Spectrum Pharmatech Consultants with RAAJ GPRAC form consortium

The venture is aimed to establish a trusted presence in the field of technical and scientific documentation, regulatory affairs and GMP compliance of pharma and biotech industry

Spectrum Pharmatech Consultants (a Spectrum Group company), a cluster of leading consultancy firms, which provides design, engineering and project management services to various sectors across the globe, and Raaj Global Pharma Regulatory Affairs Consultants (RAAJ GPRAC) have formed a consortium to expand their scope of services to global regulatory affairs, and industrial training in pharma, biotech, CRO, BPO and KPO. The venture is aimed to establish a trusted presence in the field of technical and scientific documentation, regulatory affairs and GMP compliance of pharma and biotech industry.

The consortium will focus to spread and share pharma/ regulatory knowledge vide class room training, and develop qualified professional to work in the pharma and biotech industry and thereby contribute in manufacturing healthcare products of required standards.

The consortium will cover the following scope of services.

I. Validation and qualification

• Preparation of validation documents (VMP,EVP,RA,IA)
• Preparation of Qualification protocols (FQ,DQ,IQ,OQ,PQ,FAT/SAT) for equipment and systems
• Preparation of qualification protocols (SRS, RA, PVP, ERES, HLRA, IQ,OQ, PQ) for PLC, HMI, SCADA, Camera System in Compliances with GAMP 5 and 21 CFR Part 11
• Preparation of quality management systems
• Preparation of SOP’s for (production, warehouse, QC, cleaning etc.)
• Execution of qualification process at site and final documentation.

II. Strategic services

• Strategic assistance in pharma regulatory filing
• Support in outsourcing manufacturing or testing laboratories for clients
• Support in outsourcing BA/BE study centres
• Support in DCG(I) licensing & FDA, CDSCO activities

III. Advisory services

• cGMP (current Good Manufacturing Practice) compliance
• Advisory services to queries pertaining to pharma GMP, GLP, QA and regulatory affairs
• Compliance audits as per current and updated statutory pharma regulations
• Critical review of dossiers
• GAP analysis/ due deligence

IV. Technical assistance

• Preparation of drug substance and drug product registration dossier
• Regulatory filing assistance
• Dossier preparation and submissions in CTD [(Electronic Common Technical Document (drug registration)]/ eCTD, ACTD [Asian Common Technical Dossier]
• Non-eCTD electronic Submissions (NeeS) formats to different health authorities of regulated and semi-regulated markets like US-FDA, Health Canada, Europe, UK-MHRA, MCC-SA, ANVISA, ASEAN countries and ROW markets including Indian DCGI and CDSCO
• Preparation of gap analysis reports
• Drug firm establishment registration with US-FDA [United States’ Food and Drug Administration] (FEI [Facility Establishment Identifier].)
• Drug listing in SPL [Structured Product labeling] format, bulk drug listing
• National Drug Code (NDC) and electronic submission
• Preparation of DMF [Drug Master Files]/ ASMF [Active Substance Master File]/ CEP [Certificate of Suitability] or (CoS)/ KDMF/ Technical Packages

V. Training and courses

• Training and mentoring to professionals in pharma industry
• Conducting training and workshops on RA/QA-QM/AD/FD/ICH/CTD/eCTD/ACTD/21CFR parts/ GMP/ GLP/ GCP [Good Clinical Practice]-Clinical etc. with case studies
• Provide different training modules as per the customer specific requirements in RA, QA, cGMP, GLP, GCP, ISO,2 1 CFR parts, audits, validations, QbD, and many more topics
• Provide following different types of training programmes

1. Instructor-led courses
2. In-house company trainings
3. Certificate programmes
4. Distance learning courses
5. Online trainings
6. Fast-track programmes

SPECTRUM in addition to engineering and design, now offers a complete range of services to set up a pharma facility right from conceptualisation till commissioning and further extend our hand holding to our esteemed clients for obtaining regulatory approvals for the facility.

EP News Bureau – Mumbai