PharmAlliance
PharmAlliance is a privately-held, India-based boutique consultancy serving pharmaceutical, biopharmaceutical, API, and medical device manufacturers with cGXP facility design, international regulatory affairs, quality systems, audits, and business development services across 30+ countries.
- Company typePrivate
- Founded2000
- HeadquartersAhmedabad, India
- Headcount1–10
- GTM typeB2B
- OfferingServices
What PharmAlliance does
PharmAlliance is an independent, privately-held professional consulting firm headquartered in Ahmedabad, India, founded in January 2000. It serves pharmaceutical, biopharmaceutical, active pharmaceutical ingredient (API), medical device, and excipient manufacturers — primarily enterprise clients seeking to enter or maintain presence in regulated markets including the USA, Canada, Europe, Australia, South Africa, and Asia. The firm states it has served clients across 30+ countries and operates from a small core team (1–10 employees) led by CEO Asaf Shamsi, who has 30+ years of regulatory and consulting experience.
The company's service portfolio is organized into seven core lines: facility design and project services (cGXP-compliant manufacturing, testing, and R&D facilities); international regulatory affairs (submissions to FDA, TPD, EMEA, EDQM, EU National Authorities, TGA, MCC, and WHO); quality systems development; cGXP and due diligence audits; pre-clinical, clinical, and bioequivalence study support (via a CRO partner network); customized training and education; and business development consulting including sponsor identification and CRAMS outsourcing. Specialized submission services include DMF/EDMF, CEP/COS, and ANDA/ANDS/Abridged MAA preparation. The firm has no proprietary technology platform; its product is human expertise, supported by an international network of CROs, architectural/engineering partners, and industry relationships (including historical ties with CII and IIMA in Ahmedabad).
PharmAlliance monetizes through professional services fees quoted per engagement, with customized packages. It markets primarily via its website, industry articles, seminars, and a referral-driven network. No public financials, funding, or ownership changes are disclosed, and there is no evidence of AI tooling or software product lines — the business is a pure-play knowledge consultancy.
PharmAlliance firmographics
Firmographics- Name
- PharmAlliance
- Legal name
- PharmAlliance
- Website
- https://pharmalliance.com
- Company type
- Private
- Founded year
- 2000
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- PharmAlliance is a privately-held, India-based boutique consultancy serving pharmaceutical, biopharmaceutical, API, and medical device manufacturers with cGXP facility design, international regulatory affairs, quality systems, audits, and business development services across 30+ countries.
- Ownership category
- akta.pro rank
PharmAlliance industry classification
Industry- Product category
- Pharmaceutical Regulatory Consulting
- NAICS
- Management Consulting Services (54161), Other Management Consulting Services (541618)
- SIC
- Services-Management Consulting Services (8742)
- akta.pro primary industry
- Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)
- akta.pro secondary industries
- Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM), Clinical Research Support (CRC/CTA) (EDAOAJAO)
Keywords
Where PharmAlliance is headquartered
LocationHeadquarters
- HQ city
- Ahmedabad
- HQ country
- India
- HQ region
- Asia
Offices1 record
Markets served
PharmAlliance business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Others
Revenue model
- Regulatory Affairs Consulting: Professional consulting services for regulatory submissions, compliance management, cGXP audits, and regulatory approvals for FDA, TPD, EMEA, EDQM, EU National Authorities, TGA, MCC, and WHO. Services include preparation and handling of DMF/EDMF, CEP/COS, ANDA/ANDS, Abridged MAA, and other regulatory submissions.
- Facility Design and Project Services: Consulting for conceptualization, design, and development of state-of-the-art manufacturing, testing, and R&D facilities conforming to international cGXP (GMP, GLP, GCP) norms. Includes modernization of existing facilities.
- Business Development Consulting: Strategic planning, international patent screening, product/market selection, sponsor identification, market penetration strategies, and assistance with contract manufacturing, testing, research arrangements, product licensing, and sales/distribution arrangements.
- Training and Education: Customized training programs, workshops, and seminars covering regulatory affairs, compliance management, GMP, GLP, GCP, validation, and other pharmaceutical industry topics.
- Preclinical/Clinical/Bioequivalence Studies Support: Support services for studies across the entire preclinical and clinical research spectrum including Phase I, II, and III trials as well as bioequivalence studies for European and North American markets.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
PharmAlliance product offering
Product offeringCore offering
PharmAlliance is an independent professional consulting firm providing end-to-end consulting services for the pharmaceutical, biopharmaceutical, API, medical device, and allied industries. Core offerings include international regulatory affairs (DMF/EDMF, CEP/COS, ANDA/ANDS, MAA submissions to FDA, TPD, EMEA, EDQM, TGA, MCC), cGXP-compliant facility design and project services, quality systems development, cGXP and due diligence audits, pre-clinical/clinical/bioequivalence study support, business development consulting, and customized training programs.
