Regulatory Compliance Services

Regulatory agencies expect that life science companies maintain effective, GxP compliance, validation programs, and operate on risk-based quality management systems across all phases of product life cycle. It is quite possible that in the run for billions of dollars worth of business, lack of compliance could well jeopardize the dreams of Drug development companies.

MakroCare is able to resource and co-ordinate multi-site, QA, GxP, and Validation programs locally and internationally and act as client QA representatives or compliance project managers.

GMP Services:

MakroCare supports Pharmaceutical, Biotech & Device companies in US, Europe & India with view to the implementation of GMP and/or related quality standards. With more than 15 years of practical experience our consultants assure compliance with international Gxp requirements, whereby well trained engineers and technicians guarantee the high quality execution especially of qualification and validation activities – a core competence of MakroCare

Services Include:

  • Gap Analysis / Expert Reports
  • Process Design Review (ICH Q8)
  • Plant Design Review
  • Master Planning (VMP, HMP, SMF, DMF, CEP)
  • Risk Assessment
  • Plant Qualification (DQ, IQ, OQ, PQ)
  • Process Validation (Cleaning, Production, Analytic)
  • IT System Validation (21 CFR11 compliance)
  • Calibration and Commissioning
  • SOP Generation and Review
  • Audit and Auditing Assessment
  • Consulting & Training and much more
Medical Device and IVD

  • Quality management system consulting and implementation
  • Quality manuals, Ex. ISO 13485 / 21 CFR part 820
  • Product / Country specific standards consulting
  • Standards, Biocompatibility, Assurance cases, Testing requirements
  • Risk and Hazards Management support
  • Contract Validation and Oversight support
  • UDI Compliance consulting
  • Audits and Trainings
Quality and Risk management consulting

Medical Device companies need to comply with various quality standards which could be process, product or country specific.
MakroCare has been helping various Medical Device developers and manufacturers, design quality systems and process and helped in implementation of companywide / facility wide Quality Management systems, including establishing required documents, SOPs, controls, and training.
Services offered

Consulting Services:
  • Risk Management Plan development
  • Implementation of ISO 14971 and other regional standards
  • Implementation of ISO 13485, FDA QSR (Part 820) and other regional standards
  • Implementation of Design controls
  • Quality Manual and Risk File establishment
  • Complaints investigation consulting
  • Process and Document Level Risk assessments and Compliance
  • Human Factor Studies
  • Post Market Surveys
  • Change Management
  • Product and Process Risk Mitigation consulting
  • Quality Systems consulting
Functional Services:
  • Assurance cases
  • Design reviews
  • Product risk assessment
  • Hazards file development / Audits
  • Establishing acceptance criteria
  • Risk Traceability and mapping
  • Incident management and tracking
  • MDR filing
  • Risk Communications
  • Label / IFU review
  • Derivative and dependent document updates
  • Clinical Quality and Risk management
  • Clinical Studies’ - Risk Based monitoring
  • Systems and Utilities Validation
  • Clean Room GMP compliance
  • Trainings
  • Qualified Personnel and staffing

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