Offerings & Services
- Advisory Services
- Turnkey Project Solutions
- Quality Management Services
- Regulatory Affairs Services
- R&D projects/CDO Management Services
- BE Studies/CRO Management Services
- Technology/Site Transfer
- New Product Strategies
- Global Supply Chain Management
- New manufacturing/R&D Projects
- Business Development and M&A
- Fund Raising Support
- Intellectual Property
- Revenue Cycle Management
- IT & Non-IT staffing solutions
Quality Management Services & Support
- Support CEO as the primary and final accountable for effective Quality Management Systems (QMS) as mandated by regulatory bodies (such as FDA/ICH/EMEA/ISO).
- QMS: Create, enhance, maintain end-to-end system aligned with all regulatory guidelines
- Support responsible Quality Designate (such as Qualified Professional in EU)
- Audits:
- Conduct audits compliant with EDQM/USFDA guidelines
- Perform gap analyses, follow up with sites for corrective and preventive actions (CAPA) closure
- Issue report that can be used in regulatory filings
- Cover sites related to Formulations manufacturing, API, Formulation development, Device manufacturing, Clinical studies
- Manufacturing Systems (contract or inhouse):
- Creation of SOPs, Work Instructions
- Quality tracking with global manufacturers
- Key documents review and creation: SMF, Technical Agreements, Process validation protocol, Specifications
- Annual Product Quality Review (APQR)
- Complaints investigations, gap analyses, CAPA closure
- Batch Release activities:
- Review of batch records (BMR/BPR)
- Third party lab coordination
- Management of country–specific site release procedures as support to Quality Designate
- Qualification & Validation:
- Development of Qualification protocols
- Review, develop and documentation of User Requirement Specification (URS)
- Review of Functional Design Specification (FDS) of equipment
- Support in different Qualification steps i.e., FAT/SAT/DQ/IQ/OQ/PQ
- Artwork development, working with manufacturers, maintenance via change controls
- Regulatory/Certifications submissions:
- Related to eCTD, ANDA, DMF, ISO, CE Mark, UL Mark
- Quality sections creation/review
- Manufacturing Site Transfer: Review of alternate sourcing documents
- Formulation Development: Selection, audit of CDO facilities
- Bioequivalence / Clinical Studies: Selection, audit of CRO facilities
FLEXIBLE ENGAGEMENT MODELS
- Specific project based
- Rent-a-resource: Monthly retainer based
- Resource placement at the manufacturing sites
Business solutions and services
Access to right Products & Funding
BUSINESS DEVELOPMENT
- Strategy and branding
- New Product Strategies – R&D, In licensing, out licensing
- Global product development
- Mergers & Acquisitions
- Advisory services
- Turnkey project solutions
- Fund raising support
Access to integrated Services
TECHNICAL SERVICES
- Project Management
- Facilities Design & Engineering
- Regulatory Affairs – Drug & Device
- Quality Management Systems
- Development Services – Product/Analytical
- API Development Monitoring Support
- Technology/Site Transfers
- Third Party Audit and Compliance
- ISO//CE Mark/UL certifications
- Global Supply Chain Management
- Intellectual Property
Access to right Markets
MARKETING & SALES
- Market Assessment
- Competitor Differentiation
- Strategy and branding
- Pipeline Prioritization
- Competitor and customer perspectives
- Complete organization value maps.
- Implementation planning and support
- Market access: India, EU, US, RoW