Product overview
PharmAlliance is an independent professional consulting firm providing comprehensive, end-to-end consulting services for the pharmaceutical, biopharmaceutical, API, medical device, and allied industries. The company operates as a service-based consultancy rather than a software product company, offering integrated services across facility design and development, international regulatory affairs, quality systems, auditing, clinical research support, training, and business development. The core service portfolio includes facility design conforming to cGXP norms, preparation and handling of regulatory submissions (DMF/EDMF, CEP, ANDA/ANDS/MAA), quality systems development, cGXP audits, pre-clinical/clinical/bioequivalence study support, customized training programs, and international business development consulting including sponsor identification and outsourcing arrangements. The company maintains an extensive database and worldwide contacts to facilitate market entry into regulated markets including USA, Canada, Europe, Australia, and South Africa.
Differentiator
Problem solved
Functional benefit
Products and services
- Facility Design and Development / Project Services Consulting service for pharmaceutical companies that involves conceptualizing and designing state-of-the-art manufacturing, testing, and R&D facilities conforming to international cGXP (GMP, GLP, GCP) norms, including new project implementation and modernization of existing facilities.
- International Regulatory Affairs End-to-end regulatory affairs service for pharmaceutical and biopharmaceutical clients, preparing and handling regulatory submissions to major agencies including FDA (USA), TPD (Canada), EMEA, EDQM, EU National Authorities (MHRA, BfArM), TGA (Australia), and MCC (South Africa).
- Quality Systems Development Service that develops and implements pharmaceutical quality systems, including manufacturing/control systems, SOPs, and related documentation, to achieve full cGXP (GMP, GLP, GCP) compliance.
- cGXP and Due Diligence Audits Audit service that conducts cGXP audits of clients' own facilities to assess compliance, as well as cGXP and due diligence audits of contract or outsourcing facilities on behalf of clients to monitor them for compliance.
- Pre-Clinical, Clinical and Bioequivalence Studies Support Support service for studies across the entire pre-clinical and clinical research spectrum, including Phase I, II, and III trials as well as bioequivalence studies, with delivery for European and North American markets facilitated through reputed CROs.
- Training and Education Customized training programs, workshops, and seminars covering regulatory affairs, compliance management, manufacturing operations, validation, and clinical research, tailored to specific client needs and delivered for all levels of management.
- Business Development Consulting Strategic consulting service assisting clients with planning for international business development, including international patent screening, product/market selection, sponsor identification, feasibility studies, market penetration strategies, and contract manufacturing, testing, research, product licensing, and sales/distribution arrangements.
- Outsourcing Arrangements (CRAMS) Service that assists clients in locating contract manufacturing, testing, or research facilities and joint venture partners for outsourcing in Asian markets, and conducts due diligence and cGXP audits of potential collaborators on behalf of clients.
- Drug Master Files (DMF/EDMF) Services Specialized regulatory service that prepares and files US, Canadian, and European Drug Master Files for APIs, packaging materials, and excipients, including guidance on ICH Q7/US FDA/EU/TPD cGMP compliance.
- Certificate of Suitability (CEP/COS) Services Specialized regulatory service that facilitates certification of APIs and excipients by the European Directorate for the Quality of Medicines (EDQM), including preparation of application dossiers, quality summaries, and EDQM liaison.
- ANDA / ANDS / Abridged MAA Services Specialized regulatory service providing complete guidance for preparation and submission of Abbreviated New Drug Applications (USA), Abbreviated New Drug Submissions (Canada), and Abridged Marketing Authorization Applications (Europe) for generic pharmaceuticals.
- Sponsor Identification Services Specialized service that identifies dosage form manufacturers (sponsors) who can trigger regulatory review of Drug Master Files and guide products through regulatory systems in regulated markets such as the USA, Canada, and Europe.
- Regulatory Affairs Representation Support service providing regulatory affairs representation and liaison services with regulatory agencies including FDA, TPD, EU authorities, EDQM, and regulatory agents for submissions and inspections.
Quantifiable outcome
- Comprehensive support for regulatory submissions in CTD, eCTD, or alternative (national) formats
Companies that use PharmAlliance
Customer profileSegments5 records
Ideal customer profiles4 records
PharmAlliance technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
PharmAlliance partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and minor.
- Confederation of Indian Industry (CII)corePharmAlliance co-organized a seminar on 'Market Penetration and Regulatory Approvals in Europe and USA' with CII Gujarat at the Indian Institute of Management, Ahmedabad (IIMA) on October 25, 2000. The seminar aimed to provide a platform for Indian Pharmaceutical Industry to interact with top-level industry and regulatory experts from India and abroad.
- Indian Institute of Management Ahmedabad (IIMA)coreHost venue partner for the CII-PharmAlliance seminar on Market Penetration and Regulatory Approvals. The seminar featured speakers from Zydus-Cadila, Wockhardt, Intas Pharmaceuticals, and international regulatory experts.
- Contract Research Organizations (CROs) NetworkcorePharmAlliance has links with reputed CROs in USA, Canada, Europe (including Eastern Europe), and India. The company facilitates access to comprehensive resources, expertise, and experience of such reputed CROs for preclinical and clinical studies including Phase I, II, and III trials as well as bioequivalence studies.
