Spectre is your trusted, one-stop partner for navigating complex global pharmaceutical compliance hurdles seamlessly.
We offer an integrated portfolio of services including Regulatory Affairs, Pharmacovigilance, Clinical Services, and GMP Audits.
Our experienced professional team handles changing global regulatory requirements and industry trends to keep your compliance seamless and worry-free. We ensure total data security and streamline approvals to accelerate your product launch.
Spectre delivers high-precision solutions across seven core compliance domains, backed by rigorous quality control protocols.
CTD / ACTD / eCTD / Country Specific Regulatory guideline complied dossier compilation. Ensuring complete structural accuracy for global submissions.
Preparation of Open part as well as Closed part DMF compilation as per respective regulatory requirements with onsite document evaluation, review and correction services.
Handling BA/BE Studies for regulatory authorities including SRAs. Offered through allied CROs with USFDA, EU, ISP-Chile, NPRA-Malaysia, GCC, WHO, and DCG(I) accreditations. Active in recent requirements for BCS Class II and IV.
Experience handling CT projects of various complex molecules in Oncology, Nephrology, Cardiology, and Rare Diseases. Proven delivery of Post Marketing Surveillance and Irrational Combination Clinical Trials.
Over 15 years of experience offering Pharmacovigilance (PV), Periodic Safety Update Report (PSUR), Risk Management Plan (RMP), Investigator's Brochure (IB), and Protocol/ICF/CRF design.
Utilizing licensed industry software (SAS, Phoenix WinNonlin) to offer Statistical Programming, Expert Data Analysis, Statistical Analysis Plans (SAP), and comprehensive Reporting.
Independent execution of Analytical Method Validation (AMV), Process Validation (PV), Stability Studies, Nitrosamine Testing, Extractable or Leachable Testing, Impurity Profiling, and Monitoring services.
Schedule a strategic consultation with Spectre Pharma representatives at upcoming global regulatory summits and exhibitions.
C/1204, Vandemataram Fabula,
B/H Nirma University, Nr. Malabar County I,
Chharodi, Ahmedabad – 382481,
Gujarat, India