Regulatory Support
Dossier creation
Dossiers that meet all national and international requirements and follow all current and legal demands.
- Dossier in CTD (modules 1 – 5 or any requisite module) and eCTD formats for worldwide markets like EU, USA, UK.
- Preclinical and clinical Overviews / Summary writing based on literature search / published studies / journal articles.
- Dossiers for ASEAN and ROW countries in ACTD/ as per country-specific format.
- Dossier reformatting to CTD / eCTD by taking up gap analysis of existing dossiers in line with current requirements.
- Preparation of Drug Master File and Certificate of Suitability (open and closed part).
Dossier review and maintenance
- We will evaluate your technical data through all stages of the development process, review study protocols, and conduct due diligence on your behalf.
- We provide EU-QP services for Pre-clinical and Clinical modules
- Handling of all types of variations (Type Ia, Ib, and II), annual reports, renewals of MAAs, and support in query responses.
Audits
We have a team of qualified and certified auditors who are complete with extensive domain knowledge and experience for gap analysis.
We endeavored to excel at a high level of consistent quality services, teamed with collaborative effort by GxP experts and Engineers. The team members and associates are highly skilled, recognized in the Industry, and baked rich with long-standing practical experience.
We conduct comprehensive audits as per the requirements of cGMP & Regulatory requirements as per UK-MHRA, WHO India, WHO Geneva, USFDA, TGA, and considering country-specific compliance.
- Pre-inspection compliance gap assessment
- Post-inspection compliance gap assessment and support
- Audit for vendor development
Resolution of Inspection
We support our clients in analyzing the deficiencies observed by the regulators and responding to them with enforced actions. We develop strategic plans to address the action, derive the solutions in a collaborative effort that targets a practical compliant, achievable, and fail-proof quality system.
This includes:
- Compliance and response assistance for Post inspection observation by the agency
- Compliance and response assistance for 483’s
- Compliance and response assistance for warning letter compliance
- Compliance and response assistance for sample testing by the agency
- Systematic Remediation – Import Alert, WL, 483’s
- Assessment of the Warning letter/ Import ban of the Organization between the lines;
- Gap analysis of the facility, quality system, product & process, analytics and knowledge;
- Adequacy mapping of the quality attributes for effective investigation, RCA, Impact analysis, CAPA, and Change management;
- Deployment of Quality Matrices, Quality Risk, and Knowledge Management to bridge the gap that appeared in the Warning letter/ Import ban;
- Unit operation and hand-holding of the SMEs to ensure continual enrichment of system and practices by nurturing competency & Team spirit;
- Support to response to the regulatory authority, and prepare to face regulatory inspections.