- Architectural and Engineering AssociatesminorPharmAlliance has partnered with architectural and engineering firms for facility design and development projects. The company joined hands with reputed architectural and engineering partners as mentioned in PharmaBiz.com coverage.
Scale indicators2 records
Recent moves4 records
Expansion highlights3 records
PharmAlliance competitors and assessment
Company assessmentBroad incumbents
- Parexel International: Global CRO and regulatory consulting firm offering clinical trial, regulatory strategy, and market access services to pharma and biopharma. A broad-incumbent competitor to PharmAlliance on regulatory affairs and clinical study support.
- ICON plc: Major global CRO providing clinical, regulatory, and bioequivalence services across pharma and medical devices. Overlaps with PharmAlliance on pre-clinical/clinical/bioequivalence study support, though at a vastly larger scale and broader scope.
- IQVIA: Global clinical research, regulatory, and commercial services giant serving pharma, biotech, and medical device manufacturers worldwide. A much larger, broad-incumbent alternative that competes on regulatory and clinical study support services that overlap with PharmAlliance's offering.
Direct peers
- ProPharma Group: Global regulatory, compliance, and quality consulting firm serving pharma, biopharma, and medical device manufacturers. Competes directly with PharmAlliance on regulatory submissions, GxP audits, quality systems, and facility compliance consulting.
- Freyr Solutions: Hyderabad-headquartered regulatory affairs and compliance consulting firm serving pharmaceutical, biopharma, and medical device clients across global regulated markets. Direct competitor to PharmAlliance in international DMF, CEP, ANDA, and quality systems services, with a comparable India-based delivery model.
- PharmaLex (Cencora): Large, now Cencora-owned regulatory affairs, quality, and pharmacovigilance consultancy serving global pharmaceutical companies. Overlaps directly with PharmAlliance on regulatory submissions, CMC, GxP compliance, and global market entry support.
- Cunesoft: Regulatory affairs consulting and technology firm helping life sciences companies with eCTD submissions, regulatory strategy, and lifecycle management. Comparable to PharmAlliance in regulatory affairs depth but with stronger technology-enabled submission tooling.
- Navitas Life Sciences: India-rooted (now backed by TAKE Solutions) provider of regulatory, clinical, and pharmacovigilance services to pharma and medical device companies. Overlaps with PharmAlliance on regulatory affairs, clinical study support, and bioequivalence services for regulated markets.
- Arriello Group: Specialist regulatory affairs and quality compliance consultancy serving pharma, biopharma, and medical device companies across Europe, the US, and emerging markets. Direct overlap with PharmAlliance on international regulatory submissions, GxP compliance, and facility/quality systems work.
Regional players
- Skillmine Technology Consulting: India-headquartered consulting firm offering technology and advisory services to healthcare and life sciences clients. Tangentially comparable in serving pharma clients from India, but with a technology rather than regulatory affairs focus.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
PharmAlliance social profiles
Digital presencePharmAlliance financial estimates
Financial estimateRevenue estimate
Valuation estimate
PharmAlliance leadership team
Management profileNumber of profiles
Profiles2 records
PharmAlliance funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
PharmAlliance M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about PharmAlliance
What does PharmAlliance do?
PharmAlliance is an independent professional consulting firm providing end-to-end consulting services for the pharmaceutical, biopharmaceutical, API, medical device, and allied industries. Core offerings include international regulatory affairs (DMF/EDMF, CEP/COS, ANDA/ANDS, MAA submissions to FDA, TPD, EMEA, EDQM, TGA, MCC), cGXP-compliant facility design and project services, quality systems development, cGXP and due diligence audits, pre-clinical/clinical/bioequivalence study support, business development consulting, and customized training programs.
Is PharmAlliance a public or private company?
PharmAlliance is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was PharmAlliance founded?
PharmAlliance was founded in 2000. It employs 1 to 10 people.
Where is PharmAlliance based?
PharmAlliance is headquartered in Ahmedabad, India, in the Asia region.
How does PharmAlliance make money?
Five revenue lines are on record. Regulatory Affairs Consulting is the primary driver. The others are facility Design and Project Services, business Development Consulting, training and Education and preclinical/Clinical/Bioequivalence Studies Support.
Who are PharmAlliance's main competitors?
Broad incumbents on record are Parexel International, ICON plc and IQVIA. Direct peers are ProPharma Group, Freyr Solutions, PharmaLex (Cencora), Cunesoft, Navitas Life Sciences and Arriello Group. Skillmine Technology Consulting is listed as a regional player.
Does PharmAlliance have an API?
No public API is recorded for PharmAlliance.
What industry is PharmAlliance in?
PharmAlliance's product category is Pharmaceutical Regulatory Consulting. Its primary akta.pro industry code is HLAGAKAI, Clinical Quality Assurance (GCP QA, TMF/QMS oversight), with a secondary code of HLAGAHAM, Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC). Its NAICS code is 54161 and its SIC code is 8742.