About Author
Darshan Singh
Darshan Singh
Co-Founder & Regulatory Consultant — Laafon Galaxy Pharmaceuticals
Two decades in pharmaceutical quality control, quality assurance and drug regulatory affairs — first inside manufacturing plants, now advising them. He writes the technical guides, SOP explainers and regulatory updates published on laafon.com.
Track record
What sits behind the writing
Years in QC, QA & regulatory affairs
Formulation plant setups supported
WHO-GMP audits faced
UK-MHRA inspection faced
State FDA inspections faced
Inspection counts are audits personally attended or hosted in a QC/QA capacity, not audits observed. Plant setups are advisory engagements since 2015.
Career journey
From the QC bench to the consulting desk
Joined in October 2003, straight out of an M.Sc. in Chemistry, and spent three years on the bench.
- Chemical and instrumental analysis of raw materials and finished products — UV-Visible spectrophotometry, HPLC, Karl Fischer titration, dissolution testing and FTIR.
- Preparation and standardisation of volumetric solutions and reagents.
- QC documentation: certificates of analysis, instrument calibration records, SOPs.
- In-process checks on the shop floor alongside production.
The move from testing product to owning the system that releases it.
- Batch manufacturing and packing record review, and batch release documentation.
- Building and maintaining the SOP system across QC, production and stores.
- In-process quality assurance and line clearance discipline.
- Preparing the site for customer and regulatory audits, including WHO-GMP.
Six years in which the role widened from QA into full drug regulatory affairs.
- Regulatory affairs — product permissions, licence endorsements and pharmaceutical labelling.
- Review of SOPs, Master Formula Records and the Site Master File.
- Holding the plant to cGMP under Schedule M and hosting inspections, including the UK-MHRA inspection and further WHO-GMP audits.
- Routine State FDA inspections and the corrective actions that followed them.
Started writing publicly in 2012; went full-time into consulting in July 2015 and built laafon.com as the technical side of the practice.
- Plant setup advisory — layout and flow mapping, room qualification logic and licence documentation for tablets, capsules, liquid orals, injectables and ointments, plus cosmetic, herbal and FSSAI units.
- QMS build-outs: SOP libraries, Master Formula Records and validation protocols against pharmacopoeial standards.
- Revised Schedule M gap assessment and remediation planning for existing sites.
- Export registration support for African markets — PPB Kenya, NDA Uganda and TMDA Tanzania.
- Pharmaceutical plant acquisition and divestment advisory.
Practice areas
What he is asked about
cGMP & Revised Schedule M
Gap assessment against the revised schedule, remediation sequencing and realistic timelines for small and mid-size units.
Plant setup & layout
Room-by-room layout, material and personnel flow, utility sizing and the licence file that has to match the drawing.
QMS documentation
SOPs, Master Formula Records, Site Master File, validation and calibration protocols written to survive an audit.
Audit preparation
Readiness for WHO-GMP, UK-MHRA and State FDA inspections — mock rounds, document trails and response drafting.
CDSCO & state licensing
Product permissions, loan licence routes, DPCO pricing obligations and the state-level variation that catches people out.
Export registration
Dossier preparation for African regulators — PPB Kenya, NDA Uganda and TMDA Tanzania.
Education
- M.Sc. Chemistry — 2003 Kurukshetra University, Kurukshetra
- Diploma in Pharmacy Haryana State Board of Technical Education
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