa) the WHO, etc.
3) International regulatory affairs consulting services - complete inputs to ensure generation of the relevant regulatory data (CMC, preclinical, clinical or bioequivalence data) for preparation of regulatory submissions such as INDs, NDAs / ANDAs, MAAs / Abridged MAAs, Drug Master Files (DMFs / EDMFs / APIMFs / CEP / COS applications, etc.) in the CTD, eCTD, or alternative formats, and filing them with regulatory agencies in the USA, EU, Canada, Australia, South Africa, as well as in other countries.
4) PhamAlliance assists overseas clients in locating joint venture partners and / or contract manufacturing / testing / research facilities for outsourcing in the rapidly developing Asian markets, conducts due diligence / cGXP audits of these facilities, and monitors them for regulatory compliance on behalf of clients, and also assists in strategic planning for international business development, including product and market selection, market penetration, and project feasibility studies.
Excerpted from the website:
" Our approach is uniquely designed to focus on keeping on top of market, technological and regulatory developments, as well as building effective relationships with regulatory agencies, healthcare product manufacturers and distributors around the world."
Languages
English
Address
Unit 401, Ashirwad Complex
Opp. Sardar Patel Sewa Samaj Hall
Mithakhali, Ellis Bridge
Ahmedabad 380 006 INDIA
URL: http://www.pharmalliance.com
e-mail: info(at)pharmalliance(dot)com
(Please substitute "@" and "." in the e-mail address when sending e-mail)
Contact
ASAF SHAMSI
CEO & Director, International Operations
asaf(at)pharmalliance(dot)com
(Please substitute "@" and "." in the e-mail address when sending e-mail)
Additional Information
Related Domains
External Links
- API
- Active Pharmaceutical Ingredient
- Animal Healthcare
- Audits
- Biopharmaceutical
- Biotech
- Business Development
- Contract Manufacturing
- Contract Manufacturing Arrangements
- Contract Research
- Distribution Arrangements
- Due Diligence
- Factory Design
- GCP Audit
- GCP Training
- GLP Audit
- GLP Compliance
- GLP Training
- GMP Audit
- GMP Compliance
- GMP Training
- Health Care Industries
- Healthcare
- Human Healthcare
- International Market Development
- Joint Ventures
- MCC Approvals
- MHRA Approvals
- Manufacturing Arrangements
- Market Alliance
- Market Development
- Market Development Planning
- Market Evaluation
- Market Expansion
- Market Opportunities
- Market Penetration
- Medical Devices
- Opportunity Identification
- Pharmaceutical
- Pharmaceutical Project Engineering and Design
- Pharmaceutical Registration
- Pharmaceutical Regulations
- Pharmaceutical Regulatory Affairs
- Plant Approval
- Plant Registration
- Potential Customer Identification
- Pre-inspection Audit
- Product Approval
- Product Registration
- Product Selection
- Project Management
- Registration Services
- Regulatory Affairs
- Regulatory Agencies
- Regulatory Approval
- Regulatory Issues
- Regulatory Services
- Site Approval
- Site Registration
- Strategic Planning
- Strategy Development
- TGA Approvals
- TPD Approvals
- Training
- Training Services
- US FDA Approvals
- cGMP
- cGXP